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

NCT ID: NCT04173338

Last Updated: 2022-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-23

Study Completion Date

2022-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer Non-squamous Non-small-cell Lung Cancer Urothelial Carcinoma Malignant Mesothelioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cabozantinib + Pemetrexed

Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day.

Group Type EXPERIMENTAL

Cabozantinib

Intervention Type DRUG

start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.

Pemetrexed

Intervention Type DRUG

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

Interventions

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Cabozantinib

start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.

Intervention Type DRUG

Pemetrexed

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Nagla Abdel Karim

Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nagla A Karim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University Georgia Cancer Center

Locations

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Augusta University Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IST-65

Identifier Type: -

Identifier Source: org_study_id

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