A Randomized, Phase 2, Study to Assess the Safety and Activity of CRLX101, a Nanoparticle Formulation of Camptothecin, in Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed One or Two Previous Regimens of Chemotherapy

NewLink Genetics Corporation25 sites in 2 countries157 target enrollmentJune 2011

ConditionsNon-Small Cell Lung Cancer

InterventionsCRLX101 Best Supportive Care

DrugsCRLX101

Overview

Phase: Phase 2
Intervention: CRLX101
Conditions: Non-Small Cell Lung Cancer
Sponsor: NewLink Genetics Corporation
Enrollment: 157
Locations: 25
Primary Endpoint: To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare median overall survival of patients with advanced non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best supportive care (BSC).

Detailed Description

Lung cancer remains the leading cause of cancer-related mortality in men and women worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer. The development of targeted therapies has changed the approach to treating NSCLC significantly over the past decade with targeted therapies generally possessing safety advantages over traditional cytotoxic regimens. However, combination paradigms and resistance patterns complicate the use of these agents. CRLX101 is a nanoparticle comprised of camptothecin (CPT) conjugated to a cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

October 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NewLink Genetics Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients who are ≥ 18-years of age.
•Histologically or cytologically confirmed, locally advanced or metastatic NSCLC (adenocarcinoma, bronchoalveolar, squamous cell, large cell, or mixed carcinoma) that is not amendable to surgical treatment and patient has have failed 1 or 2 different lines of chemotherapy.
•Measureable disease and evidence of progression on the previous therapy. Progression may be clinical or radiological.
•ECOG performance status of 0 or
•Life expectancy of at least 3 months.
•Hemoglobin ≥ 10 g/dL.
•Absolute neutrophil count (ANC) ≥ 1500 cells/µL without growth factor support.
•Platelet count ≥ 100,000 cells/µL without support.
•Adequate hepatic and renal function including the following: Total bilirubin \< 2 × ULN, AST or ALT ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastasis, PTT within normal limits, INR ≤ 1.5, Serum Creatinine \<1.5 ULN
•At least 4 weeks post any radiotherapy or biological therapy; at least 6 weeks post nitrosoureas therapy.

Exclusion Criteria

•CNS metastases by radiologic evidence or histology, unless clinically stable (must have been treated by resection or radiation) for at least 4 weeks prior to first dose of study drug. Patients may not be receiving dexamethasone for control of CSF pressure.
•Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low dose aspirin and low-weight heparin only are allowed.
•More than 2 previous lines of chemotherapy for lung cancer. This includes biologic (immunotherapy) therapy.
•History of previous cerebrovascular accident (CVA) or history transient ischemic attack (TIA) within 6 months of study entry.
•History of prior malignancy not cured by excision. Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least 2-year disease free interval.
•Recent history (within 6 months of screening) of unstable angina, myocardial infarction, or NYHA Class III or IV congestive heart failure
•History of cardiac arrhythmia requiring medical or electrical therapy.
•QTc \> 450 msec for males and \> 470 msec for females.
•Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.
•History of organ or bone marrow transplant.