Ignite Creation Date:
2024-05-06 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02986100
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2016-11-14
Brief Title:
Absorption Metabolism and Excretion Following a Single Oral Dose of 14C-Rucaparib
Sponsor:
pharmaand GmbH
Organization:
pharmaand GmbH
Study Overview
Official Title:
An Open-Label Non-Randomized Phase I Study to Assess the Absorption Metabolism and Excretion Following a Single Oral Dose of 14C-Rucaparib in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AME
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-004394-32 | EUDRACT_NUMBER | None | None |