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 is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01589419
First received: April 30, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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). ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]
  • 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). ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01589419

Locations
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
Australia
Site Reference ID/Investigator# 67882
East Melbourne, Australia, 3002
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Kyle Holen, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01589419     History of Changes
Other Study ID Numbers: M12-950
Study First Received: April 30, 2012
Last Updated: May 19, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by AbbVie:
DLT
radiation
veliparib
locally advanced rectal cancer
ABT-888
capecitabine
MTD
PARP

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014