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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)


Phase 1
18 Years
N/A
Open (Enrolling by invite only)
Both
Locally Advanced Rectal Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)

Outcome 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).

Safety Issue:

Yes

Principal Investigator

Kyle Holen, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

M12-950

NCT ID:

NCT01589419

Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Locally Advanced Rectal Cancer
  • DLT
  • radiation
  • veliparib
  • locally advanced rectal cancer
  • ABT-888
  • capecitabine
  • MTD
  • PARP
  • Rectal Neoplasms

Name

Location

Site Reference ID/Investigator# 68044 Chicago, Illinois  60611
Site Reference ID/Investigator# 68045 Durham, North Carolina  27710
Site Reference ID/Investigator# 99095 Scottsdale, Arizona  85258
Site Reference ID/Investigator# 68043 Madison, Wisconsin  53792