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BRIEF TITLE: Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors

Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors


  • Org Study ID: UCCI-EXP-16-01
  • Secondary ID:
  • NCT ID: NCT03023319
  • NCT Alias:
  • Sponsor: Nagla Karim - Other
  • Source: University of Cincinnati

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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: January 2017 Phase 1 Interventional

Primary Outcomes:

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

Condition:

  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
  • Bladder Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • Thymoma
  • Thymus Cancer
  • Uterine Cervical Cancer

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Nagla Karim, MD

Role: Principal Investigator

Affiliation: University of Cincinnati

Overall Contact

Name: UC Cancer Institute Clinical Trials Office

Phone: 513-584-7698

Email: kastla@ucmail.uc.edu

Location

Facility Status Contact
UC Health
Cincinnati, Ohio 45219
United States
Recruiting UCCI Clinical Trials Office
513-584-7698
kastla@ucmail.uc.edu