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NCT Number: NCT03023319

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Adenoma Adnexal Diseases Bladder Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hemic and Lymphatic Diseases Lung Diseases Lung Neoplasms Lymphatic Diseases Male Urogenital Diseases Mesothelioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Peritoneal Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Thymoma Thymus Cancer Thymus Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosutinib

Drug

100mg daily for 4 cycles (21 days per cycle)

Pemetrexed

Drug

500 mg/m2 every 21 days for 4 cycles

Primary outcomes

  1. Dose-limiting toxicity of the combination of bosutinib and pemetrexed

    Time frame: 21 days

    CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.

  2. Maximum tolerated dose of the combination of bosutinib and pemetrexed

    Time frame: completion of dose escalation

Secondary outcomes

  1. Adverse events of the combination of bosutinib and pemetrexed

    Time frame: 16 weeks

  2. Anti-tumor response rate

    Time frame: 6 and 12 weeks

  3. Progression-free survival

    Time frame: 6 and 12 weeks

Sponsors and collaborators

Lead sponsor

Nagla Abdel Karim

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2017
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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