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.
|First Received Date||January 13, 2017|
|Last Changed Date||August 22, 2017|
|Start Date||January 2017|
|Anticipated Primary Completion Date||January 2020|
|Primary Outcome Measures||
Dose-limiting toxicity of the combination of bosutinib and pemetrexed [Time Frame: 21 days]
Maximum tolerated dose of the combination of bosutinib and pemetrexed [Time Frame: completion of dose escalation]
|Secondary Outcome Measures||
Adverse events of the combination of bosutinib and pemetrexed [Time Frame: 16 weeks]
Anti-tumor response rate [Time Frame: 6 and 12 weeks]
Progression-free survival [Time Frame: 6 and 12 weeks]
|Study Arms / Comparison Groups||1 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
UC Cancer Institute Clinical Trials Office
- 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 cancer.
- 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.
|Verification Date||August 2017|