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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

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: April 30, 2012
Last updated: January 20, 2015
Last verified: January 2015
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).

Condition Intervention Phase
Locally Advanced Rectal Cancer
Drug: veliparib
Drug: capecitabine
Radiation: radiation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD) [ 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). ]

Secondary Outcome Measures:
  • Assess the safety (number of participants with adverse events and types of adverse events observed) [ Time Frame: 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) [ Time Frame: From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks). ]
  • Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib [ Time Frame: 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. ]

Enrollment: 32
Study Start Date: June 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: veliparib and capecitabine and radiation
Veliparib on days 1-7, capecitabine and radiation on days 1-5
Drug: veliparib
see arm description
Other Name: ABT-888
Drug: capecitabine
see arm description
Other Name: Xeloda
Radiation: radiation
see arm description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01589419

United States, Arizona
Site Reference ID/Investigator# 99095
Scottsdale, Arizona, United States, 85258
United States, Illinois
Site Reference ID/Investigator# 68044
Chicago, Illinois, United States, 60611
United States, Indiana
Site Reference ID/Investigator# 112395
Goshen, Indiana, United States, 46526
United States, North Carolina
Site Reference ID/Investigator# 68045
Durham, North Carolina, United States, 27710
United States, Wisconsin
Site Reference ID/Investigator# 68043
Madison, Wisconsin, United States, 53792
Site Reference ID/Investigator# 67882
East Melbourne, Australia, 3002
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Philip Komarnitsky, MD AbbVie
  More Information

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01589419     History of Changes
Other Study ID Numbers: M12-950
Study First Received: April 30, 2012
Last Updated: January 20, 2015

Keywords provided by AbbVie:
locally advanced rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017