ABT-888 With Modified FOLFOX6 in Patients With Metastatic Pancreatic Cancer

NCT01489865 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: LCCC 2009-608
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreas cancer; Veliparib; oxaliplatin

Outcome Measures

Primary Outcomes (2)

• Phase 1: Number of Dose Limiting Toxicities

  Protocol defined events that are definitely, possibly or probably related to one or both agents and have occurred in the first cycle of therapy. Applies only to patients in the Phase I portion of the study.

  28 days

• Phase II: Objective Response Rate (ORR)

  Number of Participants in Phase II with a Complete response and Partial response as determined by RECIST 1.1.

  6 months

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  6 months

• Progression Free Survival (PFS)

  up to 114 months

• Overall Survival

  up to 114 months

Study Arms (9)

Phase 1: ABT-888 40mg (Cohort 1)

EXPERIMENTAL

ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 60 mg (Cohort 2)

EXPERIMENTAL

ABT-888 orally at 60mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 80 mg (Cohort 3)

EXPERIMENTAL

ABT-888 orally at 80mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 100 mg (Cohort 4)

EXPERIMENTAL

ABT-888 orally at 100mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 150 mg (Cohort 5)

EXPERIMENTAL

ABT-888 orally at 150mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 200 mg (Cohort 6)

EXPERIMENTAL

ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 250 mg (Cohort 7)

EXPERIMENTAL

ABT-888 orally at 250mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 1: ABT-888 300 mg (Cohort 8)

EXPERIMENTAL

ABT-888 orally at 300mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Phase 2: ABT-888 at Recommended phase 2 dose (200mg)

EXPERIMENTAL

ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Drug: ABT-888; Drug: mFOLFOX-6

Interventions

ABT-888 DRUG

ABT-888 in escalating doses twice a day for Days 1-7 of each 14-day cycle

Also known as: veliparib

Phase 1: ABT-888 100 mg (Cohort 4); Phase 1: ABT-888 150 mg (Cohort 5); Phase 1: ABT-888 200 mg (Cohort 6); Phase 1: ABT-888 250 mg (Cohort 7); Phase 1: ABT-888 300 mg (Cohort 8); Phase 1: ABT-888 40mg (Cohort 1); Phase 1: ABT-888 60 mg (Cohort 2); Phase 1: ABT-888 80 mg (Cohort 3); Phase 2: ABT-888 at Recommended phase 2 dose (200mg)

mFOLFOX-6 DRUG

Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3

Also known as: 5-Fluorouracil, Eloxatin

Phase 1: ABT-888 100 mg (Cohort 4); Phase 1: ABT-888 150 mg (Cohort 5); Phase 1: ABT-888 200 mg (Cohort 6); Phase 1: ABT-888 250 mg (Cohort 7); Phase 1: ABT-888 300 mg (Cohort 8); Phase 1: ABT-888 40mg (Cohort 1); Phase 1: ABT-888 60 mg (Cohort 2); Phase 1: ABT-888 80 mg (Cohort 3); Phase 2: ABT-888 at Recommended phase 2 dose (200mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven pancreatic adenocarcinoma with measurable disease
• A known BRCA-associate genetic mutation OR family history suggesting of a breast or ovarian cancer syndrome, as defined by one or more of the following:
• Personal or known family history of a deleterious (or indeterminate) mutation in the BRCA1, BRCA2, PALBB2, or one of the FANC genes.
• Personal history of breast cancer and one or more of the following:
• Diagnosed ≤ 45 years old
• Diagnosed at any age with ≥1 1st, 2nd, or 3rd degree relative with breast cancer ≤ 50 years old and/or ≥1st, 2nd, or 3rd relative with epithelial ovarian cancer at any age
• Two primary breast cancer with the first diagnosed at ≤ 50 years old
• Diagnosed ≤ 60 years old with triple negative breast cancer
• Diagnosed at any age with ≥2 1st, 2nd, or 3rd degree relatives with breast cancer at any age
• Diagnosed at any age with ≥2 1st, 2nd, or 3rd degree relatives with pancreatic cancer or aggressive prostate cancer (Gleason score ≥7) at any age
• st, 2nd, or 3rd degree male relative with breast cancer
• Ashkenazi Jewish descent
• Personal history of epithelial ovarian cancer
• Personal history of male breast cancer
• Personal history of pancreatic cancer and ≥2 1st, 2nd, or 3rd degree relatives with breast, epitherlial ovarian, pancreatic, or aggressive prostate cancer (Gleason score ≥7) at any age

You may not qualify if:

• Active severe infection, or known chronic infection with HIV, Hepatitis B virus or Hepatitis C virus
• Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
• Life-threatening visceral disease or other severe concurrent disease
• Women who are pregnant or breast-feeding
• Anticipated survival under 3 months
• The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder, or non-melanoma carcinoma of the skin.
• Active uncontrolled infection
• Symptomatic congestive heart failure
• Unstable angina pectoris or cardiac arrhythmia
• Psychiatric illness/ social situation that would limit compliance with study requirements

Sponsors & Collaborators

• Georgetown University: lead
• Abbott: collaborator

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

veliparib; Fluorouracil; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Benjamin Weinberg, MD
• Organization: Lombardi Comprehensive Cancer Center

baw12@gunet.georgetown.edu

202-444-2223

Study Officials

• Michael Pishvaian, MD PhD

  Johns Hopkins University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 12, 2011
• Study Start: January 3, 2011
• Primary Completion: December 26, 2018
• Study Completion: December 7, 2023
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)