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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.
Sponsor:
Collaborator:
OncoGenex Technologies
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01497470
First received: December 9, 2011
Last updated: October 18, 2013
Last verified: October 2013

December 9, 2011
October 18, 2013
April 2012
July 2013   (final data collection date for primary outcome measure)
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.
  • Paclitaxel Maximum Observed Plasma Concentration (Cmax) [ 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 ]
    Paclitaxel Cmax on Period 3 (test treatment) vs. Paclitaxel Cmax on Period 1 (reference treatment)
  • Paclitaxel Area Under the Curve from Time Zero to Last Quantifiable Concentration [AUC(0-t)] [ 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 ]
    Paclitaxel AUC(0-t) on Period 3 (test treatment) vs. Paclitaxel AUC(0-t) on Period 1 (reference treatment)
  • Paclitaxel Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-∞)] [ 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 ]
    Paclitaxel AUC(0-∞) on Period 3 (test treatment) vs. Paclitaxel AUC(0-∞) on Period 1 (reference treatment)
Complete list of historical versions of study NCT01497470 on ClinicalTrials.gov Archive Site
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 ]
  • Carboplatin Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 2.83, 4.83, 8.83 and 20.83 hours after the start of carboplatin infusion ] [ Designated as safety issue: No ]
    Carboplatin Cmax on Period 3 (test treatment) vs. Carboplatin Cmax on Period 1 (reference treatment)
  • Carboplatin Area Under the Curve from Time Zero to Last Quantifiable Concentration [AUC(0-t)] [ Time Frame: 0, 0.5, 2.83, 4.83, 8.83 and 20.83 hours after the start of carboplatin infusion ] [ Designated as safety issue: No ]
    Carboplatin AUC(0-t) on Period 3 (test treatment) vs. carboplatin AUC(0-t) on Period 1 (reference treatment)
  • Custirsen Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 2, 3.17, 4.17, 5.17, 8.17, 14.17, 26.17 and 50.17 hours after the start of custirsen infusion ] [ Designated as safety issue: No ]
    Custirsen Cmax on Period 3 (test treatment)
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Cancer
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
Experimental: Pacitaxel/carboplatin with custirsen
Custirsen added to standard paclitaxel/carboplatin chemotherapy
Intervention: Drug: Custirsen, paclitaxel and carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01497470
TV1011-DDI-105
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
OncoGenex Technologies
Not Provided
Teva Pharmaceutical Industries
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP