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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497470
• Other study ID #: TV1011-DDI-105
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2011
• Last updated: October 7, 2016
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2016
• Source: OncoGenex Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
OncoGenex Technologies	Teva Pharmaceutical Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes