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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01908478
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Richard Tuli, MD, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE July 25, 2013
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE October 2, 2013
Actual Primary Completion Date July 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Pancreatic Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Veliparib
    Other Name: ABT-888
  • Drug: Gemcitabine
    Other Name: Gemzar
  • Radiation: Intensity modulated radiation therapy
Study Arms  ICMJE Experimental: Combination: veliparib, gemcitabine, and IMRT
Interventions:
  • Drug: Veliparib
  • Drug: Gemcitabine
  • Radiation: Intensity modulated radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2016)
34
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2013)
30
Actual Study Completion Date  ICMJE July 6, 2020
Actual Primary Completion Date July 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01908478
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Current Responsible Party Richard Tuli, MD, Cedars-Sinai Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cedars-Sinai Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE AbbVie
Investigators  ICMJE
Principal Investigator: Richard Tuli, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP