A Clinical Study Conducted in Multiple Centers Evaluating Escalating Doses of Veliparib in Combination With Capecitabine and Radiation in Patients With Locally Advanced Rectal Cancer
Phase 1
Completed
- Conditions
- Locally Advanced Rectal Cancer
- Interventions
- Registration Number
- NCT01589419
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description veliparib and capecitabine and radiation radiation Veliparib on days 1-7, capecitabine and radiation on days 1-5 veliparib and capecitabine and radiation capecitabine Veliparib on days 1-7, capecitabine and radiation on days 1-5 veliparib and capecitabine and radiation veliparib Veliparib on days 1-7, capecitabine and radiation on days 1-5
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD) 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).
- Secondary Outcome Measures
Name Time Method Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib Multiple measurements over time points (0, .5, 1, 2, 3, 4, 6 hours post dose) Day 1, Day 2 and at the pre-dose time point on Day 5 and week 2 visit. Assess the safety (number of participants with adverse events and types of adverse events observed) From screening and ongoing at each weekly treatment visit through dosing period (anticipated to be approximately 5 weeks), prior to surgery and at the final visit. Assess the tolerability (number of participants with adverse events and types of adverse events observed) From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).
Trial Locations
- Locations (6)
Site Reference ID/Investigator# 99095
🇺🇸Scottsdale, Arizona, United States
Site Reference ID/Investigator# 68045
🇺🇸Durham, North Carolina, United States
Site Reference ID/Investigator# 67882
🇦🇺East Melbourne, Australia
Site Reference ID/Investigator# 68044
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 68043
🇺🇸Madison, Wisconsin, United States
Site Reference ID/Investigator# 112395
🇺🇸Goshen, Indiana, United States