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

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ClinicalTrials.gov Identifier: NCT03023319
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Nagla Karim, University of Cincinnati

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)
Estimated Enrollment : 24 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
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020


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 ]


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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.


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: UC Cancer Institute Clinical Trials Office 513-584-7698 kastla@ucmail.uc.edu

Locations
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United States, Ohio
UC Health Recruiting
Cincinnati, Ohio, United States, 45219
Contact: UCCI Clinical Trials Office    513-584-7698    kastla@ucmail.uc.edu   
Sponsors and Collaborators
Nagla Karim
Investigators
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Principal Investigator: Nagla Karim, MD University of Cincinnati

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Responsible Party: Nagla Karim, Associate Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03023319     History of Changes
Other Study ID Numbers: UCCI-EXP-16-01
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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