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

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Veliparib

Gemcitabine

Intensity modulated radiation therapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring locally advanced, unresectable, pancreatic, pancreas, pancreatic adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination: veliparib, gemcitabine, and IMRT

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Assessment of objective response rates measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

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

Change in PAR [Poly(ADP-ribosyl)ation] levels in peripheral blood mononuclear cells

Full Information

NCT ID

NCT01908478

First Posted

July 18, 2013

Last Updated

July 13, 2020

Sponsor

Cedars-Sinai Medical Center

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT01908478

Brief Title

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

Acronym

VelGemRad

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 2, 2013 (Actual)

Primary Completion Date

July 14, 2017 (Actual)

Study Completion Date

July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

locally advanced, unresectable, pancreatic, pancreas, pancreatic adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination: veliparib, gemcitabine, and IMRT

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Veliparib

Other Intervention Name(s)

ABT-888

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Type

Radiation

Intervention Name(s)

Intensity modulated radiation therapy

Primary Outcome Measure Information:

Title

Time Frame

Days 1-70

Secondary Outcome Measure Information:

Title

Assessment of objective response rates measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Description

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

Time Frame

From baseline to Week 26

Title

Evaluation of pre-treatment biopsy specimens for levels of various DNA repair proteins

Time Frame

Baseline only

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Tuli, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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