Clinical trial NCT01617928: A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors
Official title: A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the maximum tolerated dose and recommended Phase two dose
timeFrame: During the first cycle (21 days from first dose of veliparib)
Secondary outcomes:
measure: Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888)
timeFrame: Eight timepoints on Day 1 of first cycle (21 days)
measure: 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
timeFrame: Eight timepoints on Day 3 of first cycle (21 days)
measure: 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
timeFrame: Eight timepoints on Day 3 of first cycle (21 days)
measure: 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
timeFrame: Six timepoints on Day 3 of first cycle (21 days)
measure: Preliminary tumor response
timeFrame: 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.
measure: Safety assessment; Physical exam including vital signs
timeFrame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
measure: Safety assessment; Clinical lab testings
timeFrame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
measure: Safety assessment; Adverse event monitoring
timeFrame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles)
measure: Safety assessment; Change from Baseline in Electrocardiogram (ECG)
timeFrame: Day 8 of first cycle (21 days)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 68622
Study officials:
affiliation: AbbVie
name: Hideyuki Hashiba, BS
role: STUDY_DIRECTOR
References:
citation: 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) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2015 Nov;76(5):1063-72. doi: 10.1007/s00280-015-2876-7. Epub 2015 Oct 3.