Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (1)

Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed
Dose-limiting toxicity of grade 3 or higher using CTCAE 5
4 weeks or 28 days assessment.

Secondary Outcomes (3)

Assess objective response rate (RR)
To be measured through study completion; an average of 1 year.
Progression-free survival (PFS)
To be measured through study completion; an average of 1 year.
Overall survival (OS).
OS measured through study completion, and an average of 1 year

Study Arms (1)

Cabozantinib + Pemetrexed

EXPERIMENTAL

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

Drug: CabozantinibDrug: Pemetrexed

Interventions

CabozantinibDrug

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

Cabozantinib + Pemetrexed

PemetrexedDrug

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

Cabozantinib + Pemetrexed

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
years or older.

Sponsors & Collaborators

Augusta University
Otherlead

Study Sites (1)

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Transitional CellMesothelioma, Malignant

Interventions

cabozantinibPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Nagla A Karim, MD, PhD
Augusta University Georgia Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

9 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 21, 2019

Study Start

January 23, 2020

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Cabozantinib + Pemetrexed

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Cabozantinib + Pemetrexed

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations