Clinical trial NCT01063816: A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
Official title: A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: PARP Inhibitors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Determine the maximum tolerated dose and recommended Phase 2 dose
timeFrame: 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:
measure: Pharmacokinetics Area Under the Curve (AUC)
timeFrame: 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
measure: Safety assessment: Electrocardiogram
timeFrame: Screening, Day 8 of each Cycle of drug and Final Visit
measure: Safety assessment: Clinical Laboratory Tests
timeFrame: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
measure: Physical exam including vital signs
timeFrame: Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit
measure: Safety assessment: Adverse event assessments
timeFrame: All study visits
measure: Tumor assessment
timeFrame: Screening, every nine weeks and Final Visit
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Mark D McKee, MD
role: STUDY_DIRECTOR
References:
citation: 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.