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

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Georgia Cancer Center

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.
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.

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.
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
4 weeks or 28 days assessment.

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.
RR measured by Tumor response evaluation with RECIST
To be measured through study completion; an average of 1 year.
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.
To be measured through study completion; an average of 1 year.
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.
OS measured through study completion, and an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

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

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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