Status:
TERMINATED
Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sierra Oncology LLC - a GSK company
Conditions:
EGFR Mutated EGFR TKI Naive Metastatic NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of momelotinib (MMB) combine...
Eligibility Criteria
Inclusion
- Key
- Metastatic NSCLC with documented EGFR exon 19 deletion or exon 21 (L858R) substitution mutation
- Treatment naive OR one prior standard chemotherapy that is platinum-based
- Adequate organ function defined as follows:
- Hepatic: Total bilirubin \< upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
- Hematological: absolute neutrophil count (ANC) ≥1500 cells/mm\^3, platelet ≥ 100,000 cells/mm\^3, hemoglobin ≥ 9.0 g/dL
- Renal: Serum creatinine \< ULN OR calculated creatinine clearance (CLcr) of ≥ 60 ml/min
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Key
Exclusion
- Known positive status for human immunodeficiency virus (HIV)
- Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C)
- Presence of \> Grade 1 peripheral neuropathy
- Symptomatic leptomeningeal, brain metastases, or spinal cord compression.
- History of interstitial pneumonitis
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
October 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02206763
Start Date
October 16 2014
End Date
February 16 2017
Last Update
February 1 2019
Active Locations (3)
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1
Duarte, California, United States
2
Palo Alto, California, United States
3
Whittier, California, United States