Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Pancreatic Cancer (VelGemRad)

• ClinicalTrials.gov Identifier: NCT01908478
• Recruitment Status: Completed
• First Posted: July 25, 2013
• Last Update Posted: July 15, 2020
• Sponsor: Cedars-Sinai Medical Center
• Collaborator: AbbVie
• Information provided by (Responsible Party): Richard Tuli, MD, Cedars-Sinai Medical Center

Tracking Information

• First Submitted Date: July 18, 2013
• First Posted Date: July 25, 2013
• Last Update Posted Date: July 15, 2020
• Actual Study Start Date: October 2, 2013
• Actual Primary Completion Date: July 14, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 23, 2013): Maximum-tolerated dose (MTD) of veliparib based on the incidence of dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: Days 1-70 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 23, 2013)

• Assessment of objective response rates measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: From baseline to Week 26 ]
  Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response
• Evaluation of pre-treatment biopsy specimens for levels of various DNA repair proteins [ Time Frame: Baseline only ]
• Change in PAR [Poly(ADP-ribosyl)ation] levels in peripheral blood mononuclear cells [ Time Frame: Baseline, Weekly for 6 weeks, and at Weeks 10, 18, and 26 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Pancreatic Cancer
• Official Title: A Phase I Study of Veliparib (ABT-888) in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer

Brief Summary

This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic Cancer.

Primary Objectives:

• Determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer.
• Determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer

• Detailed Description: Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a dose escalation schema. The starting dose of veliparib is 20 mg BID based upon safety/efficacy data available. Dose escalation will continue in 20 mg increments until the maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer

Intervention

• Drug: Veliparib
  Other Name: ABT-888
• Drug: Gemcitabine
  Other Name: Gemzar
• Radiation: Intensity modulated radiation therapy

Study Arms

Experimental: Combination: veliparib, gemcitabine, and IMRT

Interventions:

• Drug: Veliparib
• Drug: Gemcitabine
• Radiation: Intensity modulated radiation therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 25, 2016): 34
• Original Estimated Enrollment (submitted: July 23, 2013): 30
• Actual Study Completion Date: July 6, 2020
• Actual Primary Completion Date: July 14, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.
• Age 18 years or older

Exclusion Criteria:

• Patients who have had prior anti-cancer treatment for their disease
• Patients who are currently receiving any other investigational agents
• Metastatic disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP [Poly (ADP-ribosome) polymerase] inhibitors or gemcitabine
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01908478
• Other Study ID Numbers: IIS-ABT888-0002
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Richard Tuli, MD, Cedars-Sinai Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Cedars-Sinai Medical Center
• Original Study Sponsor: Same as current
• Collaborators: AbbVie

Investigators

• Principal Investigator: Richard Tuli, MD; Cedars-Sinai Medical Center

• PRS Account: Cedars-Sinai Medical Center
• Verification Date: July 2020