Clinical Trials /

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

NCT03023319

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Cervical Carcinoma
  • Malignant Pleural Mesothelioma
  • Non-Squamous Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Thymic Carcinoma
  • Thymoma
  • Urethral Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT03023319

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: EXP-16-01
  • NCT ID: NCT03023319

Conditions

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

Interventions

DrugSynonymsArms
BosutinibBosutinib and Pemetrexed
PemetrexedBosutinib and Pemetrexed

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Bosutinib and PemetrexedExperimentalBosutinib and pemetrexed
  • Bosutinib
  • Pemetrexed

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicity of the combination of bosutinib and pemetrexed
Time Frame:21 days
Safety Issue:
Description:CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.

Secondary Outcome Measures

Measure:Adverse events of the combination of bosutinib and pemetrexed
Time Frame:16 weeks
Safety Issue:
Description:
Measure:Anti-tumor response rate
Time Frame:6 and 12 weeks
Safety Issue:
Description:
Measure:Progression-free survival
Time Frame:6 and 12 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nagla Abdel Karim

Last Updated

August 3, 2021