Spots Global Cancer Trial Database for Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

Study Description

Brief Summary: The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered \[14C\] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

Detailed Description: This is a Phase 1, open-label, non-randomized, mass balance study in patients with histologically or cytologically confirmed advanced solid tumors. Approximately 6 patients will be enrolled. The study will consist of 2 parts: a mass balance part (Part I) and a rucaparib treatment part (Part II). Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. If the cumulative recovery of radioactivity exceeds 90% of the administered dose or if radioactivity in urine and feces is \< 1% of the administered dose over a 24 hour period on two consecutive days, as determined by quick counts. In Part II, the treatment with rucaparib in 28-day cycles will continue until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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