Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03933761
Status:
WITHDRAWN
Last Update Posted:
2021-08-10
First Post:
2019-04-02
Brief Title:
Pamiparib in Fusion Positive Reversion Negative High Grade Serous Ovarian Cancer or Carcinosarcoma With BRCA12 Gene Mutations If Progression on Substrate Poly ADP Ribose Polymerase Inhibitbor PARPI or Chemotherapy
Sponsor:
Australia New Zealand Gynaecological Oncology Group
Organization:
Australia New Zealand Gynaecological Oncology Group
Study Overview
Official Title:
A Phase II Signal-Seeking Trial of the Clinical Benefit Rate Associated With Pamiparib in Subjects With Germline or Somatic BRCA12 High Grade Serous Ovarian Cancer or Carcinosarcoma Who Have Progressed on P-gp Substrate Chemotherapy or PARPi With the Presence of an ABCB1 Fusion and the Absence of a BRCA12 Reversion
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No eligible patient identified after 18 evaluable patients underwent pre-screening over a 2 year period
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISE
Brief Summary:
This study is a phase II multi-centre open label study in patients with advanced ovarian cancer The treatment being tested is Pamiparib with daily dosing
All patients enrolled to the study will receive treatment with pamiparib Patients will be selected for entry into the study based on the molecular signature of their cancer
All patients enrolled to the study will receive treatment with pamiparib Patients will be selected for entry into the study based on the molecular signature of their cancer
Detailed Description:
Ovarian cancer is the deadliest gynaecologic cancer in Western women Although initially responsive to therapy drug resistance commonly evolves
Novel mechanisms of drug resistance in ovarian cancer have been identified and include genetic mutations that result in the activation of a drug efflux pump and secondary mutations in BRCA12 genes that restore the cancer cells ability to repair treatment related DNA damage It is hypothesized that patients with BRCA12 mutant high grade serous ovarian cancer or carcinosarcoma who have progressed on recent therapy and have an activated efflux pump without a secondary BRCA11 mutation will be selectively sensitive to a new PARPi Pamiparib which does not get effluxed out of cancer cells
The primary objective of this trial is to assess the clinical benefit rate at 4 months in 2 cohorts of patients cohort 1 post substrate-PARP inhibitor and cohort 2 post chemotherapy defined as response or absence of progression Secondary objectives are to determine the median progression free and overall survival of patients treated with Pamiparib and the impact on symptom burden and benefit
Novel mechanisms of drug resistance in ovarian cancer have been identified and include genetic mutations that result in the activation of a drug efflux pump and secondary mutations in BRCA12 genes that restore the cancer cells ability to repair treatment related DNA damage It is hypothesized that patients with BRCA12 mutant high grade serous ovarian cancer or carcinosarcoma who have progressed on recent therapy and have an activated efflux pump without a secondary BRCA11 mutation will be selectively sensitive to a new PARPi Pamiparib which does not get effluxed out of cancer cells
The primary objective of this trial is to assess the clinical benefit rate at 4 months in 2 cohorts of patients cohort 1 post substrate-PARP inhibitor and cohort 2 post chemotherapy defined as response or absence of progression Secondary objectives are to determine the median progression free and overall survival of patients treated with Pamiparib and the impact on symptom burden and benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None