A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617928
• Other study ID #: M12-629
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: November 16, 2017
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed malignant solid tumor.

• Patients who are amenable to standard combination chemotherapy of carboplatin and paclitaxel.

• Patients should have received less than or equal to 1 prior chemotherapy regimens for advanced stage disease.

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

• Patients must have normal organ and marrow function

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the adverse events due to agents administered more than 3 weeks earlier have not recovered to less than grade 2.

• Known history of allergic reactions to carboplatin or cremophor-paclitaxel.

• Patients who have previously received a poly(ADP-ribose) polymerase (PARP) inhibitor.

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection requiring treatment, symptomatic congestive heart failure, angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• History of seizure disorder.

• Hepatitis B surface antigen (HBsAg) positive, Hepatitis C virus (HCV) antibody positive or Human immunodeficiency virus (HIV)-positive patients.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• veliparib (ABT-888)
Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.
• carboplatin
Carboplatin will be administered on Day 3 of each cycle, intravenously.
• paclitaxel
Paclitaxel will be administered on Day 3 of each cycle, intravenously.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 68622	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Mizugaki H, Yamamoto N, Nokihara H, Fujiwara Y, Horinouchi H, Kanda S, Kitazono S, Yagishita S, Xiong H, Qian J, Hashiba H, Shepherd SP, Giranda V, Tamura T. A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximum tolerated dose and recommended Phase two dose		During the first cycle (21 days from first dose of veliparib)
Secondary	Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888)		Eight timepoints on Day 1 of first cycle (21 days)
Secondary	Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel		Eight timepoints on Day 3 of first cycle (21 days)
Secondary	Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of paclitaxel when administered in combination with veliparib (ABT-888) and carboplatin		Eight timepoints on Day 3 of first cycle (21 days)
Secondary	Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of carboplatin when administered in combination with veliparib (ABT-888) and paclitaxel		Six timepoints on Day 3 of first cycle (21 days)
Secondary	Preliminary tumor response	Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden	From date of first dose of veliparib until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 6 cycles.
Secondary	Safety assessment; Physical exam including vital signs	Blood pressure, pulse and body temperature	From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Secondary	Safety assessment; Clinical lab testings	Hematology, Chemistry and Urinalysis	From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Secondary	Safety assessment; Adverse event monitoring	Collect all adverse events at each visit	From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
Secondary	Safety assessment; Change from Baseline in Electrocardiogram (ECG)		Day 8 of first cycle (21 days)