This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||December 10, 2019||Phase 1||Interventional|
Primary Outcome 1 - Measure: Dose-limiting toxicity of the combination of bosutinib and pemetrexed
Primary Outcome 1 - Time Frame: 21 days
Primary Outcome 2 - Measure: Maximum tolerated dose of the combination of bosutinib and pemetrexed
Primary Outcome 2 - Time Frame: completion of dose escalation
- Pathologically or cytologically proven advanced, metastatic non-squamous non-small
cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian
cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical
- Measurable disease
- Life expectancy of greater than 3 months.
- Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.
- Untreated or symptomatic brain metastases.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Nagla Karim, MD
Role: Principal Investigator
Affiliation: Augusta University Georgia Cancer Center