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

Sponsor

Achieve Life Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT01497470

Collaborator

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Custirsen, paclitaxel and carboplatin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

An Open-Label, One-Arm, One-Sequence Crossover Drug-Drug Interaction Study in Advanced Solid Tumor Subjects Subjects to Evaluate the Potential Effect of Custirsen (OGX-011) on the Pharmacokinetics of Paclitaxel

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paclitaxel/carboplatin with custirsen Custirsen added to standard paclitaxel/carboplatin chemotherapy	Drug: 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

Arm

Intervention/Treatment

Experimental: Paclitaxel/carboplatin with custirsen

Custirsen added to standard paclitaxel/carboplatin chemotherapy

Drug: 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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Teva Investigational Site 002	Detroit	Michigan	United States
2	Teva Investigational Site 001	Dallas	Texas	United States
3	Teva Investigational Site 003	San Antonio	Texas	United States
4	Teva Investigational Site 004	Tacoma	Washington	United States