An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC)
18 Years
N/A
Both
Locally Advanced Rectal Cancer
Trial Information
An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC)
Inclusion Criteria:
- Subject must be ≥ 18 years of age
- All subjects must have newly diagnosed, histologically proven adenocarcinoma of the
rectum
- All subjects must have an abdominal/pelvis computed tomography (CT ) scan or magnetic
resonance imaging (MRI) confirming no evidence of distant metastases
- Distal border of tumor < 12 cm from anal verge
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of
0 to 2
- No prior treatment for LARC however prior treatments for other cancers are acceptable
as long as they are considered curative
Exclusion Criteria:
- Subject is an unsuitable candidate for TME surgery
- Subject has received anticancer therapy
- Subject has received prior radiation therapy
- Subject has had major surgery within 28 days prior to the first dose of study drug
- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that
might interfere with gastrointestinal motility, pH or absorption
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
Outcome Time Frame:
From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks).
Safety Issue:
Yes
Principal Investigator
Kyle Holen, MD
Investigator Role:
Study Director
Investigator Affiliation:
AbbVie
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
M12-950
NCT ID:
NCT01589419
Start Date:
June 2012
Completion Date:
June 2015
Related Keywords:
- Locally Advanced Rectal Cancer
- DLT
- radiation
- veliparib
- locally advanced rectal cancer
- ABT-888
- capecitabine
- MTD
- PARP
- Rectal Neoplasms
Name | Location |
|---|---|
| Site Reference ID/Investigator# 68044 | Chicago, Illinois 60611 |
| Site Reference ID/Investigator# 68045 | Durham, North Carolina 27710 |
| Site Reference ID/Investigator# 99095 | Scottsdale, Arizona 85258 |
| Site Reference ID/Investigator# 68043 | Madison, Wisconsin 53792 |
