Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01233505
Status:
TERMINATED
Last Update Posted:
2014-04-02
First Post:
2010-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2013-10
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:
This phase I trial is studying the side effects and the best dose of veliparib when given together with capecitabine and oxaliplatin in treating patients with advanced solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of ABT-888 (veliparib) in combination with oxaliplatin and capecitabine in advanced solid tumors.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when administered concomitantly.
II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine and oxaliplatin.
III. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria, in these patients.
TERTIARY OBJECTIVES:
I. To assess the inhibition of poly(ADP-ribose) polymerase (PARP) in peripheral blood mononuclear cells secondary to treatment with ABT-888.
II. To determine the pharmacokinetics of ABT-888 in combination with oxaliplatin and capecitabine and the relation to treatment side effects.
OUTLINE: This is a dose-escalation study of veliparib.
Patients receive veliparib orally (PO) twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin intravenously (IV) over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during study for pharmacokinetic and poly (ADP-ribose) polymerase (PARP) inhibition studies.
After completion of study therapy, patients are followed up for 30 days.
I. To determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of ABT-888 (veliparib) in combination with oxaliplatin and capecitabine in advanced solid tumors.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when administered concomitantly.
II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine and oxaliplatin.
III. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria, in these patients.
TERTIARY OBJECTIVES:
I. To assess the inhibition of poly(ADP-ribose) polymerase (PARP) in peripheral blood mononuclear cells secondary to treatment with ABT-888.
II. To determine the pharmacokinetics of ABT-888 in combination with oxaliplatin and capecitabine and the relation to treatment side effects.
OUTLINE: This is a dose-escalation study of veliparib.
Patients receive veliparib orally (PO) twice daily and capecitabine PO twice daily on 1-7 and 15-21, and oxaliplatin intravenously (IV) over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during study for pharmacokinetic and poly (ADP-ribose) polymerase (PARP) inhibition studies.
After completion of study therapy, patients are followed up for 30 days.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-02543 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000687938 | None | None | View | |
| C010903 | OTHER | University of Wisconsin Hospital and Clinics | View | |
| 8604 | OTHER | CTEP | View | |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062491 | NIH | None | https://reporter.nih.gov/quic… | View |