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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03023319
Recruitment Status : Completed
First Posted : January 18, 2017
Last Update Posted : June 14, 2022
Information provided by (Responsible Party):
Nagla Abdel Karim, Augusta University

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Mesothelioma Bladder Cancer Ovarian Cancer Peritoneal Cancer Thymoma Thymus Cancer Uterine Cervical Cancer Drug: Bosutinib Drug: Pemetrexed Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
Actual Study Start Date : December 10, 2019
Actual Primary Completion Date : May 10, 2022
Actual Study Completion Date : May 10, 2022

Arm Intervention/treatment
Experimental: Bosutinib and Pemetrexed
Bosutinib and pemetrexed
Drug: Bosutinib
100mg daily for 4 cycles (21 days per cycle)

Drug: Pemetrexed
500 mg/m2 every 21 days for 4 cycles

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03023319

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United States, Georgia
Augusta University Georgia Cancer Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Nagla Abdel Karim
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Principal Investigator: Nagla Karim, MD Augusta University Georgia Cancer Center
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Responsible Party: Nagla Abdel Karim, Associate Professor of Medicine, Augusta University Identifier: NCT03023319    
Other Study ID Numbers: EXP-16-01
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Carcinoma, Non-Small-Cell Lung
Thymus Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Complex and Mixed
Lymphatic Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists