Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03330405
Status:
TERMINATED
Last Update Posted:
2023-10-13
First Post:
2017-10-16
Brief Title:
Javelin Parp Medley Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A PHASE 1B2 STUDY TO EVALUATE SAFETY AND ANTI TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH THE POLYADENOSINE DIPHOSPHATE ADP-RIBOSE POLYMERASE PARP INHIBITOR TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated since there was no need for further safety or efficacy data to be collected The participants having benefit from the investigational treatments have been moved to a continuation study NCT05059522
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Avelumab in combination with talazoparib will be investigated in patients with locally advanced primary or recurrent or metastatic solid tumors including non-small cell lung cancer NSCLC triple negative breast cancer TNBC hormone receptor positive HR breast cancer recurrent platinum sensitive ovarian cancer urothelial cancer UC and castration resistant prostate cancer CRPC
Detailed Description:
Avelumab is a human immunoglobulin IgG1 monoclonal antibody mAb directed against programmed death ligand 1 PD L1 Avelumab selectively binds to PD L1 and competitively blocks its interaction with programmed death receptor 1 PD 1 thereby interfering with this key immune checkpoint inhibition pathway Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies
Talazoparib is a potent orally bioavailable poly adenosine diphosphate ADP ribose polymerase PARP inhibitor which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid DNA repair an effect referred to as synthetic lethality and by trapping PARP protein on DNA thereby preventing DNA repair replication and transcription
Avelumab in combination with talazoparib will be investigated in patients with locally advanced primary or recurrent or metastatic solid tumors including non-small cell lung cancer NSCLC triple negative breast cancer TNBC hormone receptor positive HR breast cancer recurrent platinum sensitive ovarian cancer urothelial cancer UC and castration resistant prostate cancer CRPC
Talazoparib is a potent orally bioavailable poly adenosine diphosphate ADP ribose polymerase PARP inhibitor which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid DNA repair an effect referred to as synthetic lethality and by trapping PARP protein on DNA thereby preventing DNA repair replication and transcription
Avelumab in combination with talazoparib will be investigated in patients with locally advanced primary or recurrent or metastatic solid tumors including non-small cell lung cancer NSCLC triple negative breast cancer TNBC hormone receptor positive HR breast cancer recurrent platinum sensitive ovarian cancer urothelial cancer UC and castration resistant prostate cancer CRPC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001509-33 | EUDRACT_NUMBER | None | None |
| JAVELIN PARP MEDLEY | OTHER | Alias Study Number | None |