Status:
TERMINATED
Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
Lead Sponsor:
Clovis Oncology, Inc.
Conditions:
Locally Advanced or Metastatic Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type...
Detailed Description
Lung cancer remains the most common cancer worldwide with non-small cell lung cancer accounting for 85% of cases. Cytotoxic chemotherapy has been the mainstay of patients with NSCLC; however, survival...
Eligibility Criteria
Inclusion
- Inclusion Criteria -
- All patients must meet the following inclusion criteria:
- Metastatic or unresectable locally advanced NSCLC
- Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion
- Biopsy of either primary or metastatic tumor tissue within 60 days of dosing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Minimum age of 18 years
- Adequate hematological and biological function
- Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation
- Phase 2 Cohorts must also meet the following inclusion criteria:
- Disease progression confirmed by radiologic assessment while on treatment with EGFR- TKI Or
- Disease progression confirmed by radiologic assessment while on treatment with the first single agent EGFR TKI and
- Documented evidence of T790M mutation in EGFR following disease progression on the first single agent EGFR TKI.
- Measureable disease according to RECIST Version 1.1
- Exclusion Criteria -
- Any of the following criteria will exclude patients from study participation:
- Documented evidence of an Exon 20 insertion activating mutation in the EGFR gene
- Active second malignancy
- Known pre-existing interstitial lung disease
- Patients with Leptomeningeal carcinomatosis are excluded. Other CNS metastases are only permitted if treated, asymptomatic and stable (not requiring steroids for at least 4 weeks prior to start of study treatment).
- Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
- Prior treatment with rociletinib or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR
- Certain cardiac abnormalities or history
- Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib
- Females who are pregnant or breastfeeding
- Refusal to use adequate contraception for fertile patients (females and males) for 12 weeks after the last dose of rociletinib
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
- Any other reason the investigator considers the patient should not participate in the study
Exclusion
Key Trial Info
Start Date :
March 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2018
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT01526928
Start Date
March 27 2012
End Date
August 27 2018
Last Update
August 4 2020
Active Locations (49)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States, 92708
3
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Samuel Oschin Cancer Center
Los Angeles, California, United States, 90048