Ignite Creation Date:
2024-05-05 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00664781
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2008-04-22
Brief Title:
RucaparibCO-338Formally Called AG-014699 or PF-0136738 in Treating Patients With Locally Advanced or Metastatic Breast Cancer or Advanced Ovarian Cancer
Sponsor:
Cancer Research UK
Organization:
Cancer Research UK
Study Overview
Official Title:
A Cancer Research UK Phase II Proof of Principle Trial of the Activity of the PARP-1 Inhibitor AG-014699 in Known Carriers of a BRCA 1 or BRCA 2 Mutation With Locally Advanced or Metastatic Breast or Advanced Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2016-05
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:
RATIONALE rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying the side effects and best dose of rucaparib and to see how well it works in treating patients with locally advanced or metastatic breast cancer or advanced ovarian cancer
PURPOSE This phase II trial is studying the side effects and best dose of rucaparib and to see how well it works in treating patients with locally advanced or metastatic breast cancer or advanced ovarian cancer
Detailed Description:
OBJECTIVES
Primary
Assessment of Anti tumour activity to PARP-1 inhibitor rucaparib in patients with locally advanced or metastatic breast or advanced ovarian cancer shown to express the BRCA 1 or 2 mutations
To evaluate the toxicity of treatment with Rucaparib in these populations
Secondary
To evaluate the time to progression and overall survival in patients treated with this drug
To study pharmacokinetics of this drug in these patient populations
To evaluate the PolyADP-ribose polymerase PARP activity in peripheral blood lymphocytes from BRCA 1 and 2 heterozygotic patients
To determine a tolerable and effective dosing regimen of the Rucaparib oral formulation
OUTLINE This is a dose-escalation study followed by an open label multicenter study The study was originally set up with an IV formulation An oral formulation of the PARP-1 inhibitor rucaparib will be used from now on Patients are stratified according to tumor type breast vs ovarian and mutation status BRCA 1 vs BRCA 2 In addition patient with high-grade serous ovarian cancer can be enrolled into Stage 1 of the study All patients enrolled will receive PARP-1 inhibitor rucaparib oral formulation once daily for either 7 14 or 21 days of each cycle two possible dosages for 21 days treatment Treatment repeats every 21 days for 12 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable or responding disease may receive additional courses of treatment at the discretion of the chief investigator or Drug Development Office DDO
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacodynamic studies Samples are analyzed for tumor marker CA 125 andor CA 153 measurements rucaparib plasma levels via liquid chromatographymass spectrometrymass spectrometry PARP activity and PARP protein expression via western blotting immunoassays Paraffin embedded sections from original diagnostic biopsy are also collected and analyzed for PARP protein expression via immunohistochemical technique Pleural and ascitic fluid may be collected and analyzed for DNA DS break repair proficiency via immunohistochemical technique Some patients also undergo biopsy of tumors and samples are analyzed for BRCA 2 mutation as well as PARP activity via validated PARP immunoblotting assay
After completion of study treatment patients are followed for 28 days
Peer Reviewed and Funded or Endorsed by Cancer Research UK
Primary
Assessment of Anti tumour activity to PARP-1 inhibitor rucaparib in patients with locally advanced or metastatic breast or advanced ovarian cancer shown to express the BRCA 1 or 2 mutations
To evaluate the toxicity of treatment with Rucaparib in these populations
Secondary
To evaluate the time to progression and overall survival in patients treated with this drug
To study pharmacokinetics of this drug in these patient populations
To evaluate the PolyADP-ribose polymerase PARP activity in peripheral blood lymphocytes from BRCA 1 and 2 heterozygotic patients
To determine a tolerable and effective dosing regimen of the Rucaparib oral formulation
OUTLINE This is a dose-escalation study followed by an open label multicenter study The study was originally set up with an IV formulation An oral formulation of the PARP-1 inhibitor rucaparib will be used from now on Patients are stratified according to tumor type breast vs ovarian and mutation status BRCA 1 vs BRCA 2 In addition patient with high-grade serous ovarian cancer can be enrolled into Stage 1 of the study All patients enrolled will receive PARP-1 inhibitor rucaparib oral formulation once daily for either 7 14 or 21 days of each cycle two possible dosages for 21 days treatment Treatment repeats every 21 days for 12 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable or responding disease may receive additional courses of treatment at the discretion of the chief investigator or Drug Development Office DDO
Patients undergo blood sample collection periodically for pharmacokinetic and pharmacodynamic studies Samples are analyzed for tumor marker CA 125 andor CA 153 measurements rucaparib plasma levels via liquid chromatographymass spectrometrymass spectrometry PARP activity and PARP protein expression via western blotting immunoassays Paraffin embedded sections from original diagnostic biopsy are also collected and analyzed for PARP protein expression via immunohistochemical technique Pleural and ascitic fluid may be collected and analyzed for DNA DS break repair proficiency via immunohistochemical technique Some patients also undergo biopsy of tumors and samples are analyzed for BRCA 2 mutation as well as PARP activity via validated PARP immunoblotting assay
After completion of study treatment patients are followed for 28 days
Peer Reviewed and Funded or Endorsed by Cancer Research UK
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 |
|---|---|---|---|
| EUDRACT-2006-002348-27 | None | None | None |
| CRUK-PH2-052 | None | None | None |
| CRUK-PARPBRCA | None | None | None |
| EU-20842 | None | None | None |