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Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma

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.
 
ClinicalTrials.gov Identifier: NCT04173338
Recruitment Status : Terminated (Closed by IRB on 3/28/22)
First Posted : November 21, 2019
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Nagla Abdel Karim, Augusta University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Non-squamous Non-small-cell Lung Cancer Urothelial Carcinoma Malignant Mesothelioma Drug: Cabozantinib Drug: Pemetrexed Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 23, 2020
Actual Primary Completion Date : March 28, 2022
Actual Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: Cabozantinib
start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.

Drug: Pemetrexed
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.


Outcome Measures
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Primary Outcome Measures :
  1. Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed [ Time Frame: 4 weeks or 28 days assessment. ]
    Dose-limiting toxicity of grade 3 or higher using CTCAE 5


Secondary Outcome Measures :
  1. Assess objective response rate (RR) [ Time Frame: To be measured through study completion; an average of 1 year. ]
    RR measured by Tumor response evaluation with RECIST

  2. Progression-free survival (PFS) [ Time Frame: To be measured through study completion; an average of 1 year. ]
    PFS measured from the time of study treatment to the date of progression.

  3. Overall survival (OS). [ Time Frame: OS measured through study completion, and an average of 1 year ]
    Measured from the time of start of treatment to time of death or time of last assessment.


Eligibility Criteria
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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
Criteria

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.
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): NCT04173338


Locations
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United States, Georgia
Augusta University Georgia Cancer Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Investigators
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Principal Investigator: Nagla A Karim, MD, PhD Augusta University Georgia Cancer Center
More Information
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Responsible Party: Nagla Abdel Karim, Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program, Augusta University
ClinicalTrials.gov Identifier: NCT04173338    
Other Study ID Numbers: IST-65
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Mesothelioma, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors