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Advanced Clear Cell Renal Cell Carcinoma Treatment Study

Clinical Trial Title: 
A phase 1, multiple‐dose, dose‐escalation trial of PT2385 tablets, a HIF‐2α inhibitor, in patients with advanced clear cell renal cell carcinoma.
Clinical Trial Protocol ID: 
16092001
Clinical Trial Investigator Name: 
Timothy Kuzel, MD
Clinical Trial Protocol Description: 

To provide PT2385 (study drug) in treatment for patients with advanced renal cell carcinoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have locally advanced or metastatic clear cell renal cell carcinoma (ccRCC) or have mixed histology RCC with a component of ccRCC, and has progressed during treatment with at least 1 prior therapeutic regimen that included a vascular endothelial growth factor (VEGF) inhibitor (Part 1 only).
  • Are at least 18 years of age.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Have a life expectancy of ≥ 3 months.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression. Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after prior anticancer treatment, have discontinued dexamethasone treatment at least 4 weeks before the first study drug administration, and have no ongoing requirement for treatment with dexamethasone or anti-epileptic drugs.
  • Have failed to recover from the reversible effects of prior anticancer therapy. Patients with treatable adverse effects such as hypothyroidism or hypertension may be enrolled if the adverse effect is controlled with treatment.
  • Have uncontrolled or poorly controlled hypertension, as defined by a sustained BP > 140/90, with or without antihypertensive treatment.
  • Have received prior investigational therapy or standard therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Kidney and Urinary System Disorders
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC