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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03023319
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Nagla Abdel Karim, Augusta University

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03023319


Contacts
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Contact: Kelly Jenkins, RN, MSN 706-721-1206 kejenkins@augusta.edu
Contact: Ashlyn Stevenson, RN, BSN 706-721-0660 asstevenson@augusta.edu

Locations
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United States, Georgia
Augusta University Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Kelly Jenkins, MSN, RN    706-721-1206    kejenkins@augusta.edu   
Contact: Ashlyn Stevenson, BSN, RN    706-721-0660    asstevenson@augusta.edu   
Principal Investigator: Nagla A Karim, MD, PhD         
Sponsors and Collaborators
Nagla Abdel Karim
Investigators
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Principal Investigator: Nagla Karim, MD Augusta University Georgia Cancer Center
More Information
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Responsible Party: Nagla Abdel Karim, Associate Professor of Medicine, Augusta University
ClinicalTrials.gov Identifier: NCT03023319    
Other Study ID Numbers: EXP-16-01
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
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
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Thymoma
Thymus Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms, Mesothelial
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Complex and Mixed
Lymphatic Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action