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

Sponsor
Augusta University (Other)
Overall Status
Terminated
CT.gov ID
NCT04173338
Collaborator
(none)
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Study Details

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.

Study Design

Study Type:
Interventional
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 :
Jan 23, 2020
Actual Primary Completion Date :
Mar 28, 2022
Actual Study Completion Date :
Mar 28, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed [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) [To be measured through study completion; an average of 1 year.]

    RR measured by Tumor response evaluation with RECIST

  2. Progression-free survival (PFS) [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). [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Augusta University Georgia Cancer Center Augusta Georgia United States 30912

Sponsors and Collaborators

  • Augusta University

Investigators

  • Principal Investigator: Nagla A Karim, MD, PhD, Augusta University Georgia Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Nov 21, 2019
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022