TriangleNCT00112736 · STUDY IN CONTEXT
Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed. 3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg
Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade \>/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy. MTD defined as dose at which fewer than one-third of patients experienced a DLT Outcome measure defines number of participants who had a defined dose limiting toxicity.
pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan. Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): \>= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).
Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1 Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer). Responses had to be present on 2 consecutive scans and were centrally reviewed.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- trial label
- Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0000
- source section id
- NCT00112736-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (Phase I)
- endpoint definition
- Oral erlotinab at 150mg constant dose, 3 pts will be treated with temsirolimus IV with escalating doses, starting at 50mg. Doses will increase or decrease based on toxicity observed. 3 pts will be treated at each dose level - 3 dose levels were observed: 50mg, 25mg, and 15mg
- time origin
- based on first 4 weeks of treatment - cycle 1
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Per protocol -
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0001
- source section id
- NCT00112736-om-0001
- source outcome index
- 1
- endpoint
- Safety/Dose Limiting Toxities Phase I
- endpoint definition
- Dose limiting toxities defined as: grade 3 thrombocytopenia, grade 4 anemia and neutropenia, grade \>/= nonhematologic toxicity, and failure to recover from toxicites to be eligible for retreatment in 2 weeks of the last dose of either drug. Also grade 3 nonhematologic toxicities only if they wre refractory to maxiaml medical therapy. MTD defined as dose at which fewer than one-third of patients experienced a DLT Outcome measure defines number of participants who had a defined dose limiting toxicity.
- time origin
- first 4 weeks of treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0002
- source section id
- NCT00112736-om-0002
- source outcome index
- 2
- endpoint
- Efficacy - Response Phase 1
- endpoint definition
- pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan. Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): \>= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).
- time origin
- at least 8 weeks of treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0003
- source section id
- NCT00112736-om-0003
- source outcome index
- 3
- endpoint
- Pharmacokinetics (Phase I)
- endpoint definition
- Tersirolimus Cmax (ng/mL) for cycle 1 is presented in the outcome measure table below for the 3 dose levels blood samples (5ml) was collected in EDTA containing tubes on days 1 and 2 of cycle 1 Collection time points: prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
- time origin
- Days 1, 2 of cycle 1, prior to dosing of both drugs, at end of temsirolimus infusion and at 1,2,4,6, and 24 hr after erlotinib administration
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- per protocol
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0004
- source section id
- NCT00112736-om-0004
- source outcome index
- 4
- endpoint
- Progression-free Survival at 6 Months (Phase II)
- endpoint definition
- Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer). Responses had to be present on 2 consecutive scans and were centrally reviewed.
- time origin
- Evaluated at baseline and every other cycle, till Month 6
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Primary endpoint PFS6 date of registration; Sample size chosen to discriminate between 15% \& 35% PFS6 rates for GBM patients. With accrual 32 GBM patients, trial would be considered successful if 8 achieved PFS6. This yields 0.92 power to detect a 35% PFS6 rate, with 0.90 probability of rejecting the treatment regimen if the PFS6 rate is only 15%.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase I - Dose Escalation
- regimen
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity. Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase 1 - 50mg
- regimen
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase 1 - 25 mg
- regimen
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Phase 1 - 15mg
- regimen
- PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase I 15mg Temsirolimus (MTD Dose)
- regimen
- PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase 1 - 15mg
- regimen
- PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Phase 1 - 25 mg
- regimen
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Phase 1 - 50mg
- regimen
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Phase II n=43
- regimen
- Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. Glioblastoma erlotinib: Given orally temsirolimus: Given IV
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00112736-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- harm key
- EG000
- source section id
- NCT00112736-ae
- event group key
- EG000
- event group label
- Phase I (Erlotinib & Temsirolimus)
- serious affected
- 3
- serious at risk
- 21
- other affected
- 21
- other at risk
- 21
- frequency threshold
- 0
- collection period
- Adverse Events were collected weekly for the first cycle and then at the start of each cycle while on treatment and at time of off study.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-adult-giant-cell-glioblastoma
- nct id
- NCT00112736
- harm key
- EG001
- source section id
- NCT00112736-ae
- event group key
- EG001
- event group label
- Phase II (Erlotinib & Erlotinib)
- serious affected
- 2
- serious at risk
- 59
- other affected
- 37
- other at risk
- 59
- frequency threshold
- 0
- collection period
- Adverse Events were collected weekly for the first cycle and then at the start of each cycle while on treatment and at time of off study.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice