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Trial Outcomes & Findings for Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme (NCT NCT00445588)

NCT ID: NCT00445588

Last Updated: 2016-04-27

Results Overview

death. measured by time of first day of treatment until date of death, assessed up to 2 years.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Time of first day of the treatment to death, assessed up to 2 years

Results posted on

2016-04-27

Participant Flow

Adult pts accured in an outpatient clinic between Jan 2007 and October 2007. pts had to have measurable , histologically proven GBM, that had progressed following radiation therapy and 0-2 prior chemotherapies.

Participant milestones

Participant milestones
Measure
Treatment
Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study erlotinib hydrochloride 150mg: Given orally once daily sorafenib tosylate 400mg: Given orally twice daily pharmacological study: Correlative studies
Overall Study
STARTED
56
Overall Study
COMPLETED
56
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment
n=56 Participants
Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study erlotinib hydrochloride: 150mg Given orally once daily sorafenib tosylate: 400mg Given orally twice daily pharmacological study: Correlative studies
Age, Continuous
56 years
n=5 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
Sex: Female, Male
Male
35 Participants
n=5 Participants
Karnosky Performance Status
90-100
26 participants
n=5 Participants
Karnosky Performance Status
60-80
30 participants
n=5 Participants

PRIMARY outcome

Timeframe: Time of first day of the treatment to death, assessed up to 2 years

death. measured by time of first day of treatment until date of death, assessed up to 2 years.

Outcome measures

Outcome measures
Measure
Treatment
n=56 Participants
Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study erlotinib hydrochloride 150mg: Given orally once daily sorafenib tosylate 400mg: Given orally twice daily pharmacological study: Correlative studies
Overall Survival
5.7 months
Interval 4.5 to 7.9

SECONDARY outcome

Timeframe: At 6 months- defined as patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up

defined patient started treatment is alive and progression free at the time of 26-week (6 months) follow-up

Outcome measures

Outcome measures
Measure
Treatment
n=56 Participants
Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study erlotinib hydrochloride 150mg: Given orally once daily sorafenib tosylate 400mg: Given orally twice daily pharmacological study: Correlative studies
6months -Progression-free Survival Rate
14 percentage of participants
Interval 8.0 to 28.0

Adverse Events

Treatment

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Treatment
n=56 participants at risk
Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study erlotinib hydrochloride: 150mg Given orally once daily sorafenib tosylate: 400mg Given orally twice daily pharmacological study: Correlative studies
General disorders
fatigue
8.9%
5/56 • Number of events 5 • events collected from first day of dosing till off treatment - approximately 2 years
Investigations
lipase increased
7.1%
4/56 • Number of events 4 • events collected from first day of dosing till off treatment - approximately 2 years

Additional Information

David Peereboom, MD

Adult Brain Tumor Consortium

Phone: 216-445-6068

Results disclosure agreements

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

Restriction type: LTE60