A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063816
• Other study ID #: M10-758
• Status: Completed
• Phase: Phase 1
• Start date: January 2010
• Est. completion date: August 2016

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• veliparib (ABT-888)
Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.
• carboplatin
Carboplatin will be dosed on Day 1 of each cycle, intravenously.
• gemcitabine
Dosing on Days 1 and 8 of each Cycle, intravenously.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Safety assessment: Electrocardiogram		Screening, Day 8 of each Cycle of drug and Final Visit
Secondary	Safety assessment: Clinical Laboratory Tests	Hematology and Chemistry	Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
Secondary	Physical exam including vital signs	Physical exam including blood pressure, pulse and temperature	Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit
Secondary	Safety assessment: Adverse event assessments	Collect all adverse events at each visit	All study visits
Secondary	Tumor assessment	Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden	Screening, every nine weeks and Final Visit

External Links

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