AstrocytomaPhase 2NCT00783393
SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)
A Phase 2 study testing Temozolomide in people with Astrocytoma, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma
- What is being tested?
- Temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2003to 17 Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at first relapse, and satisfy the following:
- unequivocal evidence of tumor recurrence or aggravation by MRI scan after treatment for initial onset; the lesions must be measurable;
- anaplastic astrocytoma diagnosed histologically by the last pathological diagnostic tests (including initial diagnosis) prior to initial administration of temozolomide;
- tissue samples available for Central Pathologic Reviewer;
- pathologic diagnosis report by the study-conducting medical institution must be available for the sponsor.
- MRI-related criteria:
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- MRI scan performed within 14 days before initial temozolomide administration;
- assessable tumor site confirmed by MRI;
- dosage of steroidal agents not increased within 7 days before MRI prior to initial temozolomide administration, except for postoperative subjects for first relapse;
- MRI performed at the Principal Investigator's study location or designated radiology facility during the study.
- Age >=18 years, either sex, inpatients or outpatients.
- Use of medically approved contraception methods in fertile subjects.
- Karnofsky performance status >=70.
- Adequate clinically laboratory values obtained within 14 days before initial temozolomide administration.
- Criteria regarding treatment of initial onset:
- tumor biopsy, regardless of tumor resection at initial diagnosis;
- prior radiation therapy;
- prior chemotherapy with up to one nitrosourea-containing regimen.
- Tumor may or may not have been surgically resected at first relapse, but residual measurable disease is required.
- For subjects who had surgical resection of tumor at first relapse:
- MRI scan must have been performed within 72 hours after surgery.
- the dose of steroidal agents must be reduced before temozolomide administration.
- Life expectancy >=12 weeks.
- Written informed consent obtained.
Who cannot join
- History of treatment with dacarbazine.
- Subjects who received chemotherapy within 6 weeks before initial temozolomide administration.
- Subjects who received interstitial radiotherapy or stereotactic radiosurgery.
- Subjects who completed radiotherapy within 12 weeks before initial temozolomide administration.
- Surgery at first relapse (including biopsy) within 1 week before initial temozolomide administration.
- Subjects not recovered from acute toxicity due to previous therapy.
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- High-risk subjects with complication of diseases other than malignant tumor, or who require systemic administration of antibiotics for infection.
- Previous or concurrent malignancies at other sites.
- Pregnant or nursing women.
- Women of childbearing potential not using an effective method of contraception.
- Subjects previously treated with temozolomide.
- Participation in an ongoing clinical study, or in other clinical studies within 6 months before initial temozolomide administration.
- Subjects found inappropriate for the study by the investigator or subinvestigator.
About this study
Official title: SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma
The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.
- Conditions
- Astrocytoma
- Being tested
- Temozolomide
- Medical subject headings
- Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodal, Temodar, SCH 052365
Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | The study consists of two steps:
* Step 1, the therapeutic study phase, comprising six cycles of treatment with temozolomide, and
* Step 2, the long-term treatment phase, where subjects with at least disease stabilization at the end of Step 1 may continue temozolomide treatment until unacceptable toxicity or disease progression occur, up to a maximum of 2 years from the start of treatment in Cycle 1. Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response in Step 1
Measured: 6 months
Incidence rate and severity of adverse events with administration of temozolomide in Step 1
Measured: 7 months (during temozolomide administration for 6 months and follow-up for 1 month)
Secondary outcomes (10)
Progression-free survival in Step 1
Measured: 6 months
Overall survival in Step 1
Measured: 6 months
Tumor response in Step 1
Measured: 6 months
Neurological improvement in Step 1
Measured: 6 months
Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2
Measured: 6 months
Progression-free survival in Step 2
Measured: Up to 2 years
Overall survival in Step 2
Measured: Up to 2 years
Overall response in Step 2
Measured: Up to 2 years
Effect on neurological symptoms in Step 2
Measured: Up to 2 years
Safety in Step 2
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start27 May 2003
- Primary completion17 Jun 2005
- Study completion17 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783393
- Sponsor's protocol ID
- P03745
- Other IDs
- JPC02-351-21
- Status last verified
- May 2017
- First submitted
- 30 Oct 2008
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma
- ClinicalTrials.gov ID
- NCT00783393
- Acronym / sponsor ID
- P03745
- Conditions
- Astrocytoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 27 May 2003 (actual)
- Primary completion
- 17 Jun 2005 (actual)
- Study completion
- 17 Jun 2005 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the efficacy (overall response) and safety of temozolomide in Step 1 at the dose and regimen approved in the US and the EU countries (28 day cycles of temozolomide at 150 to 200 mg/m2 once daily for 5 consecutive days with a 23 day rest period) in patients with anaplastic astrocytoma at first relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: TemozolomideThe study consists of two steps: * Step 1, the therapeutic study phase, comprising six cycles of treatment with temozolomide, and * Step 2, the long-term treatment phase, where subjects with at least disease stabilization at the end of Step 1 may continue temozolomide treatment until unacceptable toxicity or disease progression occur, up to a maximum of 2 years from the start of treatment in Cycle 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subject must have histologically confirmed anaplastic astrocytoma on the tentorium at first relapse, and satisfy the following:
- MRI-related criteria:
- Age >=18 years, either sex, inpatients or outpatients.
- Use of medically approved contraception methods in fertile subjects.
- Karnofsky performance status >=70.
Key exclusion criteria (13 listed)
- History of treatment with dacarbazine.
- Subjects who received chemotherapy within 6 weeks before initial temozolomide administration.
- Subjects who received interstitial radiotherapy or stereotactic radiosurgery.
- Subjects who completed radiotherapy within 12 weeks before initial temozolomide administration.
- Surgery at first relapse (including biopsy) within 1 week before initial temozolomide administration.
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 |
|---|---|---|
| TemozolomideAlso: Temodal, Temodar, SCH 052365Temozolomide orally once daily for 5 consecutive days followed by a 23 day rest period to complete a 28 day treatment cycle. In Cycle 1, temozolomide will be administered at 150 mg/m2/day; in Cycle 2 and subsequent cycles, it will be administered at 100, 150, or 200 mg/m2, depending on hematology test results and adverse events observed. | Drug | Single arm |
Primary outcome
Overall response in Step 1
Time frame: 6 months
Incidence rate and severity of adverse events with administration of temozolomide in Step 1
Time frame: 7 months (during temozolomide administration for 6 months and follow-up for 1 month)
10 secondary outcomes
Progression-free survival in Step 1
Time frame: 6 months
Overall survival in Step 1
Time frame: 6 months
Tumor response in Step 1
Time frame: 6 months
Neurological improvement in Step 1
Time frame: 6 months
Progression-free survival, overall survival, overall response, effect on neurological symptoms, and safety in Step 2
Time frame: 6 months
Progression-free survival in Step 2
Time frame: Up to 2 years
Overall survival in Step 2
Time frame: Up to 2 years
Overall response in Step 2
Time frame: Up to 2 years
Effect on neurological symptoms in Step 2
Time frame: Up to 2 years
Safety in Step 2
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Astrocytoma, run by Merck Sharp & Dohme LLC.
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 24 inclusion and 13 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: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall response in Step 1 (time frame: 6 months). The study lists 2 primary outcomes in all. 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 15 May 2017.