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)
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/3/2019 |
| Start Date: | October 16, 2014 |
| End Date: | February 16, 2017 |
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)
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.
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.
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.
We found this trial at
3
sites
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