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

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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

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

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Veliparib Drug: Gemcitabine Radiation: Intensity modulated radiation therapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2, 2013
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 6, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination: veliparib, gemcitabine, and IMRT Drug: Veliparib
Other Name: ABT-888

Drug: Gemcitabine
Other Name: Gemzar

Radiation: Intensity modulated radiation therapy



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. Evaluation of pre-treatment biopsy specimens for levels of various DNA repair proteins [ Time Frame: Baseline only ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908478


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
AbbVie
Investigators
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Principal Investigator: Richard Tuli, MD Cedars-Sinai Medical Center
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Responsible Party: Richard Tuli, MD, Assistant Professor, Radiation Oncology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01908478    
Other Study ID Numbers: IIS-ABT888-0002
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Tuli, MD, Cedars-Sinai Medical Center:
locally advanced
unresectable
pancreatic
pancreas
pancreatic adenocarcinoma
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Veliparib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors