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(25 Records found)

 

CTO#: 102085

Status: Active/Enrolling
Sponsor: Eli Lilly (I4T-MC-JVCP(a))
An International Single-Arm Protocol To Provide expanded Accesss To Ramucirumab For The Treatment Of Metastatic Gastric Or Gastroesophageal Juntion Adenocarcinoma Following Disease Pogression Ater Pior Furopyrimidine And/Or Platinum-Containing Cemotherapy

Lay Description: This is an expanded access study for patients with gastric cancer. The purpose of this study is to allow the use of ramucirumab to treat your gastric cancer. The patients on this study will receive ramucirumab (8 mg per kg of your body weight)once every 2 weeks. It will be introduced directly into your blood vessels with the help of an infusion pump and may take about an hour. If your doctor recommends, you will also receive paclitaxel given directly into your blood vessels weekly for 3 weeks, followed by a week without paclitaxel. If you receive both ramucirumab and paclitaxel, your doctor may decide to stop one drug and continue the other for reasons of safety, concern about your welfare, for any other reason, or because you request this be done.It is expected that patients will on this study for as long as your doctor believes it is benefiting you.

HIPAA
Informed Consent
Patient Eligibility Checklist
Patient Safety Card
Protocol

...details...




CTO#: 102048

Status: Active/Enrolling
Sponsor: RTOG (1306)
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC)

Lay Description: This study is for adult subjects who have locally advanced lung cancer with specific gene alterations that cannon be surgically removed. The purpose of this study to to find out what effects, good and/or bad, two experimental treatments vs. standard treatment on their locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement). If the subject's tumor has EGFR mutation, they will be randomized to either: Standard treatment (radiation therapy and chemotherapy) or Experimental treatment #1: erlotinib for three months, then radiation therapy and chemotherapy. If the subject's tumor has ALK rearrangement, they will be randomized to either Standard treatment (radiation therapy and chemotherapy) or Experimental treatment #2: crizotinib for three months, then radiation therapy and chemotherapy.

Consent
HIPAA
Paiten History Form
Patient History Form Instructions
Pill Diary
Protocol

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CTO#: 102028

Status: Active/Enrolling
Sponsor: RTOG (1203)
A Randomized Phase III Study Of Standard Vs. IMRT Pelvic Radiation For Post-Operative Treatment Of Endometrial And Cervical Cancer (TIME-C)

Lay Description: This study is for adult female patients who have endometrial or cervical cancer that has a high risk of coming back in the pelvis or vagina. The purpose of this study is to test whether the use of a radiation therapy delivery technique called intensity-modulated radiation therapy (IMRT) can reduce the amount and severity of gastrointestinal side effects (such as diarrhea) that result from radiation, compared with standard radiation techniques. In this study, patients will get either the IMRT or the standard radiation. Patients in group 1 (often called "Arm A"), you will receive IMRT radiation therapy. This radiation technique is not the standard technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Patients may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the study doctor). Patients in group 2 (often called "Arm B"), will receive standard three-dimensional radiation therapy. This is the standard radiation technique in this setting. The radiation therapy will be given once daily, 5 days a week, for 5-6 weeks. The treatment takes about 5-15 minutes each day. Patients may or may not receive weekly IV cisplatin chemotherapy (this will be decided by the study doctor).

102028-Consent
102028-HIPAA
102028-Protocol
Epic Bowel and Urinary Form
EQ-5D
Fact Cx Form
PQ-PRO-CTAE GI Toxicity Form

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CTO#: 102022

Status: Active/Enrolling
Sponsor: VentiRx Pharmaceuticals (VRXP-A202)
A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Lay Description: The purpose of this research is to evaluate safety and effectiveness of standard treatment along with the the investigational study drug VTX-2337 in adults diagnosed with squamous cell carcinoma of the head and neck (SCCHN) and have previously undergone treatment for SCCHN.

Consent
HIPAA
Protocol

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CTO#: 102010

Status: Active/Enrolling
Sponsor: Merck (EMR 100070-001)
A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0010718C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.

Lay Description: The main purpose of this research trial is to test the investigational drug MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks. Based on this information the sponsor of this study hopes to learn which dose (drug strength) could be best for treatment of subjects. Additional purposes of the trial are to assess side effects of MSB0010718C and to find out whether MSB0010718C has anti-cancer effects. In addition, the sponsor would like to find out how MSB0010718C is processed by the body (this is called pharmacokinetic or PK research). Approximately 380 people will participate in the expansion part of the trial. The research trial will be conducted in up to 130 medical centers in the US and Europe. About 10 of those patients will be enrolled at MUSC under the care of Carolyn Britten, MD.

Consent
HIPAA
Protocol
Sub Study Consent
Sub Study HIPAA

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CTO#: 102007

Status: Active/Enrolling
Sponsor: Pharmacyclics (PCYC-1119-CA)
A Multicenter Phase I/IIb Study of the Bruton?s Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis?) in Subjects with relapsed or relapsed and refractory Multiple Myeloma

Lay Description: This study if for patients that have been diagnosed with muliple myeloma. Pharmacyclics, Inc. (the Sponsor) is studying an investigational new drug called ibrutinib. Ibrutinib is a type of drug called a “kinase inhibitor”. “Kinases” are proteins inside cells that help cells live and grow. The specific kinase inhibited or “blocked” by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing.

Consent
HIPAA
Protocol

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CTO#: 102006

Status: Active/Enrolling
Sponsor: Seattle Genetics (SGN35-012)
A Phase 2 Study Of Brentuximab Vedotin In Relapsed Or Refractory Non-Hodgkin Lymphoma (NHL)

Lay Description: This study is for patients with relapsed or refractory non-Hodgkin lymphoma. The purpose of this research study is to find out what the side effects of Brentuximab vedotin are and whether or not it is effective in the disease or condition being studied. Participants can expect to be in this study for eight 21-day cycles and follow-up visits and/or follow-up phone calls every 12 weeks until the study is closed.

HIPAA
Informed Consent
Protocol
Sub-Study HIPAA
Sub-Study Informed Consent

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CTO#: 102005

Status: Active/Enrolling
Sponsor: Roche Laboratories (NP28903)
A Multi-Center, Open-Label, First-in-Human, Phase I Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6839921, An MDM2 Antagonist, Following Intravenous Administration in Patients with Advanced Malignancies, including Acute Myeloid Leukemia (AML)

Lay Description: This study involves the use of RO6839921, a new investigational drug, which means that it has not been approved by the Food and Drug Administration (FDA). This is the first study using RO6839921 in humans. However in animal studies, RO6939921 has demonstrated the ability to kill cancer cells. At least 3 patients will participate in the initial phase of this study and will be referred to as “Cohort 0”. The patients in Cohort 0 will be given RO6839921 for one cycle of 28 days. After these patients have completed one cycle, the study will be stopped and all of the data from these patients will be reviewed very carefully with the FDA. Once the FDA says it is OK with the results following the treatment of patients in Cohort 0, more patients will be able to join the study. This study will look for the highest safe dose of RO6839921 that can be given to patients with solid tumor cancer (Arm A) or acute myelogenous leukemia (AML) (Arm B). Any side effects associated with the use of RO6839921 will be carefully monitored by your study doctor.

HIPAA
Main Consent
Protocol
Sub Study Consent

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CTO#: 102000
Myeloid and Monocytic Leukemia
Status: Active/Enrolling
Sponsor: COG (ASCT1221)
A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children with Juvenile Myelomonocytic Leukemia (JMML)

No Documents currently available

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CTO#: 101992

Status: Active/Enrolling
Sponsor: MEI Pharma (MEI-004)
A PHASE II OPEN-LABEL, SINGLE-ARM, TWO-STAGE, MULTICENTER TRIAL OF PRACINOSTAT IN COMBINATION WITH AZACITIDINE IN ELDERLY (AGE 65 YEARS OR OLDER)PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)

Lay Description: This study is for patients with newly diagnosed Acute Myeloid Leukemia (AML). The purpose of this research study is to learn how well subjects with AML respond to treatment with pracinostat when it is given with azacitidine. It is also to measure how long the response will last and to evaluate the side effects. Participants can expect to be in this study until one of the following occurs: (1) you withdraw your agreement to continue to take part in this research study; (2) your AML becomes worse; (3) you have severe side effects; (4) or the research study ends.

HIPAA
Informed Consent
Protocol

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CTO#: 101986

Status: Active/Enrolling
Sponsor: ParinGenix Inc. (PGX-ODSH-2013-AML-1)
Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2-O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia

Lay Description: The purpose of the study is to see whether or not the drug ODSH prevents thrombocytopenia (a condition in which there is a lower-than-normal number of platelets in the blood) of Acute Myeloid Leukemia (AML) patients getting induction and consolidation chemotherapy. The drug ODSH is an experimental drug and is not approved by the FDA. ODSH is a derivative of the blood thinner heparin with diminished blood thinning properties. ODSH has been studied in subjects with chronic obstructive pulmonary disease (COPD) and is being studied in pancreatic cancer in combination with chemotherapy. This is a “Pilot Study”. This means that the study will involve a small number of patients and will gather preliminary results. This study will also look at whether ODSH increases the remission rate when combined with chemotherapy for AML and will look at the safety of ODSH in combination with AML chemotherapy. A total of 10 subjects will be enrolled nationwide. About 3 of those subjects will be enrolled at MUSC under the care Alice Mims, MD.

Consent
HIPAA
Protocol

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CTO#: 101983

Status: Active/Enrolling
Sponsor: Pfizer (B1271002)
A Multi-Arm Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Dual PI3K/mTOR Inhibitors PF-04691502 and PF-05212384 in Combination with Experimental or Approved Anticancer Agents in Patients with Advanced Cancer.

Lay Description: This study is for adult males and females who have been diagnosed with cancer. This study involves a new investigational drug called PF-05212384 that is currently not FDA-approved for sale in this country. The first goal of this study is to determine the highest dose of PF-05212384 that can be tolerated without endangering the patients (MTD). When the MTD is found, additional patients will be enrolled to the study to examine the safety and tolerability of PF-05212384 in combination with other study drugs. Each participant will receive only one of the two possible combinations described below of study drugs while in this study. Patients may be in this study for approximately up to 1 year. Depending on the treatment he/she is given, he/she may need to visit the clinic daily, after the initial dose period. The visits to the clinic may then be as much as every 4-6 days during the first 6 “cycles” (each cycle is approximately 28 days) of treatment.

Arm D Dosing Card
Consent
Emergency Contact Cards
HIPAA
Protocol
Study Drug Diary-Arm D(Day 1-Day28)
Study Drug Diary-Arm D(Lead-in Dose)

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CTO#: 101978
Brain and Nervous System
Status: Active/Enrolling
Sponsor: COG (ANBL12P1)
Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High-Risk Neuroblastoma

No Documents currently available

...details...



CTO#: 101977

Status: Active/Enrolling
Sponsor: RTOG (0815)
A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy with or without Short-Term Androgen Deprivation Therapy for Patients with Intermediate-Risk Prostate Cancer

Lay Description: This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer. There are 2 treatment groups in this study: 1) Patients who receive radiation therapy only 2) Patients who receive radiation therapy plus hormone therapy Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

HIPAA
Informed Consent
Protocol

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CTO#: 101972

Status: Active/Enrolling
Sponsor: RTOG (0924)
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Lay Description: The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better. There are 2 treatment groups in this study: 1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles 2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

consent
HIPAA
Protocol

...details...



CTO#: 101971
Brain and Nervous System
Status: Active/Enrolling
Sponsor: ALLIANCE (A071101)
A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, Alliance IND #15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)

Lay Description: This study is for subjects who have a type of brain tumor called a glioblastoma multiforme, which has grown after treatment with the drug temozolomide and radiation therapy. The purpose of this study is to compare the effects on the brain tumor of a vaccine called HSPPC-96 given along with a drug called bevacizumab and compare it to the treatment of receiving bevacizumab alone. The use of HSPPC-96 in combination with bevacizumab is investigational. In this study, participants will be randomized to one of three treatment groups. The group a participant is assigned to will determine the treatment combination that will be given. Participants will be asked to take HSPCC-96 and/or bevacizumab until their tumor comes back. After participants are finished taking HSPCC-96 and/or bevacizumab, the study doctor will ask him/her to visit the office for follow-up exams to keep track of his/her medical condition every 8 weeks up to 18 months from the date of the surgery. After that, participants will be followed for about 5 years so doctors can track their medical condition.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 101967
Corpus Uteri, Other Female Genital
Status: Active/Enrolling
Sponsor: GOG (0277)
A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma

Lay Description: This study is for patients who have a specific kind of uterine cancer; called a leiomyosarcoma that was found only in the uterus; and which has been completely removed by surgery. In this study, we are looking to see if giving chemotherapy with gemcitabine plus docetaxel, followed by doxorubicin, to patients whose leiomyosarcoma was found only in the uterus, decreases the chance that the leiomyosarcoma will come back (recur). In this study half the patients will be managed in the standard way, which is to follow them closely with CT scans, and see if the disease ever comes back. The other half of the patients will be treated with chemotherapy and also followed to see if the disease comes back. Patients will be asked to visit the office for follow up exams approximately every four months for the first three years and then every six months for the next two years after enrollment on this study. At the end of this five year period we would like to keep track of the participants' medical condition for the rest of their lives by calling once a year to see how they are doing.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 101965
Lung
Status: Active/Enrolling
Sponsor: ACRIN (1106)
Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Lay Description: This study is for patients that have been diagnosed with lung cancer who cannot have surgery because of the location of or advanced stage of the cancer or other serious health problems such as emphysema, diabetes, or heart disease. The purpose of this study is to find out if more intense (higher dose) radiation treatment based on the FDG-PET/CT imaging improves treatment of this cancer with the same possible damage to healthy lung tissue compared to treatment with standard radiation therapy. The higher dose radiation is aimed at the tumor. Patients will be randomized into one of two groups; Group A will receive standard radiation treatment once daily, 5 days a week for 5 weeks. They will also will receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Group B will receive radiation treatment once daily, 5 days a week for 3-4 weeks. This radiation treatment will be a higher dose per day than standard radiation. Patients will also receive chemotherapy (paclitaxel and carboplatin), once a week for 6 weeks. Both groups will receive Paclitaxel and carboplatin are given by vein before radiation therapy. Both groups will also receive paclitaxel and carboplatin by vein every 21 days X 3, a total of 3 cycles of chemotherapy four to six weeks after radiation treatment is completed.

FMISO Imaging Consent
HIPAA
Protocol
Treatment Consent

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CTO#: 101946

Status: Active/Enrolling
Sponsor: Chimerix (CMX301XX-CMX001)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients

Consent
Diary Card
EQ-5D-5L Questionnaire
HIPAA
MMSE Questionnaire
Participant Binder
Patient Brochure
Protocol
QLQ-C30
QLQ-HDC29

...details...



CTO#: 101940

Status: Active/Enrolling
Sponsor: Hoffman-LaRoche (BO25114)
A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating The Efficacy And Safety Of Pertuzumab In Combination With Trastuzumab And Chemotherapy In Patients With Her2-Positive Metastatic Gastroesophageal Junction Or Gastric Cancer

Lay Description: This study is for patients with advanced cancer of the stomach or junction of the stomach and esophagus. The purpose of this study is to determine if pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and capecitabine [Xeloda®] or 5-fluorouracil [5-FU]) prolongs life compared with trastuzumab and chemotherapy (cisplatin and capecitabine or 5-FU). Patients on this study will receive Pertuzumab In Combination With Trastuzumab And Chemotherapy. It is expected that patietns will be asked to take study treatment until your disease is no longer responding or unfavorable side effects prevent further treatment.

Capecitabine Dosing Diary
Consent
EORTC QLQ-C30
EORTC-QLQ-STO22
EQ-5D-3L Health Questionnaire
HIPAA
Patient Emergency Card
Pregnant Partner Consent
Protocol

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CTO#: 101938

Status: Active/Enrolling
Sponsor: Pfizer (B2151002)
A Phase 1B Open-Label Three-Arm Multi-Center Study to Assess the Safety and Tolerability of PF-05212384 (PI3K/mTOR Inhibitor) in Combination with Other Anti-Tumor Agents

Lay Description: This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.

Consent
HIPAA
Protocol

...details...



CTO#: 101937
Multiple sites
Status: Active/Enrolling
Sponsor: Plexxicon (PLX119-01)
Phase 1 Study of PLX7486 as Single Agent and With Gemcitabine Plus Nap-Paclitaxel in Patients With Advanced Solid Tumors

Lay Description: This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. The participants in this study will be the first people to receive PLX7486-TsOH. PLX7486-TsOH works by targeting and inhibiting certain molecules that interact with tumor cells. These molecules assist with tumor growth through various functions, including promoting tumor invasion of organs and nerves. By interfering with these molecules, PLX7486-TsOH may help to prevent tumor invasion and kill tumor cells. PLX7486-TsOH has shown anti-cancer activity in laboratory studies; however, it is not yet known whether it will work in humans. Participants will have a screening procedures done to ensure they are eligble to particpate in the trial. If they are eligible and agree to participate, subjects will take the PLX7486-TsOH by mouth daily, come to the MUSC clinic when specified for study tests and procuedres and maintain a drug diary that will be provided to them. Subjects may continue pariticpating in this study as long as they are tolerating the study drug well and their tumor(s) is not growing.

Confidential CRF
HIPAA
Informed Consent
Patient Completion Instructions for Pain Assessment Card
Protocol
Study Coordinator Responsibilities
Study Drug Diary-2a and 2b-Cycle 2 Day 1
Study Drug Diary-Part 1-Cycle 2 Day 1
Study Drug Diary-Part 1-Cycle_Day 1
Study Drug Diary-Part 2a and 2b-Cycle_Day 1

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CTO#: 101925
Myeloid and Monocytic Leukemia
Status: Active/Enrolling
Sponsor: Novartis (CAMN107A US37)
A Phase II Randomized, Multicenter Study of Treatment-Free Remission In Chronic Myeloid Leukemia In Chronic Phase (CML-CP) Patients Who Achieve And Sustain MR4.5 After Switching To Nilotinib

Lay Description: The purpose of this study is to find out if the switching to the study drug, nilotinib (Tasigna) (AMN107, Tasigna) in people who have Chronic Myeloid Leukemia (CML) can help decrease the number of leukemia cells to a very small number. This trial is sponsored by the pharmaceutical company named Novartis. Eligible subjects will receive nilotinib (Tasigna), the study drug, as CML treatment. Nilotinib (Tasigna) is a medicine which has been approved by the United States Food and Drug Administration (FDA) for the treatment of CML. The duration of the study will range from 2 years and up to 6 years.

101925- Spanish Docs, Med Docs Wheel
101925- Spanish Docs, Molecular Monitor FC
101925- Spanish Docs, Pt. Visit Checklist
Biomarker Consent
BioMarker Consent_Spanish
Consent
Consent_Spanish
Consent-Short Form-English
Consent-Short Form-Spanish
Dosing Card
Email letter template
EQ-5D-3L_Spanish
EQ-5D-5L Health Questionnaire
HCP Flashcard
HIPAA
HIPAA_Spanish
MDASI-CML Symptom Inventory
MDASI-CML_Spanish
Med Dose Wheel
Molecular Response-measure of treatment success
Patient screening card
Patient Visit Checklist
Poster
Protocol
Reference Sheet
Referral Mailer
SF-8
Spanish Docs, Wallet CD
Spanish Questionnaire
Treatment Passport
Visit Evaluation Schedule
Waiting Room Flyer
Wallet Card

...details...



CTO#: 101919
Multiple Myeloma
Status: Active/Enrolling
Sponsor: BMS (CA204-006 )
A Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma

Lay Description: This study is for patients with previously untreated multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. The purpose of this study is to determine if elotuzumab given with lenalidomide and dexamethasone is more effective in the initial treatment of multiple myeloma compared with a standard treatment of lenalidomide and dexamethasone alone. This study will also assess the safety of elotuzumab given with lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone. This study will also measure how your body processes elotuzumab. Eligible patients who agree to be in this study will take either two or three study drugs: lenalidomide and dexamethasone either with or without elotuzumab. It is not known how long participation in the study may last. Treatment will continue until the disease gets worse, experience unacceptable side effects, or it is decided it is in the best interest to withdraw from the study.

Blood DNA Consent
Brief Pain Inventory
Chart Flag
Consent Form
Consent Form Addendum
Daily Diary for Elotuzumab_Lenalidomide_Dexamethasone
Daily Diary for Lenalidomide and Dexamethasone
EORTC Multiple Myeloma Module
EORTC QLQ-C30
Flip chart
HIPAA
Patient Dosing Log
Post It Ad
Protocol
Protocol_Blood Sample Amendment
Study ID Card
Sub Study Protocol
Welcome Book
Welcome Website
What you should know Brochure

...details...



CTO#: 101918

Status: Active/Enrolling
Sponsor: Hoffman-LaRoche (BO27938)
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine versus Trastuzumab Adjuvant Therapy for Patients with HER2-Positive Primary Breast Cancer who have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

Lay Description: This study is for patients that have HER2-positive primary non-metastatic breast cancer and had evidence of cancer in your breast and lymph nodes after chemotherapy and trastuzumab. The purpose of this study is to compare the effects, good or bad, of trastuzumab emtansine versus trastuzumab (Herceptin®) on patients' breast cancer to find out which is better. In this study, patients will get either trastuzumab emtansine or trastuzumab alone. Trastuzumab emtansine is an experimental drug, which means that health authorities have not approved trastuzumab emtansine for the treatment of HER2-positive primary non-metastatic breast cancer. Participants will undergo study treatment for fourteen 3 week cycles (42 weeks), unless the disease recurs, the doctor determines that the patients' safety is at risk, or the study is ended by the Sponsor. Even if the patient stops taking study treatment, patients will still be asked to participate in the follow-up period as described above until the study ends.

Biomarker Consent
Consent
HIPAA
Patient Advertisment
Pregnant Partners Consent_HIPAA
Protocol
Subject Eligibility Form

...details...



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