A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

NCT00138658 | Completed Phase 1 Results

• 1 other identifier: OGX-011-05
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 15

Brief Summary

This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; custirsen sodium; OGX-011; Stage IIIB or IV advanced non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate of OGX-011 in Combination With Gemcitabine/Platinum-based Regimen

  Per RECIST Criteria V 1.0 and based on radiographic evaluations a subject was defined as having an objective response (OR) if the subject achieved either a confirmed partial response (PR) or confirmed complete response (CR). The evaluations were conducted after every two cycles of treatment for a maximum of 6 cycles. CR: disappearance of clinical/radiological evidence of tumor. PR: \>= 30% decrease in the sum of the longest diameter of target lesions. SD: did not fulfill the criteria for CR or PR but not progressive disease.

  Based on assessments at baseline and after Cycles 2, 4, and 6. All subjects were followed for survival for a minimum of 3 years after the first dose of OGX-011 or until death.

Secondary Outcomes (6)

• Progression-free Survival

  All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.

• Overall Survival

  All subjects were followed for a minimum of 3 years after the first dose of OGX-011 or until death.

• Effect of OGX-011 on Serum Clusterin Levels

  Blood samples were collected at baseline and prior to infusion on Cycle 2 Day 1 and Cycle 3 Day 1

• Cmax of OGX-011

  Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.

• t1/2 of OGX-011

  Blood samples were collected as follows. Cycle 1; Day 1: pre-dose, 2 h (EOI), 0.5 h, 1 hr, 1.5 h, 2.5 h, 4 h, 6.5 h and 23.5 h post end of OGX-011 infusion, Day 22: pre-dose Cycle 2.

Interventions

custirsen sodium DRUG

Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused intravenously on Day 1 of this 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle = 21 days)

Also known as: OGX-011, TV-1011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically or cytologically confirmed diagnosis of NSCLC and must not have had chemotherapy or biological therapy for their disease.
• Stage IIIB (N3 and/or pleural or pericardial effusion) or IV disease that is not amenable to either surgery or radiation therapy of curative intent.
• Life expectancy of ≥ 12 weeks
• If patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
• Radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
• At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors \[RECIST\] (at least 10 mm in longest diameter by spiral computed tomography \[CT\] scan, or at least 20 mm by standard techniques).
• ECOG status must be ≤ 1

You may not qualify if:

• Prior chemotherapy or biological therapy (approved or experimental) for NSCLC, including adjuvant and neoadjuvant treatment.
• Presence of central nervous system (CNS) metastases, unless the patient has completed successful local therapy for CNS metastases, with the exception of leptomeningeal disease for which patients will be excluded. Patients must be off corticosteroids for at least 21 days prior to starting treatment.
• Second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
• Patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (This criteria is intended to exclude patients with stage IIIB disease, as defined by the presence of N3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)

Sponsors & Collaborators

• Achieve Life Sciences: lead

Study Sites (15)

LAC-USC Medical Center

Los Angeles, California, 90033, United States

Location

University of Southern California Norris

Los Angeles, California, 90033, United States

Location

New York Oncology Hematology

Albany, New York, 12208, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

BC Cancer Agency, Fraser Valley Centre

Surrey, British Columbia, Canada

Location

BC Cancer Agency, Vancouver Center

Vancouver, British Columbia, Canada

Location

Dr. H. Bliss Murphy Cancer Center

St. John's, Newfoundland and Labrador, Canada

Location

Royal Victoria Hospital of Barrie

Barrie, Ontario, Canada

Location

London Regional Cancer Centre

London, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

Toronto Sunnybrook Regional Cancer Center

Toronto, Ontario, Canada

Location

Hopital Laval

Ste-Foy, Quebec, Canada

Location

Related Publications (1)

• Laskin JJ, Nicholas G, Lee C, Gitlitz B, Vincent M, Cormier Y, Stephenson J, Ung Y, Sanborn R, Pressnail B, Nugent F, Nemunaitis J, Gleave ME, Murray N, Hao D. Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer. J Thorac Oncol. 2012 Mar;7(3):579-86. doi: 10.1097/JTO.0b013e31823f459c.

  PMID: 22198426 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

OGX-011

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Patricia Stewart, Vice President Medical Affairs
• Organization: OncoGenex Pharmaceuticals

psstewartmd@oncogenex.com

425-686-1500

Study Officials

• Janessa Laskin, M.D.

  BCCA, Vancouver Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: November 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 6, 2012
• Results First Posted: January 10, 2012

Record last verified: 2012-02

Locations

US (6); CA (9)