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)
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 momelotinib (MMB) in combination with erlotinib. Escalation of momelotinib (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 momelotinib (MMB) treatment. There will be four dose levels and each treatment cycle will consist of 28 days.
Checked against the public recordLast updated Feb 1, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Sierra Oncology LLC - a GSK company
- Interventions being studied
- Drug: Momelotinib (MMB); Drug: Erlotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationDuarte, California
- Study locationPalo Alto, California
- Study locationWhittier, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 1, 2019. Always confirm current availability with the study team.