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Metastatic Pancreatic CancerPhase 1/2NCT01489865

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

A Phase 1/2 study testing ABT-888 and mFOLFOX-6 in people with Metastatic Pancreatic Cancer, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
ABT-888 and mFOLFOX-6
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
3 Jan 2011to 7 Dec 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 1st, 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
  • Age >= 18 years
  • ECOG performance status 0-2
  • Subjects with no brain metastases or a history of previously treated brain metastases who have been treated with surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of intercranial disease and have not had treatment with steroids within 1 week of study enrollment.
  • Subjects may have received any number of prior therapies except prior therapy with a PARP inhibitor
  • At least 14 days must have passed since all prior anti-cancer therapy
  • At least 28 days must have passed since any prior antibody-based therapies
  • At least 28 days must have passed since any prior investigational agent
  • All patients must have completely recovered from all transient side effects related to prior therapies and any side effects that are expected to be more durable or permanent must have resolved to Grade 1
  • Adequate hepatic, bone marrow and renal function
  • Partial thromboplastin time must be </= 2 X upper limit of institution's normal range and INR < 2. Subjects on an anticoagulant must have a PTT </= 5 X upper limit of institution's normal range and INR < 5.
  • Life expectancy > 12 weeks
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment
  • Subject must be capable of understanding and complying with parameters as outlined in protocol and able to sign and date the informed consent form
  • Patients must have fully recovered from all effects of surgery.

Who cannot join

  • 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.
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  • Active uncontrolled infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Psychiatric illness/ social situation that would limit compliance with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer

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.

Read the detailed description

This is a single arm, open-label Phase I/II study to evaluate the clinical activity of the novel inhibitor of Poly(ADP-ribose) polymerase (PARP), ABT-888 with modified FOLFOX-6 (5-Fluorouracil plus oxaliplatin) in patients with metastatic pancreatic cancer.

Being tested
ABT-888, mFOLFOX-6
Keywords
Pancreas cancer, Veliparib, oxaliplatin
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-888Drug

    Also called veliparib

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

  • mFOLFOX-6Drug

    Also called 5-Fluorouracil, Eloxatin

    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

Study groups in NCT01489865
Study groupRoleWhat they receive
Phase 1: ABT-888 40mg (Cohort 1)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 60 mg (Cohort 2)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 80 mg (Cohort 3)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 100 mg (Cohort 4)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 150 mg (Cohort 5)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 200 mg (Cohort 6)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 250 mg (Cohort 7)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 1: ABT-888 300 mg (Cohort 8)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6
Phase 2: ABT-888 at Recommended phase 2 dose (200mg)ExperimentalABT-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
Receives: Drug: ABT-888; Drug: mFOLFOX-6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 28 days

  2. 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.

    Measured: 6 months

Secondary outcomes (3)

  1. Disease Control Rate (DCR)

    DCR is defined as the number of patients with a complete response, partial response, or stable disease at 6 months per Recist 1.1.

    Measured: 6 months

  2. Progression Free Survival (PFS)

    PFS is defined as the number of days from enrollment to progression or death, whichever occurred first.

    Measured: up to 114 months

  3. Overall Survival

    The number of days from enrollment until death or last contact. Patients who were alive at the time of analysis were censored at their last contact.

    Measured: up to 114 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2011 (estimated)
  2. Study start3 Jan 2011
  3. Primary completion26 Dec 2018
  4. Study completion7 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01489865
Sponsor's protocol ID
LCCC 2009-608
Status last verified
Oct 2025
First submitted
8 Dec 2011
Last updated
6 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABT-888 and mFOLFOX-6 in people with Metastatic Pancreatic Cancer, run by Georgetown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Number of Dose Limiting Toxicities (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

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