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Completed

NCT Number: NCT01589419

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, 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).

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Key information

Conditions

Locally Advanced Rectal Cancer

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 67882, East Melbourne, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veliparib

Drug

see arm description

Other names: ABT-888

Capecitabine

Drug

see arm description

Other names: Xeloda

Radiation

Radiation

see arm description

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 2, 2012
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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