Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors
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| ClinicalTrials.gov Identifier: NCT03023319 |
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Recruitment Status :
Recruiting
First Posted : January 18, 2017
Last Update Posted : June 16, 2020
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Sponsor:
Nagla Abdel Karim
Information provided by (Responsible Party):
Nagla Abdel Karim, Augusta University
- Study Details
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 36 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 |
| Estimated Primary Completion Date : | November 2020 |
| Estimated Study Completion Date : | November 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bosutinib and Pemetrexed
Bosutinib and pemetrexed
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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 :
- 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.
- Maximum tolerated dose of the combination of bosutinib and pemetrexed [ Time Frame: completion of dose escalation ]
Secondary Outcome Measures :
- Adverse events of the combination of bosutinib and pemetrexed [ Time Frame: 16 weeks ]
- Anti-tumor response rate [ Time Frame: 6 and 12 weeks ]
- 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
| Contact: Kelly Jenkins, RN, MSN | 706-721-1206 | kejenkins@augusta.edu | |
| Contact: Ashlyn Stevenson, RN, BSN | 706-721-0660 | asstevenson@augusta.edu |
Locations
| 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
| Principal Investigator: | Nagla Karim, MD | Augusta University Georgia Cancer Center |
| 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: | June 16, 2020 |
| Last Verified: | June 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 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 Folic Acid Antagonists |