Trial Outcomes & Findings for Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma (NCT NCT00387894)

NCT ID: NCT00387894

Last Updated: 2013-06-04

Results Overview

Lack of disease progression indicates response to treatment

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Every 8 weeks or as indicated
• Results posted on: 2013-06-04

Participant Flow

Participant milestones

Measure	Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28 Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28 Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma

Baseline characteristics by cohort

Measure	Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28 n=6 Participants erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	44 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 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	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 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	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks or as indicated

Population: 5 participants evaluable while receiving study treatment

Lack of disease progression indicates response to treatment

Outcome measures

Measure	Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28 n=5 Participants erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Disease Response Measured Objectively by MRI of Brain Disease progression prior to 8 weeks	4 participants
Disease Response Measured Objectively by MRI of Brain Disease responsive at 8 Weeks	1 participants
Disease Response Measured Objectively by MRI of Brain Disease responsive at 16 Weeks	0 participants

SECONDARY outcome

Timeframe: Until first observation of progressive disease, non-reversible neurologic progression or permanently increased steroid requirement (stable disease only), death due to any cause (up to 16 weeks)

Patients with stable or responding disease will continue treatment until tumor progression is determined

Outcome measures

Measure	Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28 n=5 Participants erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Duration of Progress-free Survival (PFS) 2 weeks PFS	1 participants
Duration of Progress-free Survival (PFS) 3 weeks PFS	1 participants
Duration of Progress-free Survival (PFS) 6 weeks PFS	2 participants
Duration of Progress-free Survival (PFS) 12 weeks PFS	1 participants

Adverse Events

Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28 n=6 participants at risk erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Disease progression	100.0% 6/6 • Number of events 6 • 30 days after the last study treatment, thereafter for survival Only AEs Grade 3 or higher were required to be collected as AEs, per protocol
Nervous system disorders Neuropathy	16.7% 1/6 • Number of events 1 • 30 days after the last study treatment, thereafter for survival Only AEs Grade 3 or higher were required to be collected as AEs, per protocol
Skin and subcutaneous tissue disorders Wound complication	16.7% 1/6 • Number of events 1 • 30 days after the last study treatment, thereafter for survival Only AEs Grade 3 or higher were required to be collected as AEs, per protocol
General disorders Seizure	16.7% 1/6 • Number of events 1 • 30 days after the last study treatment, thereafter for survival Only AEs Grade 3 or higher were required to be collected as AEs, per protocol
General disorders Confusion	16.7% 1/6 • Number of events 1 • 30 days after the last study treatment, thereafter for survival Only AEs Grade 3 or higher were required to be collected as AEs, per protocol

Other adverse events

Adverse event data not reported

Additional Information

Michael Prados, MD

University of California San Francisco

Phone: 415-353-7500

Email: PradosM@neurosurg.ucsf.edu

Results disclosure agreements

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