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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

To evaluate the impact of custirsen on paclitaxel pharmacokinetics

Outcome Description:

The maximum peak concentration of paclitaxel after administration.

Outcome 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

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

TV1011-DDI-105

NCT ID:

NCT01497470

Start Date:

April 2012

Completion Date:

April 2013

Related Keywords:

  • Cancer
  • paclitaxel
  • carboplatin
  • custirsen
  • drug-drug interaction
  • pharmacokinetics
  • cancer

Name

Location

Teva Investigational Site 002Detroit, Michigan  
Teva Investigational Site 001Dallas, Texas  
Teva Investigational Site 003San Antonio, Texas  
Teva Investigational Site 004Tacoma, Washington