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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: Custirsen, paclitaxel and carboplatin

• Registration Number: NCT01497470
• Lead Sponsor: Achieve Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-22
• Study Start: 2012-04
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel/carboplatin with custirsen	Custirsen, paclitaxel and carboplatin	Custirsen added to standard paclitaxel/carboplatin chemotherapy

Primary Outcome Measures

Name	Time	Method
To evaluate the impact of custirsen on paclitaxel pharmacokinetics	0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion	The maximum peak concentration of paclitaxel after administration.

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy	0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion

Trial Locations

Locations (4)

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