Back to resultsCabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
Primary Purpose
Non Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Urothelial Carcinoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cabozantinib
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility 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.
Sites / Locations
- Augusta University Georgia Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cabozantinib + Pemetrexed
Arm Description
Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
Outcomes
Primary Outcome Measures
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
Secondary Outcome Measures
Assess objective response rate (RR)
RR measured by Tumor response evaluation with RECIST
Progression-free survival (PFS)
PFS measured from the time of study treatment to the date of progression.
Overall survival (OS).
Measured from the time of start of treatment to time of death or time of last assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04173338
Brief Title
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Closed by IRB on 3/28/22
Study Start Date
January 23, 2020 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Urothelial Carcinoma, Malignant Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cabozantinib + Pemetrexed
Arm Type
Experimental
Arm Description
Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.
Intervention Type
Drug
Intervention Name(s)
Cabozantinib
Intervention Description
start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.
Primary Outcome Measure Information:
Title
Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Description
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
Time Frame
4 weeks or 28 days assessment.
Secondary Outcome Measure Information:
Title
Assess objective response rate (RR)
Description
RR measured by Tumor response evaluation with RECIST
Time Frame
To be measured through study completion; an average of 1 year.
Title
Progression-free survival (PFS)
Description
PFS measured from the time of study treatment to the date of progression.
Time Frame
To be measured through study completion; an average of 1 year.
Title
Overall survival (OS).
Description
Measured from the time of start of treatment to time of death or time of last assessment.
Time Frame
OS measured through study completion, and an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagla A Karim, MD, PhD
Organizational Affiliation
Augusta University Georgia Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augusta University Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
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