EpendymomaPhase 2NCT01247922
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
A Phase 2 study testing Erlotinib in people with Ependymoma, run by OSI Pharmaceuticals at 21 sites in 3 countries.
Trial summary
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with… Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Ependymoma
- What is being tested?
- Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 23 May 2011to 13 Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide
- Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or Karnofsky ≥ 50% for patients greater than 10 years of age
- Patients must have recovered from any acute toxicity to any prior anti-cancer treatment
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic transaminase (SGPT) ALT ≤ 3 x ULN
- Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m2
- Patients must be neurologically stable for at least 7 days before registration
- Patients, both males and females, with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy
- Patients must be able to take erlotinib orally
Who cannot join
- Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before registration
- Have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from OSI-774-205
- Taking proton pump inhibitors ≤ 14 days before registration
- Participating in another investigational drug trial while on study
- Pregnant or breast-feeding
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States11 sites
Emory University Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
The Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Wisconsin
Madison, Wisconsin, 53705-2275
University of Miami
Miami, Florida, 33136
University of Minnesota - Amplatz Children's Hospital
Minneapolis, Minnesota, 55455
Children's Hospital of Orange County (CHOC)
Orange, California, 92868
Packard Children's Hospital
Palo Alto, California, 94304
Childrens Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Oregon Health & Sciences University Doernbecher Children's Hospital
Portland, Oregon, 97124
Children's National Medical Center -D.C. Center for Cancer and Blood Disorders
Washington D.C., District of Columbia, 20010
United Kingdom7 sites
Birmingham Children's Hospital Oncology Department
Birmingham, B4 6NH
Royal Hospital for Sick Children
Glasgow, G3 8SJ
Paediatric Oncology and Haematology Offices,
Leeds, LS1 3EX
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 1AP
Royal Manchester Children's Hospital Ward 84
Manchester, M13 9W2
University of Nottingham
Nottingham, NG7 2UH
Royal Marsden Hospital
Sutton, SM2 5pt
Canada3 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Children's and Women's Health Center of BC
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.
Read the detailed description
The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.
- Conditions
- Ependymoma
- Being tested
- Erlotinib
- Keywords
- Pediatric Ependymoma, Ependymoma, Tarceva, Erlotinib
- Medical subject headings
- Ependymoma, Familial ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva, OSI-774
continuous oral Erlotinib 85 mg/m^2 per day
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
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.
Measured: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)
Secondary outcomes (2)
Best Overall Response
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.
Measured: End of treatment (The mean treatment duration was 170.5 days.)
Median Treatment Duration
Measured: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study start23 May 2011
- Primary completion13 Sep 2012
- Study completion13 Sep 2012
Why it stopped: In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpendymomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Astellas Pharma Global Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247922
- Sponsor's protocol ID
- OSI-774-206
- Other IDs
- 2010-023478-38
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2010
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205
- ClinicalTrials.gov ID
- NCT01247922
- Acronym / sponsor ID
- OSI-774-206
- Conditions
- Ependymoma
- Keywords
- Pediatric Ependymoma, Ependymoma, Tarceva, Erlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped
- Enrolment
- 4 participants (actual)
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 May 2011 (actual)
- Primary completion
- 13 Sep 2012 (actual)
- Study completion
- 13 Sep 2012 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Posted 11 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.
Detailed description
The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: ErlotinibParticipants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide
- Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or Karnofsky ≥ 50% for patients greater than 10 years of age
- Patients must have recovered from any acute toxicity to any prior anti-cancer treatment
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic transaminase (SGPT) ALT ≤ 3 x ULN
- Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m2
Key exclusion criteria (5 listed)
- Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before registration
- Have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from OSI-774-205
- Taking proton pump inhibitors ≤ 14 days before registration
- Participating in another investigational drug trial while on study
- Pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErlotinibAlso: Tarceva, OSI-774continuous oral Erlotinib 85 mg/m^2 per day | Drug | Erlotinib |
Primary outcome
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
Time frame: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)
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.
2 secondary outcomes
Best Overall Response
Time frame: End of treatment (The mean treatment duration was 170.5 days.)
Median Treatment Duration
Time frame: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Astellas Pharma Global Development
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib in people with Ependymoma, run by OSI Pharmaceuticals at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs) (time frame: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.