Combining pazopanib with abexinostat for advanced kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, double-blind, placebo-controlled trial investigates the efficacy of pazopanib combined with abexinostat compared to pazopanib with a placebo in patients with locally advanced or metastatic renal cell carcinoma (RCC). Patients will be randomly assigned to one of the two treatment groups and monitored for disease progression using RECIST criteria. If patients in the placebo group experience disease progression, they will have the option to switch to the combination treatment. The study aims to evaluate progression-free survival and overall treatment tolerability.

Why it matters

Who can join: the full rules

Inclusion 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 checkpoint inhibitor treatment is allowed in either the (neo)adjuvant or metastatic setting provided screening scans indicate progressive disease (PD) during or following completion of treatment.
* 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.

Exclusion Criteria:

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 are not associated with symptoms, are not considered clinically significant by the investigator, and can be managed with available medical therapies).
* 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 treatment. CNS imaging during Screening is not required unless clinically indicated.
* 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 urothelial carcinoma.
* 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.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting
• University Of UA Cancer Center(UACC)/DH-SJHMC
  Phoenix, Arizona, United States Withdrawn
• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Withdrawn
• UCSF Helen Diller Family Comphrensive Cancer Center - Hemato
  San Francisco, California, United States Withdrawn
• Norton Cancer Institute, Norton Healthcare Pavilion
  Louisville, Kentucky, United States Completed
• Ochsner Clinic Foundation
  New Orleans, Louisiana, United States Completed

Study contacts

• Study coordinator: Sophia Paspal, Ph.D.
• Email: sophia.paspal@xynomicpharma.com
• Phone: 6104055974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.