Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01589419




Registration number
NCT01589419
Ethics application status
Date submitted
30/04/2012
Date registered
2/05/2012
Date last updated
20/11/2017

Titles & IDs
Public title
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
Scientific 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)
Secondary ID [1] 0 0
M12-950
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Rectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - veliparib
Treatment: Drugs - capecitabine
Treatment: Other - radiation

Experimental: veliparib and capecitabine and radiation - Veliparib on days 1-7, capecitabine and radiation on days 1-5


Treatment: Drugs: veliparib
see arm description

Treatment: Drugs: capecitabine
see arm description

Treatment: Other: radiation
see arm description
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
Timepoint [1] 0 0
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 outcome [1] 0 0
Assess the safety (number of participants with adverse events and types of adverse events observed)
Timepoint [1] 0 0
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 outcome [2] 0 0
Assess the tolerability (number of participants with adverse events and types of adverse events observed)
Timepoint [2] 0 0
From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).
Secondary outcome [3] 0 0
Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib
Timepoint [3] 0 0
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.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 67882 - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01589419
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Philip Komarnitsky, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01589419