Ignite Creation Date:
2024-05-06 @ 12:05 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01482715
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2011-11-22
Brief Title:
A Study of Oral Rucaparib in Patients With a Solid Tumor Phase I or With gBRCA Mutation Ovarian Cancer Phase II
Sponsor:
pharmaand GmbH
Organization:
pharmaand GmbH
Study Overview
Official Title:
A Phase III Open-Label Safety Pharmacokinetic and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor
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:
None
Brief Summary:
Part 1 Completed Enrollment - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors
Part 2A Completed Enrollment and Part 2B Completed Enrollment - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation germline or somatic
Part 3 Completed Enrollment - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor inclusive of lymphoma with evidence of a BRCA mutation germline or somatic
Part 2A Completed Enrollment and Part 2B Completed Enrollment - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation germline or somatic
Part 3 Completed Enrollment - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor inclusive of lymphoma with evidence of a BRCA mutation germline or somatic
Detailed Description:
Rucaparib CO-338 formerly known as PF 01367338 and AG 14699 is an orally available small molecule inhibitor of poly-adenosine diphosphate ADP ribose polymerase PARP being developed for treatment of ovarian cancer associated with homologous recombination HR DNA repair deficiency HRD The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies
An oral formulation is the focus of current development efforts Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations For this study it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation thereby limiting tumor progression and providing therapeutic benefit
An oral formulation is the focus of current development efforts Rucaparib is currently being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2 mutations For this study it is anticipated that rucaparib will promote cell death in the BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation thereby limiting tumor progression and providing therapeutic benefit
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 |
|---|---|---|---|
| 2011-004250-26 | EUDRACT_NUMBER | None | None |