- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173338
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
June 10, 2022 updated by: Nagla Abdel Karim, Augusta University
Phase I Study of Cabozantinib in Combination With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC), Urothelial Cancer and Advanced Malignant Mesothelioma
This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma.
This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Augusta, Georgia, United States, 30912
- Augusta University Georgia Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
- 18 years or older.
- At least one prior chemotherapy before entering in this trial.
- Not pregnant or breastfeeding.
Exclusion Criteria:
- Prior treatment with cabozantinib.
- Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
- History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cabozantinib + Pemetrexed
Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
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start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Time Frame: 4 weeks or 28 days assessment.
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Dose-limiting toxicity of grade 3 or higher using CTCAE 5
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4 weeks or 28 days assessment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess objective response rate (RR)
Time Frame: To be measured through study completion; an average of 1 year.
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RR measured by Tumor response evaluation with RECIST
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To be measured through study completion; an average of 1 year.
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Progression-free survival (PFS)
Time Frame: To be measured through study completion; an average of 1 year.
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PFS measured from the time of study treatment to the date of progression.
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To be measured through study completion; an average of 1 year.
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Overall survival (OS).
Time Frame: OS measured through study completion, and an average of 1 year
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Measured from the time of start of treatment to time of death or time of last assessment.
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OS measured through study completion, and an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nagla A Karim, MD, PhD, Augusta University Georgia Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2020
Primary Completion (Actual)
March 28, 2022
Study Completion (Actual)
March 28, 2022
Study Registration Dates
First Submitted
November 14, 2019
First Submitted That Met QC Criteria
November 20, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
June 14, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- IST-65
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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