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Brief Title: 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

INTRODUCTION

  • Org Study ID: EXP-16-01
  • Secondary ID: N/A
  • NTC ID: NCT03023319
  • Sponsor: Nagla Abdel Karim

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.

  • Overall Status
    Recruiting
  • Start Date
    December 10, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose-limiting toxicity of the combination of bosutinib and pemetrexed

Primary Outcome 1 - Timeframe: 21 days

Primary Outcome 2 - Measure: Maximum tolerated dose of the combination of bosutinib and pemetrexed

Primary Outcome 2 - Timeframe: completion of dose escalation

CONDITION

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

ELIGIBILITY

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nagla Karim, MD

Role: Principal Investigator

Affiliation: Augusta University Georgia Cancer Center

Overall Contact

Name: Nagla Karim, MD

Phone: 706-721-1206, 706-721-0660

Email: kejenkins@augusta.edu, asstevenson@augusta.edu

LOCATION

Facility Status Contact
Facility: Augusta University Georgia Cancer Center
Augusta, Georgia 30912
United States
Status: Recruiting Contact: Contact
Kelly Jenkins, MSN, RN
706-721-1206
kejenkins@augusta.edu