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

Locally Advanced Rectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589419
• Other study ID #: M12-950
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2012
• Last updated: November 16, 2017
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• veliparib
see arm description
• capecitabine
see arm description

Radiation:
• radiation
see arm description

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 67882	East Melbourne
United States	Site Reference ID/Investigator# 68044	Chicago	Illinois
United States	Site Reference ID/Investigator# 68045	Durham	North Carolina
United States	Site Reference ID/Investigator# 112395	Goshen	Indiana
United States	Site Reference ID/Investigator# 68043	Madison	Wisconsin
United States	Site Reference ID/Investigator# 99095	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (1)

Czito 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)		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	Assess the safety (number of participants with adverse events and types of adverse events observed)		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.
Secondary	Assess the tolerability (number of participants with adverse events and types of adverse events observed)		From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).
Secondary	Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib		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.