Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
OncoGenex Technologies
Information provided by (Responsible Party):
Teva Pharmaceutical Industries Identifier:
First received: December 9, 2011
Last updated: October 18, 2013
Last verified: October 2013

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 Intervention Phase
Drug: Custirsen, paclitaxel and carboplatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • To evaluate the impact of custirsen on paclitaxel pharmacokinetics [ Time Frame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: April 2012
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pacitaxel/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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01497470

United States, Michigan
Teva Investigational Site 002
Detroit, Michigan, United States
United States, Texas
Teva Investigational Site 001
Dallas, Texas, United States
Teva Investigational Site 003
San Antonio, Texas, United States
United States, Washington
Teva Investigational Site 004
Tacoma, Washington, United States
Sponsors and Collaborators
Teva Pharmaceutical Industries
OncoGenex Technologies
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries Identifier: NCT01497470     History of Changes
Other Study ID Numbers: TV1011-DDI-105
Study First Received: December 9, 2011
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
drug-drug interaction

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on February 27, 2015