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
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
1 other identifier
interventional
36
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started Apr 2012
Shorter than P25 for phase_1 cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 10, 2016
October 1, 2016
1.2 years
December 9, 2011
October 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the impact of custirsen on paclitaxel pharmacokinetics
The maximum peak concentration of paclitaxel after administration.
0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
Secondary Outcomes (1)
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
Study Arms (1)
Paclitaxel/carboplatin with custirsen
EXPERIMENTALCustirsen added to standard paclitaxel/carboplatin chemotherapy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2011
First Posted
December 22, 2011
Study Start
April 1, 2012
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
October 10, 2016
Record last verified: 2016-10