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

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Malignant pleural mesothelioma
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Brief Title

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

Official Title

Phase I Study of the Non-receptor Kinase Inhibitor 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Dose-limiting toxicity of the combination of bosutinib and pemetrexed

Secondary Outcome

 Adverse events of the combination of bosutinib and pemetrexed

Condition

Carcinoma, Non-Small-Cell Lung

Intervention

Bosutinib

Study Arms / Comparison Groups

 Bosutinib and Pemetrexed
Description:  Bosutinib and pemetrexed

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

36

Start Date

December 10, 2019

Completion Date

November 2021

Primary Completion Date

November 2020

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nagla Karim, MD, 706-721-1206, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03023319

Organization ID

EXP-16-01

Responsible Party

Sponsor-Investigator

Study Sponsor

Nagla Abdel Karim

Study Sponsor

Nagla Karim, MD, Principal Investigator, Augusta University Georgia Cancer Center

Verification Date

June 2020