Overview

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 January 2017
Trial size 11 participants
Trial identifier NCT02206763, GS-US-370-1298

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) 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

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Participants will receive MMB plus erlotinib.
mmb GS-0387
Tablet(s) administered orally once or twice daily
erlotinib Tarceva®
Tablet(s) administered orally once daily.

Primary Outcomes

Measure
Incidence of Dose Limiting Toxicities (DLTs)
time frame: Up to 28 days
Safety as Assessed by the Incidence of Adverse Events (AEs)
time frame: Up to 2 years plus 30 days
Safety as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Graded Lab Abnormalities (including Chemistry, Coagulation, Hematology, and Urinalysis)
time frame: Up to 2 years plus 30 days
Change from Baseline in Vital Signs
time frame: Up to 2 years

Secondary Outcomes

Measure
Progression-Free Survival
time frame: Until disease progression (up to 2 years)
Overall Survival
time frame: Until disease progression (up to 2 years)
Overall Response Rate
time frame: Until disease progression (up to 2 years)
Pharmacokinetic (PK) Parameter: Cmax of MMB
time frame: Predose and up to 24 hours postdose
PK Parameter: AUCtau of MMB
time frame: Predose and up to 24 hours postdose
PK Parameter: Cmax of Erlotinib
time frame: Predose and up to 24 hours postdose
PK Parameter: AUCtau of Erlotinib
time frame: Predose and up to 24 hours postdose

Eligibility Criteria

All participants at least 18 years old.

Key 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 Key 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 February 2017.
Information provided to ClinicalTrials.gov by Gilead Sciences.