Overview

This trial is active, not recruiting.

Condition stage iv small cell lung cancer
Treatments omp-59r5, etoposide, placebo, cisplatin or carboplatin
Phase phase 1/phase 2
Sponsor OncoMed Pharmaceuticals, Inc.
Start date May 2013
End date August 2017
Trial size 145 participants
Trial identifier NCT01859741, 59R5-003

Summary

The study consists of a Phase1b lead-in portion to determine the MTD of OMP-59R5 in combination with EP for 6 cycles followed a Phase 2, multicenter, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in subjects receiving first-line therapy for extensive stage small cell lung cancer.

United States Connecticut, District of Columbia, Illinois, Maryland, Michigan, New York, Ohio, and Texas
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
omp-59r5
OMP-59R5 administered intravenously
etoposide
administered intravenously
placebo
administered IV
cisplatin or carboplatin
administered intravenously
(Experimental)
omp-59r5
OMP-59R5 administered intravenously
etoposide
administered intravenously
placebo
administered IV
cisplatin or carboplatin
administered intravenously

Primary Outcomes

Measure
Dose limiting toxicities (DLT) of OMP-59R5 in combination with Etoposide and Cisplatin
time frame: Subjects will be treated and observed for DLT through the end of the first cycle (28 days)
Progression-free survival
time frame: Number of days from randomization until death or disease progression, assessed up 25 months

Secondary Outcomes

Measure
PK of OMP-59R5 when given in combination with Etoposide and Cisplatin.
time frame: Days 1, 3 and 8 of Cycle 1 and 3, and treatment termination
Overall survival, 12 month OS and overall response rate
time frame: Throughout the study, and approximately every 6 weeks after the treatment termination
Number of participants with adverse events as a measure of safety and tolerability
time frame: Every 3 weeks till the patient comes off the study treatment, up to 25 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Histologically or cytologically documented extensive stage small cell lung cancer. 2. Adults of 18 years of age or older. 3. Performance Status (ECOG) of 0 or 1. 4. FFPE tumor tissue. 5. Adequate organ function: 1. Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL). 2. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault formula). 3. Adequate hepatic function (alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], ALT may be ≤ 5 x ULN if due to liver metastases but cannot be associated with concurrent elevated bilirubin >1.5xULN unless it is approved by the Sponsor's Medical Monitor). 4. Prothrombin Time (PT)/International Normalized Ration (INR) ≤1.5 × ULN, activated partial thromboplastin time (aPTT) ≤1.5 × ULN. 6. Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation. 7. For women of child-bearing potential, negative serum pregnancy test at screening and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last. 8. Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration or the last EP in the study, whichever is discontinued last. Exclusion Criteria: Subjects who meet any of the following criteria will not be eligible for participation in the study: 1. Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation. 2. Prior therapy including radiation, chemotherapy or surgery for newly diagnosed extensive stage small cell lung cancer. 3. Presence of any serious or uncontrolled illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure unstable angina pectoris, uncontrolled cardiac arrhythmia, uncontrolled arterial thrombosis, symptomatic pulmonary embolism, and psychiatric illness that would limit compliance with study requirement. 4. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within 6 months prior to the first administration of study drug. 5. A history of malignancy with the exception of: 1. Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer 2. Adequately treated stage I cancer from which the subject is currently in remission, or 3. Any other cancer from which the subject has been disease-free for ≥ 3 years 6. Known human immunodeficiency virus (HIV) infection. 7. Females who are pregnant or breastfeeding. 8. Concurrent use of therapeutic warfarin (prophylactic low dose of warfarin, i.e., 1 mg daily for port catheter is allowed)

Additional Information

Official title A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by OncoMed Pharmaceuticals, Inc..