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Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Brief Summary

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.

Tracking Information
First Received DateJanuary 13, 2017
Last Changed DateJanuary 13, 2017
Start DateJanuary 2017
Anticipated Primary Completion DateJanuary 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]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
  • Bladder Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Thymoma
  • Thymus Cancer
  • Uterine Cervical Cancer
Intervention
  • Drug: Bosutinib
  • Drug: Pemetrexed
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment24
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact UC Cancer Institute Clinical Trials Office
Email: kastla@ucmail.uc.edu
Phone: 513-584-7698
Eligibility Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Untreated or symptomatic brain metastases.

Administrative Information
NCTIDNCT03023319
Responsible Party,
SponsorNagla Karim
Verification DateJanuary 2017
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