Trial Outcomes & Findings for Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205 (NCT NCT01247922)
NCT ID: NCT01247922
Last Updated: 2024-12-06
Results Overview
Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.
TERMINATED
PHASE2
4 participants
From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)
2024-12-06
Participant Flow
Participants recruited for this OSI-774-206 study were participants with pediatric ependymoma previously treated with oral etoposide in Study OSI-774-205 who progressed while on study or discontinued due to unacceptable toxicity.
Participants who consented to enter this OSI-774-206 study and fulfilled all the eligibility criteria (no more than 14 days prior to registration) were enrolled in this study no more than 21 days from the last dose of oral etoposide in Study OSI-774-205.
Participant milestones
| Measure |
Erlotinib
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
Treated
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Erlotinib
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Overall Study
Disease progression
|
4
|
Baseline Characteristics
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Baseline characteristics by cohort
| Measure |
Erlotinib
n=4 Participants
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Indian subcontinent
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)Population: The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug.
Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.
Outcome measures
| Measure |
Erlotinib
n=4 Participants
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
Any TEAE
|
4 participants
|
|
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
With at least 1 SAE
|
2 participants
|
|
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
With at least 1 treatment-related SAE
|
0 participants
|
|
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
Discontinued study due to treatment-related AEs
|
0 participants
|
|
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
Died on treatment or within 30 days
|
1 participants
|
SECONDARY outcome
Timeframe: End of treatment (The mean treatment duration was 170.5 days.)Population: SAF
Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.
Outcome measures
| Measure |
Erlotinib
n=4 Participants
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Best Overall Response
Complete response
|
0 participants
|
|
Best Overall Response
Partial response
|
0 participants
|
|
Best Overall Response
Minor response
|
0 participants
|
|
Best Overall Response
Stable disease
|
2 participants
|
|
Best Overall Response
Disease progression
|
2 participants
|
SECONDARY outcome
Timeframe: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)Population: SAF
Outcome measures
| Measure |
Erlotinib
n=4 Participants
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Median Treatment Duration
|
91.0 days
Interval 27.0 to 473.0
|
Adverse Events
Erlotinib
Serious adverse events
| Measure |
Erlotinib
n=4 participants at risk
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Nervous system disorders
Convulsion
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Nervous system disorders
VIIth nerve paralysis
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
General disorders
Brain death
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
Other adverse events
| Measure |
Erlotinib
n=4 participants at risk
Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
|
|---|---|
|
Vascular disorders
Peripheral coldness
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Investigations
Weight decreased
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Investigations
Weight increased
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
50.0%
2/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Nervous system disorders
Dysarthria
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Nervous system disorders
Partial seizures
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
General disorders
Fatigue
|
75.0%
3/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
General disorders
Pain
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
General disorders
Pyrexia
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
|
Infections and infestations
Rash pustular
|
25.0%
1/4 • From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for an additional to 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER