Clinical trial · Interventional
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
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)
NCT01589419CI-TRIAL-00030429completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
| veliparib | Drug | Veliparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- veliparib and capecitabine and radiation
- description
- Veliparib on days 1-7, capecitabine and radiation on days 1-5
- interventionNames
- Drug: veliparib
- Drug: capecitabine
- Radiation: radiation
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
- timeFrame
- 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 outcomes (3)
- measure
- Assess the safety (number of participants with adverse events and types of adverse events observed)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTCzito BG, Deming DA, Jameson GS, Mulcahy MF, Vaghefi H, Dudley MW, Holen KD, DeLuca A, Mittapalli RK, Munasinghe W, He L, Zalcberg JR, Ngan SY, Komarnitsky P, Michael M. Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer: a phase 1b study. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):418-426. doi: 10.1016/S2468-1253(17)30012-2. Epub 2017 Mar 27. PMID 28497757