Clinical Trials

Cancer Type: Liver


Pro-121

Title: H9H-MC-JBAK(c):Phase 2 Study of LY2157299 in Patients with Hepatocellular Carcinoma 

Description: This study is for patients with hepatocellular carcinoma (liver cancer).

This study is being done to see how safe an investigational drug, LY2157299, is and how well it will work to help people with liver cancer. “Investigational” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). However the FDA has allowed the use of this drug for research.

The main reason for you to take part in this study is to help answer the following research question(s), and not to provide you treatment for your condition.

  • To determine what dose of LY2157299 with or without sorafenib can safely be given to patients with liver cancer.
  • Whether LY2157299 with or without sorafenib can help patients with liver cancer.
  • To evaluate the effect of LY2157299 with or without sorafenib on biomarkers.

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2012-1317

Title: A Phase 3 Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects with MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated with One Prior Systemic Therapy

Description: This study is for patients with a type of liver cancer called Hepatocellular Carcinoma (HCC) and the liver cancer is not suitable for surgical removal or other localized therapy, and prior treatment with sorafenib was either not effective or was not well tolerated.

The purpose of this study is to test a study drug called tivantinib in subjects with liver cancer to find out if it is safe and effective to use.

Subjects enrolled on this study will be randomized (like the flip of a coin) to receive either tivatinib or a placebo (pill that looks like tivatinib but does not contain active medicine). All subjects will take 2 pills in the morning and 2 pills in the evening everyday as long as their cancer is not getting worse and they are not experiencing bad side effects.

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2012-1551

Title: A randomized, double blind, placebo-controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib.

Description: This study is for patients who have hepatocellular carcinoma (HCC) (liver cancer) that has not responded to standard treatment with the drug sorafenib or are not eligible to receive sorafenib.

The study is considered research because the study drug, which is called regorafenib, has not yet been approved by the US Food and Drug Administration (FDA) for the treatment of HCC. Regorafenib works by inhibiting or slowing down the growth of tumors and may prevent cancer from spreading to other parts of the body.

The purpose of this study is to assess if regorafenib in combination with best supportive care is safe and will slow down the growth of tumor or even shrink the tumor and result in increased survival in patients who experienced failure of previous sorafenib treatment.

All subjects on this study will be randomized (like the flip of a coin) to receive either regorafenib or placebo, (a “sugar pill”) that does not contain any active medicine. In addition all subjects will receive best supportive care to manage any symptoms they are experiencing. All subjects will take 4 pills every day for 3 weeks and then have one week of no medicine. This cycle will be repeated until the cancer gets worse or side effects are intolerable.

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2013-0765

Title: BAY 86-9766 / 16553: A prospective, single-arm, multicenter, uncontrolled, open-label Phase II trial of refametinib (BAY 86-9766) in patients with RAS mutant Hepatocellular Carcinoma (HCC).

Description: Subjects in this study have hepatocellular carcinoma (HCC) (liver cancer) that is unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) and a RAS mutation has been detected in the tumor.

The study is considered research because the study drug, which is called refametinib, is under development and has not been approved by the US Food and Drug Administration (FDA) for sale yet.

The purpose of this study is to evaluate if refametinib works and is safe and in patients with liver cancer carrying a specific gene mutation (RAS mutation).

Refametinib is an oral drug that works by stopping the cell growth in cancer cells. It is thought from previous studies that refametinib may help in the treatment of your cancer.

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2014-0025

Title: A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.

Description: The purpose of this study is:

  • To determine if eribulin mesylate (Halaven®) will work better than paclitaxel (Taxol®) for patients with breast cancer who have developed another tumor in the breast area that cannot be removed surgically or who have had the breast cancer spread to another part of the body.
  • To compare all the effects of eribulin mesylate versus paclitaxel on you and the underlying breast cancer.

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Pro-248

Title: FOLFOX PGx: A Pilot Prospective Clinical Trial to use Personalized Medicine through Pharmacogenetics in the Treatment of Gastrointestinal Cancers.

Description: This study is for patients with cancer of the gastrointestinal tract that can be treated with a combination of chemotherapy drugs called 'FOLFOX'.

This treatment is typically given every two weeks; this two week period is termed a 'cycle.' The medicines included in this combination are oxaliplatin, 5-fluoruracil given as a bolus injection over a short term period ('bolus 5-FU'), and 5-fluoruracil given as a continuous 46 hour infusion ('infusional 5-FU'). This combination is widely and commonly used to treat a variety of gastrointestinal cancers, including colon, rectal, pancreatic, and gastroesophageal cancer.

The purpose of this study is to see whether we can use genetic differences in patients to select the right dosages of the three components of the FOLFOX combination to reduce the serious toxicities that these drugs can cause in some patients, and in turn 'personalize' a patient's treatment. This type of genetic testing is called 'pharmacogenetics.

Patients enrolled on this study will provide a blood sample. From this blood sample, DNA will be extracted. The DNA will then be tested for genetic variations. Patients will then have their chemotherapy treatment modified based on the results of this genetic test.

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2014-0429

Title: MK-3475-030: Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited or No Treatment Options.

Description: This protocol is for subjects with metastatic melanoma.

The purpose of the protocol is to make the experimental drug MK-3475 available to patients with metastatic melanoma who have progressed after treatment with approved standard of care agents.

All subjects will receive MK-3475 as a 30 minute infusion through a needle in a vein once every 3 weeks for up to 2 years.

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