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New treatment option for Renal Cell Carcinoma
Official title A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
ClinicalTrials.gov ID: NCT03592472
What this study is testing
What is Pazopanib?
Pazopanib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for renal cell carcinoma.
Also referred to as Votrient®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, Phase 3, double-blind, placebo-controlled study of pazopanib plus abexinostat versus pazopanib plus placebo in patients with locally advanced unresectable or metastatic renal cell carcinoma (RCC).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- To be enrolled in the study, patients will be required to meet all of the following criteria:
- Patients aged ≥ 18 years at time of study entry.
- Patients have histologically confirmed RCC with clear cell component.
- Patients have locally advanced and unresectable or metastatic disease.
- Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.
You likely can't join if
- Patients who meet any of the following criteria at Screening will not be enrolled in the study:
- Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is...
- Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or...
- Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible...
- Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and...
- A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.
See the full eligibility criteria
- To be enrolled in the study, patients will be required to meet all of the following criteria:
- Patients aged ≥ 18 years at time of study entry.
- Patients have histologically confirmed RCC with clear cell component.
- Patients have locally advanced and unresectable or metastatic disease.
- Measurable disease as assessed only by the investigator (not verified by IRC) according to RECIST version 1.1.
- Patients must not have had any prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor treatment in either (neo)adjuvant or locally advanced/metastatic setting. Up to 1 line of prior cytokine or immune...
- Patients have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients have adequate baseline organ function.
- Patients have adequate baseline hematologic function
- Patient must be at least 2 weeks from last systemic treatment or dose of radiation prior to date of randomization.
- Patients who meet any of the following criteria at Screening will not be enrolled in the study:
- Has persistent clinically significant toxicities (Grade ≥ 2; per NCI CTCAE version 5 from previous anticancer therapy (excluding alopecia which is permitted and excluding Grades 2 and 3 laboratory abnormalities if they...
- Has untreated central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided imaging demonstrates no new or progressive metastases obtained at least 4 weeks following completion of...
- Has an additional malignancy requiring treatment within the past 3 years. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ, and non-muscle invasive...
- Poorly controlled hypertension, defined as systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 100 mmHg. Use of anti-hypertensives and rescreening is permitted.
- A new pulmonary embolism or deep venous thrombosis diagnosed within 3 months prior to randomization.
- Has a QTcF interval \> 480 msec.
- New York Heart Association Class III or IV congestive heart failure.
- Use of prohibited medication within 7 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Omaha, Nebraska, United States
- Lake Success, New York, United States
- Rochester, New York, United States
- Kettering, Ohio, United States
- Portland, Oregon, United States
- Easton, Pennsylvania, United States
- Tyler, Texas, United States
- Spokane, Washington, United States
- Beijing, China
- Shanghai, China
- Candiolo, Italy
- Catania, Italy
- Meldola (FC), Italy
- Milan, Italy
- Naples, Italy
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Sacramento, California, United States; San Francisco, California, United States; Louisville, Kentucky, United States; New Orleans, Louisiana, United States; Omaha, Nebraska, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.