NCT01908478

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 2, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

July 18, 2013

Last Update Submit

July 13, 2020

Conditions

Pancreatic Cancer

Keywords

locally advancedunresectablepancreaticpancreaspancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (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)

    Days 1-70

Secondary Outcomes (3)

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

    From baseline to Week 26

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

    Baseline only

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

    Baseline, Weekly for 6 weeks, and at Weeks 10, 18, and 26

Study Arms (1)

Combination: veliparib, gemcitabine, and IMRT

EXPERIMENTAL
Drug: VeliparibDrug: GemcitabineRadiation: Intensity modulated radiation therapy

Interventions

VeliparibDRUG
Also known as: ABT-888
Combination: veliparib, gemcitabine, and IMRT
GemcitabineDRUG
Also known as: Gemzar
Combination: veliparib, gemcitabine, and IMRT
Intensity modulated radiation therapyRADIATION
Combination: veliparib, gemcitabine, and IMRT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

veliparibGemcitabineRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Richard Tuli, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Radiation Oncology

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 25, 2013

Study Start

October 2, 2013

Primary Completion

July 14, 2017

Study Completion

July 6, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations

US(1)