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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 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: March 15, 2013
Last verified: March 2013
History of Changes

April 30, 2012
March 15, 2013
June 2012
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01589419 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 approximatly 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 ]
Not Provided
Not Provided
 
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)

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).
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Locally Advanced Rectal Cancer
  • Drug: veliparib
    see arm description
    Other Name: ABT-888
  • Drug: capecitabine
    see arm description
    Other Name: Xeloda
  • Radiation: radiation
    see arm description
Experimental: veliparib and capecitabine and radiation
Veliparib on days 1-7, capecitabine and radiation on days 1-5
Interventions:
  • Drug: veliparib
  • Drug: capecitabine
  • Radiation: radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
36
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT01589419
M12-950
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Kyle Holen, MD AbbVie
AbbVie
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP