Tuesday, July 22, 2014
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Recently Activated Clinical Trials
(25 Records found)

 

CTO#: 102114

Status: Active/Enrolling
Sponsor: GOG (0286B)
A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Lay Description: This study is for adult women who have advanced or recurrent endometrial(uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Informed Consent/HIPAA
Protocol

...details...




CTO#: 102081

Status: Active/Enrolling
Sponsor: MEI Pharma (ME-344-002)
A Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination with Topotecan (Hycamtin®) in Patients with Solid Tumors

Lay Description: This study is being done to determine how subjects with small cell lung cancer, ovarian cancer and cervical cancer respond to doses of an investigational drug, ME 344 in combination with topotecan, and to determine the dose of ME-344 that can be given in combination with topotecan. "Investigational" means that ME-344 has not been approved by the United States Food and Drug Administration (FDA) for use outside of research studies. Topotecan has been approved by the FDA for treatment of small cell lung cancer, ovarian cancer, and cervical cancer. There are two parts to this study. In Part 1, the study drug will be tested at a certain dose in combination with topotecan in 12 subjects. If no bad side effects happen, the next group of subjects will receive that dose in the study. However, if side effects are seen that are not considered tolerable, then the next group of 12 subjects will receive a lower dose of the study drug. In Part 2, 40 subjects will receive the dose of the study drug that was determined to work best in Part 1 in combination with topotecan. Not all subjects will stay in the study for the same amount of time. Study drug will be given in “cycles” of approximately 28 days each. The number of cycles you receive will depend on how well you tolerate the study drug, and your overall condition.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 102071

Status: Active/Enrolling
Sponsor: SWOG (1216)
A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer.

Lay Description: This study is for patients that have prostate cancer that has spread and are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days. The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.

Informed Consent
Protocol

...details...



CTO#: 102065

Status: Active/Enrolling
Sponsor: SWOG (1310)
Randomized Phase II Trial of Single Agent MEK Inhibitor Trametinib (GSK1120212) Vs 5-Fluorouracil or Capecitabine in Refractory Advanced Biliary Cancer.

Lay Description: This study is for both men and women who have advanced biliary cancer that has come back after initial treatment. Patients will be randomly put in one of two study arms. If they are in Arm 1 the subject will get the experimental drug trametinib by mouth once a day taken on an empty stomach either 1 hour before or 2 hours after food every day until their cancer gets worse or until the side-effects become too severe. If the subject is in Arm 2 they and their doctor will choose one of the standard treatments depending on availability of the drugs – either 5-FU + leucovorin or capecitabine alone. If they get 5-FU + leucovorin, they will get both drugs given into their vein every 2 weeks until their cancer gets worse or until the side-effects become too severe. If they get capecitabine, they will take it by mouth twice a day for 14 days, then rest for 7 days and repeat until their cancer gets worse or until the side-effects become too severe.

Consent
HIPAA
Protocol

...details...



CTO#: 102061

Status: Active/Enrolling
Sponsor: ALLIANCE (A041202)
A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

Lay Description: This study is for male and female patients who are 65 years of age or older who have chronic lymphocytic leukemia (CLL) that has never been treated before, and their disease has progressed to the point that therapy has been recommended. The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease.

Informed Consent/HIPAA
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 cannot be surgically removed. The purpose of this study to evaluate two experimental treatments versus standard treatment for patients with locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement). Participants will receive one of the following treatments: -Standard treatment: radiation therapy and chemotherapy -Experimental treatment #1: erlotinib for three months, then radiation therapy and chemotherapy. -Experimental treatment #2: crizotinib for three months, then radiation therapy and chemotherapy.

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

...details...



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.

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

...details...



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 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

...details...



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: This study is for patients that have been diagnosed with advanced solid tumor cancer and their disease may not have responded to available treatments. This study is testing the investigational drug, MSB0010718C. "Investigational" means that this drug has not been approved by the FDA. The main purpose of this study is to test MSB0010718C at different dose levels to see if it is safe and well-tolerated in patients when given once every two weeks.

Consent
HIPAA
Protocol
Sub Study Consent
Sub Study HIPAA

...details...



CTO#: 102009

Status: Active/Enrolling
Sponsor: SWOG (1203)
A Randomized Phase III Study of Standard Cytarabine Plus Daunomycin (7+3) Therapy versus Idarubicin with High Dose Cytarabine (IA) with or without Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Lay Description: This study is for adult male and female patients with previously untreated acute myeloid leukemia (AML). The purpose of this study is to compare the effects, good and/or bad of three drug combinations. The first combination is the standard treatment of daunorubicin plus AraC. The second combination is another standard treatment of idarubicin plus AraC. The third combination will add the drug vorinostat to the standard IA therapy. The study team wants to see if the study treatments will get rid of leukemia cells and keep them from coming back for patients who may benefit from stem cell transplant. They also want to find stem cell transplant donors for patients who might benefit from a transplant according to standard practice, beginning at the time patients register for the study. Participants will be asked to take induction treatment for 1-2 months. If a participant gets consolidation, it could take from 1-4 months. Participants may go on to transplant any time in the next year after he/she goes into remission. After participants are finished with the study treatment, the study doctor will ask them to visit the office for follow-up exams for at least 5 years from the time they go into remission.

Informed Consent/HIPAA
Protocol

...details...



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 is for patients that have been diagnosed with multiple 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. The study has two parts: • Phase 1 tests different doses of ibrutinib and carfilzomib together to study what dose to use in Phase 2b • Phase 2b will study the effects of the treatment. All subjects will receive carfilzomib, only half of the subjects will receive ibrutinib, to test if there is a benefit to adding ibrutinib to carfilzomib treatment Participation in this study will last approximately two years. This will include coming to the study center for treatment and follow-up after the study treatment ends.

Consent
HIPAA
Patient Drug Diary
Protocol

...details...



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 evaluate the side effects of brentuximab vedotin and study whether it is effective in treating relapsed or refractory Non-Hodgkin Lymphoma

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

...details...



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

...details...



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 a drug called Pracinostat when it is given with another drug called, Azacitidine. This study will also measure how long the response will last and to evaluate the side effects. Participants can expect to be in this study until the patient's disease beomes worse, side effects become severe or if the patient withdraws consent to participate in the study.

HIPAA
Informed Consent
Protocol

...details...



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 study is for patients that have Acute Myeloid Leukemia (AML). 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.

Consent
HIPAA
Protocol

...details...



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 signficant side effects. When the highest dose is found, additional subjects will be enrolled to the study to examine the safety and tolerability of PF-05212384 in combination with other study drugs.

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)

...details...



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 that have 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.Prior studies have suggested possible advantages to the administration of hormonal therapy with radiation. However, those studies were performed with radiation techniques that do not match those commonly used in clinical practice today (that is, dose-escalated radiotherapy). Therefore, we will be testing to see if similar benefits for hormonal therapy are seen when used with current radiation therapy techniques.

HIPAA
Informed Consent
Protocol

...details...



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.

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.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 101970

Status: Active/Enrolling
Sponsor: SFJ Pharmaceuticals (AP311736)
A Randomized Double-Blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk or Recurrent RCC

Lay Description: This study is for patients with kidney cancer. The purpose of this study is to investigate the safety and effectiveness of a study drug, axitinib, after surgery for subjects with "high risk" recurrence of kidney cancer. Patients on this study will receive axitinib or placebo. It is expected that patients will be on this study for up to 3 years with a minimum of 1 year. The standard study period will be approximately 3-6 years.

HIPAA
IB
Informed Consent
Patient Diary
Patient Participation Card
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- a leiomyosarcoma that was found only in the uterus, and which has been completely removed by surgery. In this study, researchers 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 or recur.

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 advanced stage or location 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 without increased damage to healthy lung tissue compared to treatment with standard radiation therapy.

FMISO Imaging Consent
HIPAA
Protocol
Treatment Consent

...details...



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

Lay Description: This study is for patients that have undergone or are about to undergo a hematopoietic cell transplant and have evidence of previous infection with a virus known as cytomegalovirus (referred to as “CMV”). The main purpose of this study is to find out whether an experimental drug called CMX001 can be used to prevent CMV infection after hematopoietic cell transplant.

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).

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

...details...



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