PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT03927248|
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: Nivolumab||Phase 1 Phase 2|
PAC-1 in combination with nivolumab: The MTD will be determined using a modified-Fibonacci dose-escalation 3+3 design.
This pilot study will evaluate nivolumab in combination with PAC-1 in subjects with metastatic RCC. Nivolumab will be delivered by IV infusion on Day 1 and PAC-1 will be taken orally on Days 1-28 of each 28-day cycle, and response will be evaluated after every 2 cycles. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject refusal, or subject death either from progression of disease, the therapy itself, or from other causes. Subjects who voluntarily stop the study, have progressive disease, or unacceptable toxicities will be followed for survival every 3 months for 12 months from start of study medication
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Nivolumab and Procaspase Activating Compound-1 (PAC-1) for|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Nivolumab and PAC-1
Patient will be accrued and started on dose 1 level of PAC-1 (500 mg). If no DLT is observed in first cycle of therapy (28 days), dose of PAC-1 will be escalated to 625 mg in second cycle of therapy for the same patient. If patient remains on study and has no dose limiting toxicities, then in third cycle, dose will be escalated to 750 mg and continue in following cycles, if no dose adjustment is needed because of toxicities. Nivolumab will be administered by IV infusion at a dose of 480 mg.
See description in Arms/Groups section
Other Name: PAC-1
- To determine activity of PAC-1 and nivolumab [ Time Frame: 12 months ]Assess by objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- to evaluate the safety profile of nivolumab in combination with PAC-1. [ Time Frame: 12 months ]Toxicities will be defined according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- To measure 3- and 6-months progression-free survival (PFS) rate. [ Time Frame: 12 months ]PFS will be determined by using RECIST 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927248
|Contact: Lisa Wahowske, RN||651-254-1517||Lisa.Wahowske@ParkNicollet.com|
|Contact: Joanna Hill||651-254-2845||Joanna.Hill@ParkNicollet.com|
|Principal Investigator:||Peter Hurley, MD||HealthPartners Institute|