Trial Outcomes & Findings for Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer (NCT NCT00750555)

NCT ID: NCT00750555

Last Updated: 2019-02-26

Results Overview

Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

1 year

Results posted on

2019-02-26

Participant Flow

After the enrollment of 4 participants in this study, the PI left Geisinger. Geisinger does not have any details regarding which Arm/Group participants were assigned to.

Participant milestones

Participant milestones
Measure
One Year Disease Free
Erlotinib: 150 mg per day orally until disease progression occurs, up to a maximum of 12 months
Overall Study
STARTED
0
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maintenance of Tarceva (Erlotinib) in Patients With Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.

Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data table.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.

Per our current document retention policy, and the fact that the investigator, study staff, and record owner are no longer employed at our site, we do not have any collected data for pre-specified Primary and Secondary Outcome Measures to report in Outcome Measure data tables.

Outcome measures

Outcome data not reported

Adverse Events

One Year Disease Free

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

Office of Research Compliance

Geisinger

Phone: 570-214-9628

Results disclosure agreements

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