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PARP Inhibitor

Pamiparib for Renal Cell Carcinoma

Phase 2
Waitlist Available
Led By Brian Shuch
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study drug to the date of progressive disease first documented disease progression per recist v1.1 or death due to any cause by investigator assessment, whichever occurs first, assessed up to 3 years after completion of treatment
Awards & highlights

Study Summary

This trial is testing pamiparib, a drug that inhibits proteins that help repair DNA mutations, in combination with temozolomide, a chemotherapy drug, to see if it is effective in treating patients with hereditary leiomyomatosis and renal cell cancer.

Eligible Conditions
  • Renal Cell Carcinoma
  • Kidney Carcinoma
  • Leiomyomatosis and Renal Cell Carcinoma
  • Kidney Cancer
  • Kidney Cell Carcinoma
  • Renal Cell Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of study drug to the date of progressive disease first documented disease progression per recist v1.1 or death due to any cause by investigator assessment, whichever occurs first, assessed up to 3 years after completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug to the date of progressive disease first documented disease progression per recist v1.1 or death due to any cause by investigator assessment, whichever occurs first, assessed up to 3 years after completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Incidence of adverse events (AEs)
Progression-free survival (PFS)
Other outcome measures
Genomic mutational signature (by whole genome sequencing)
Plasma and tumor 2-hydroxyglutarate (2HG), fumarate, and succinate levels

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pamiparib, temozolomide)Experimental Treatment2 Interventions
Patients receive PO BID on days 1-28 and temozolomide PO QD on days 1-7. Cycles repeat every 28 days for up to 36 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pamiparib
Not yet FDA approved
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,050 Total Patients Enrolled
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,814 Total Patients Enrolled
Driven To CureUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently undergoing treatment as part of this trial?

"Correct. The clinicaltrials.gov website states that this medical research is currently receiving applicants, with the trial first posted on October 18 2021 and last updated on October 26 2022. A total of 21 patients need to be enrolled at a single site."

Answered by AI

Is this research endeavor a pioneering effort in the field?

"Initially explored in 2002, Pamiparib has been the focus of clinical research since. The first trial was supported by Schering-Plough and included 60 participants. Following this study it earned its Phase 2 drug approval before now boasting 212 ongoing trials across 40 nations with 986 individual locations."

Answered by AI

Are there still opportunities to participate in this research?

"That is correct. Per the information publicly available on clinicaltrials.gov, enrollment for this trial commenced on October 18th 2021 and has an ongoing need of 21 additional participants at a single medical centre."

Answered by AI

Has the FDA sanctioned Pamiparib for therapeutic use?

"According to our experts at Power, Pamiparib is rated as a '2' on the safety scale. This rating takes into account that it has been proven safe through clinical trials but its efficacy remains uncertain."

Answered by AI

What maladies has Pamiparib been approved to combat?

"Nitrosourea treatment is often administered with Pamiparib and can be advantageous in cases of advanced directives, refractory mycosis fungoides, and recurrent neuroblastoma."

Answered by AI

Has there been previous research conducted on Pamiparib?

"Currently, 212 clinical trials are ongoing with Pamiparib as the primary treatment. Of these studies, 25 have reached Phase 3 of testing. While most take place in Seoul and Songpa, there are 4992 other sites running experiments for this drug."

Answered by AI
~0 spots leftby Apr 2025