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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

NCT ID: NCT01589419

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Locally Advanced Rectal Cancer

Keywords

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DLT radiation veliparib locally advanced rectal cancer ABT-888 capecitabine MTD PARP

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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veliparib and capecitabine and radiation

Veliparib on days 1-7, capecitabine and radiation on days 1-5

Group Type EXPERIMENTAL

veliparib

Intervention Type DRUG

see arm description

capecitabine

Intervention Type DRUG

see arm description

radiation

Intervention Type RADIATION

see arm description

Interventions

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veliparib

see arm description

Intervention Type DRUG

capecitabine

see arm description

Intervention Type DRUG

radiation

see arm description

Intervention Type RADIATION

Other Intervention Names

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ABT-888 Xeloda

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Komarnitsky, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 99095

Scottsdale, Arizona, United States

Site Status

Site Reference ID/Investigator# 68044

Chicago, Illinois, United States

Site Status

Site Reference ID/Investigator# 112395

Goshen, Indiana, United States

Site Status

Site Reference ID/Investigator# 68045

Durham, North Carolina, United States

Site Status

Site Reference ID/Investigator# 68043

Madison, Wisconsin, United States

Site Status

Site Reference ID/Investigator# 67882

East Melbourne, , Australia

Site Status

Countries

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United States Australia

References

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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 patients with locally advanced rectal cancer: a phase 1b study. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):418-426. doi: 10.1016/S2468-1253(17)30012-2. Epub 2017 Mar 27.

Reference Type RESULT
PMID: 28497757 (View on PubMed)

Other Identifiers

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M12-950

Identifier Type: -

Identifier Source: org_study_id