A Study of Veliparib in Combination With Carboplatin and Paclitaxel in Japanese Subjects With Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01617928
First received: May 23, 2012
Last updated: February 28, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: veliparib (ABT-888) Drug: carboplatin Drug: paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Veliparib (ABT-888) in Combination With Carboplatin/Paclitaxel in Japanese Subjects With Solid Tumors |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Determine the maximum tolerated dose and recommended Phase two dose [ Time Frame: During the first cycle (21 days from first dose of veliparib) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) [ Time Frame: Eight timepoints on Day 1 of first cycle (21 days) ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Eight timepoints on Day 3 of first cycle (21 days) ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Eight timepoints on Day 3 of first cycle (21 days) ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Six timepoints on Day 3 of first cycle (21 days) ] [ Designated as safety issue: No ]
- Preliminary tumor response [ Time Frame: 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. ] [ Designated as safety issue: No ]Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
- Safety assessment; Physical exam including vital signs [ Time Frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) ] [ Designated as safety issue: Yes ]Blood pressure, pulse and body temperature
- Safety assessment; Clinical lab testings [ Time Frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) ] [ Designated as safety issue: Yes ]Hematology, Chemistry and Urinalysis
- Safety assessment; Adverse event monitoring [ Time Frame: From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) ] [ Designated as safety issue: Yes ]Collect all adverse events at each visit
- Safety assessment; Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Day 8 of first cycle (21 days) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: veliparib (ABT-888) |
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.
Drug: carboplatin
Carboplatin will be administered on Day 3 of each cycle, intravenously.
Other Name: paraplatin
Drug: paclitaxel
Paclitaxel will be administered on Day 3 of each cycle, intravenously.
Other Name: taxol
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01617928 History of Changes |
| Other Study ID Numbers: | M12-629 |
| Study First Received: | May 23, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Neoplasms Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013