NCT01063816

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

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

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

6.6 years

First QC Date

February 4, 2010

Last Update Submit

July 29, 2021

Conditions

Advanced Solid Tumors

Keywords

PARP Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose and recommended Phase 2 dose

    ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).

Secondary Outcomes (6)

  • Pharmacokinetics Area Under the Curve (AUC)

    Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose

  • Safety assessment: Electrocardiogram

    Screening, Day 8 of each Cycle of drug and Final Visit

  • Safety assessment: Clinical Laboratory Tests

    Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit

  • Physical exam including vital signs

    Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit

  • Safety assessment: Adverse event assessments

    All study visits

  • +1 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: veliparib (ABT-888)Drug: carboplatinDrug: gemcitabine

Interventions

veliparib (ABT-888)DRUG

Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.

Arm 1
carboplatinDRUG

Carboplatin will be dosed on Day 1 of each cycle, intravenously.

Arm 1
gemcitabineDRUG

Dosing on Days 1 and 8 of each Cycle, intravenously.

Also known as: Gemzar
Arm 1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
  • Eastern Cooperative Group performance score of 0 to 2.
  • Adequate hematologic, hepatic and renal function
  • Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years

You may not qualify if:

  • Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
  • Subjects with known history of brain metastases and primary CNS tumors.
  • Hypersensitivity reactions to platinum compounds or gemcitabine.
  • Clinically significant and uncontrolled major medical conditions
  • Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gray HJ, Bell-McGuinn K, Fleming GF, Cristea M, Xiong H, Sullivan D, Luo Y, McKee MD, Munasinghe W, Martin LP. Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies. Gynecol Oncol. 2018 Mar;148(3):507-514. doi: 10.1016/j.ygyno.2017.12.029. Epub 2018 Jan 17.

    PMID: 29352572BACKGROUND

Related Links

MeSH Terms

Interventions

veliparibCarboplatinGemcitabine

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Mark D McKee, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 2, 2021

Record last verified: 2021-07