This trial is active, not recruiting.

Condition egfr mutated egfr tki naive metastatic nsclc
Treatments mmb, erlotinib
Phase phase 1
Targets EGFR, JAK, JAK1, JAK2
Sponsor Gilead Sciences
Start date October 2014
End date December 2016
Trial size 11 participants
Trial identifier NCT02206763, GS-US-370-1298


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) combined with erlotinib in adults with epidermal growth factor receptor (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung cancer (NSCLC). Participants will be sequentially enrolled to receive progressively increasing doses of MMB in combination with erlotinib. Escalation of MMB doses will proceed to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT) during the first 28 days of combined erlotinib and MMB treatment. There will be four dose levels and each treatment cycle will consist of 28 days.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Participants will receive MMB plus erlotinib.
mmb GS-0387
Momelotinib (MMB) tablet(s) administered orally once or twice daily
erlotinib Tarceva®
Erlotinib tablet(s) administered orally once daily.

Primary Outcomes

Incidence of dose limiting toxicities (DLTs)
time frame: Up to 28 days

Secondary Outcomes

Progression-free survival
time frame: Until disease progression (up to 2 years)
Overall survival
time frame: Until disease progression (up to 2 years)
Until disease progression (up to 2 years)
time frame: Up to 2 years
PK profile of MMB
time frame: Predose and postdose on Days 1 and 15
PK profile of erlotinib
time frame: Predose and postdose on Days 1 and 15

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title A Phase 1b Study of Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naïve Metastatic Non-Small Cell Lung Cancer (NSCLC)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.
Location data was received from the National Cancer Institute and was last updated in October 2016.