MedDataX Logo

Trial Outcomes & Findings for Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer (NCT NCT02693717)

NCT ID: NCT02693717

Last Updated: 2021-05-20

Results Overview

Will be defined as the number of subjects with complete response or partial response by Response Assessment in Solid Tumors 1.1 criteria divided by the total number of subjects receiving their first dose of trial therapy. Objective response rates will be summarized using descriptive statistics.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2021-05-20

Participant Flow

The participants were accrued starting in Sept 2017 through January 2019.

Participant milestones

Participant milestones
Measure
Pemetrexed
Intravenous infusion 500 mg/m2 every 21 days
Overall Study
STARTED
7
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pemetrexed
n=7 Participants
Intravenous infusion 500 mg/m2 every 21 days
Age, Continuous
73.6 years
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
Race (NIH/OMB)
White
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
7 participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Study terminated early, no data collected

Will be defined as the number of subjects with complete response or partial response by Response Assessment in Solid Tumors 1.1 criteria divided by the total number of subjects receiving their first dose of trial therapy. Objective response rates will be summarized using descriptive statistics.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from trial entry to the first documented tumor progression as determined by the investigator using the Response Evaluation Criteria in Solid Tumors 1.1 criteria or death from any cause, assessed at 2 years

Population: Study terminated early, no data collected

Progression-free survival will be estimated and plotted with the methods of Kaplan and Meier.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from trial entry to death from any cause, assessed at 2 years

Population: Study terminated early, no data collected

Overall survival will be estimated and plotted with the methods of Kaplan and Meier.

Outcome measures

Outcome data not reported

Adverse Events

Pemetrexed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jianjun Gao, MD PHD, Associate Professor, Genitourinary Medical Oncology

UT MD Anderson Cancer Center

Phone: (713) 563-4195

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place