A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment Regimen

NCT ID: NCT01497470

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-10-31

Brief Summary

The primary goal of this study is to determine if custirsen has an effect on the way the body distributes and gets rid of paclitaxel, the standard administered chemotherapy. The study will also evaluate if custirsen influences the way the body distributes and gets rid of carboplatin (another standard administered chemotherapy) and will measure custirsen blood levels in this cancer population. Finally, the study will evaluate the safety and tolerability of adding custirsen to the standard paclitaxel/carboplatin chemotherapy.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Paclitaxel/carboplatin with custirsen

Custirsen added to standard paclitaxel/carboplatin chemotherapy

Group Type: EXPERIMENTAL

Custirsen, paclitaxel and carboplatin

Intervention Type: DRUG

Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle

Interventions

Custirsen, paclitaxel and carboplatin

Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of a solid tumor that is refractory to standard therapies and is not amenable to treatment with established curative or palliative therapies and for whom paclitaxel and carboplatin is deemed an acceptable treatment by the investigator
• Males or females ≥18 years of age
• Life expectancy of ≥12 weeks
• Minimum of 1 lesion
• ECOG performance status of 0, 1 or 2
• Adequate bone marrow reserve
• Adequate renal and liver function

Exclusion Criteria

• Brain metastases that are symptomatic or require ongoing treatment
• Major trauma or surgery within last 2 months, acute infection within 2 weeks (14 days), or radiotherapy, chemotherapy, immunotherapy or hormonal therapy within past 4 weeks
• Persistent grade 2 or greater toxicity related to prior therapy
• Grade 2 or greater peripheral neuropathy
• Recent or current use of Cyp3A4, Cyp2C8 or P-gp inhibitors
• Recent or current use of CYP enzyme inducers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: collaborator

Achieve Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 002

Detroit, Michigan, United States

Teva Investigational Site 001

Dallas, Texas, United States

Teva Investigational Site 003

San Antonio, Texas, United States

Teva Investigational Site 004

Tacoma, Washington, United States

Countries

United States

Other Identifiers

TV1011-DDI-105

Identifier Type: -

Identifier Source: org_study_id