Tuesday, September 30, 2014
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Recently Activated Clinical Trials
(25 Records found)

 

CTO#: 102116

Status: Active/Enrolling
Sponsor: Novartis (CLEE011A2112C)
A Phase I Dose Escalation Study of LEE011 in Combination with Buparlisib and Letrozole for the Treatment of HR+, HER2-Negative Post-Menopausal Women with Locally Advanced or Metastatic Breast Cancer

Lay Description: The purpose of this clinical trial is to find out if the drugs LEE011 and buparlisib (BKM120), when taken with a standard treatment (letrozole), are safe and beneficial in postmenopausal women with advanced breast cancer. LEE011 and buparlisib are medicines which have not been approved by the Food and Drug Administration for the treatment in women with advanced breast cancer. You will be asked to come to MUSC 12 times over the next three months. After the first three months, you will be asked to come in once a month.

HIPAA
Informed Consent
Protocol

...details...




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.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 102113

Status: Active/Enrolling
Sponsor: GOG (0229O)
A Randomized Phase II Study With A Phase I Lead-In To Assess The Antitumor Efficacy Of The MEK Inhibitor Trametinib Alone Or In Combination With GSK2141795, An AKT Inhibitor In Patients With Recurrent Or Persistent Endometrial Cancer.

Lay Description: The purpose of this study is to determine the effectiveness of Trametinib alone or in combination with GSK2141795 in treating recurrent or persistent endometrial cancer and to determine the types and severity of side effects caused by treatment with these drugs. Trametinib and GSK2141795 are both experimental drugs. Experimental means that the drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA) or similar regulatory agencies in foreign countries. These drugs are being evaluated in endometrial cancer because they act in ways which are thought to be important in the growth and survival of endometrial cancer.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 102089
Kidney
Status: Active/Enrolling
Sponsor: ALLIANCE (A031203)
Randomized Phase II Study Comparing Cabozantinib (NSC #761968 and IND #116059) with Commercially Supplied Sunitinib in Patients with Previously Untreated Metastatic Renal Cell Carcinoma

Lay Description: This study is for adult males and females with advanced or metastatic kidney cancer. Researchers want to find out what effects, good and/or bad, two study drugs called sunitinib and cabozantinib have on you and on advanced or metastatic kidney cancer. Sunitinib has been approved by the FDA and cabozantinib is an investigational drug. Both medications target special proteins that are on the surface of the kidney cancer cell and both drugs are taken by mouth

HIPAA
Informed Consent
Protocol

...details...



CTO#: 102084

Status: Active/Enrolling
Sponsor: AstraZeneca (D3610C00001)
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies

Lay Description: AZD5363 is a new anti-cancer treatment being developed by AstraZeneca that has not yet been approved for use. This study is part of a research project for collecting information about the safety and effectiveness of this treatment for the first time. The main purpose of the study is to establish a safe dose of the drug by gathering information on how well it is tolerated, any potential side effects it may cause and collecting data about how your cancer responds to the drug. The study will also measure the levels of AZD5363 in the blood and the action of AZD5363 in the body over a period of time.

Genetic Research Addendum
HIPAA
Main Informed Consent
Options for Withdrawal of Consent
Patient Participation Card
Pre-Screen Informed Consent
Protocol

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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#: 102078

Status: Active/Enrolling
Sponsor: SWOG (S1400)
Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy Squamous Cell Lung Cancer

Lay Description: This study is for patients that have been diagnosed with squamous cell lung cancer whose tumor has continued to grow despite treatment with initial chemotherapy. The purpose of this study screening step is to perform genetic tests on your tumor sample for certain features that investigational targeted agents used in this study are specifically designed to work against. The the purpose is to assign you a treatment sub-study that is chosen based on the results (genes and proteins called "biomarkers") of this genetic testing on your tumor sample.

MUSC HIPAA Sub-Study A
MUSC HIPAA Sub-Study B
MUSC HIPAA Sub-Study C
MUSC HIPAA Sub-Study D
MUSC HIPAA Sub-Study E
MUSC Screening HIPAA
MUSC Screening Informed Consent
MUSC Substudy A Informed Consent
MUSC Substudy B Informed Consent
MUSC Substudy C Informed Consent
MUSC Substudy D Informed Consent
MUSC Substudy E Informed Consent
Patient Graphics
Protocol
Screening Intro

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CTO#: 102076

Status: Active/Enrolling
Sponsor: Bayer Pharmaceuticals (BAY 1000394 / 14615)
A Randomized, Double Blind, Placebo-Controlled, Multicenter Phase II Study To Evaluate Efficacy And Safety Of Roniciclib In Subjects With Extensive-Stage Disease Small Cell Lung Cancer (SCLC) Who Are Receiving Cisplatin + Etoposide Or Carboplatin + Etoposide As First-Line Therapy

Lay Description: The purpose of this study is to see if subjects diagnosed with small cell lung cancer will benefit from treatment with a study drug called RONICICLIB in combination with chemotherapy

HIPAA
Informed Consent
Patient Contact Card
Patient Drug Diary
Patient Surveys
Protocol
Withdrawal Consent

...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.

HIPAA
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#: 102063
Leukemia, Other
Status: Active/Enrolling
Sponsor: Astellas (2215-CL-0101)
A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

Lay Description: This is for patients that have been diagnosed with either relapsed or refractory (resistant to treatment or cure) myeloid leukemia (AML). The purpose of this study is to see if a medicine called ASP2215 is both safe and effective as a treatment for patients with AML. The purpose of this study also includes determining the maximum tolerated dose. This study also wants to investigate the effect of other drugs on ASP2215. Participants can expect to receive study drug daily and treatment will continue until either participant withdraws from study, study doctor decides to remove participant from study or disease gets worse.

HIPAA
Informed Consent
Protocol
Sub-Study HIPAA
Sub-Study Informed Consent
Take Home Cooler Instructions

...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.

HIPAA
Informed Consent
Protocol

...details...



CTO#: 102037
Melanoma, skin
Status: Active/Enrolling
Sponsor: EMD Serono Inc. (EMR 062235-005)
A Safety Study For MSB0010445 In Combination With Stereotactic Body Radiation In Advanced Melanoma Subjects Following Prior Treatment With Ipilimumab

Lay Description: The purpose of this study is to target the tumor sites in subjects with advanced melanoma that are affected during radiation and to create an immune response (the activity of the immune system against foreign substances) that would potentially destroy surrounding tumors and microscopic disease with fewer harmful effects than other similar drugs. In this research study, MSB0010445, the drug being developed, will be given in combination with Stereotactic Body Radiation Therapy (SBRT, a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body). Radiotherapy is an integral part of the management of advanced melanoma. It provides local tumor control and improvement of symptoms. The subject will be assigned to 1 of 3 dose groups (low dose group, intermediate dose group, or high dose group). Each dose group will receive a different dose level of the study drug. The group to which the subject will be assigned will depend on when they enter the study.

Emergency Medical Support Card
HIPAA
Informed Consent
Protocol

...details...



CTO#: 102034

Status: Active/Enrolling
Sponsor: Amgen, Inc. (20110264)
A Phase Ib/II, Multi-center, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects with Previously Untreated, Unresectable, Stage IIIb-IV Melanoma

Lay Description: The purpose of this study is to find out more about talimogene laherparepvec (formerly known as OncoVEXGM-CSF), in people with advanced melanoma when given in combination with another drug called ipilimumab. Talimogene laherparepvec is a modified herpes simplex type-1 virus (the ‘cold sore’ virus) that has a medicine called human granulocyte macrophage colony-stimulating factor (GM-CSF) added to it. Human GM-CSF is a medicine used to treat patients with white blood cell counts that are low. Talimogene laherparepvec is still experimental and is not approved by the FDA.

Authorization Form and Information
HIPAA
Informed Consent
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.

HIPAA
Informed Consent
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.

HIPAA
IB Version 2 Addedum
Informed Consent
Protocol
Sub Study Consent
Sub Study HIPAA

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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.

HIPAA
Informed Consent
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#: 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.

Arm A Informed Consent
Arm B Informed Consent
HIPAA
Investigator's Brochure (IB)
Protocol
Sub Study 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
Patient Trifold Brochure
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
Emergency Contact Cards
HIPAA
Informed Consent
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...



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