Disposition of[14C]Pamiparib in Patients with Tumours
Research type
Research Study
Full title
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Pamiparib following Single Oral Dose Administration in Patients with Advanced and/or Metastatic Solid Tumors
IRAS ID
242807
Contact name
Daniel Palmer
Contact email
Sponsor organisation
BeiGene Ltd
Eudract number
2018-001156-36
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
18/NW/0424, REC
Duration of Study in the UK
1 years, 0 months, 13 days
Research summary
Pamiparib is being developed as a potential treatment for cancer. It works by inhibiting a protein involved in repairing DNA damage (PARP). In healthy cells there are other mechanisms for repairing DNA damage, however cancer cells do not have alternative mechanisms to repair DNA damage therefore inhibiting this protein could result in cancer cell death.
Up to 10 patients will be recruited to this single-site study, to ensure that 4 patients complete Part 1 of the study.
Patients in Part 1 (research phase) will receive a single oral dose of pamiparib 60mg radiolabelled with Carbon 14. The radiolabelled substance will allow us to track the movement of the Study Drug and its breakdown products through the body. Patients will remain resident in the unit from Day -1 to Day 7.
Following participation in part 1 or the study, patients have the opportunity to continue treatment in part 2 of the study.
Patients in Part 2 (treatment phase) will receive pamiparib 60mg orally twice a day in 28-day cycles Pamiparib treatment will be continued unless any of the following occur: progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, lost to follow-up, major protocol violation which in the opinion of the Sponsor would have significant impact on the study or its outcome, start of new anticancer therapy, withdrawal by the PI, or study termination by sponsor.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0424
Date of REC Opinion
1 Oct 2018
REC opinion
Further Information Favourable Opinion