Trial · NCT00045110
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Dose Limiting Toxicity (DLT) Each Dose Level Phase I | 28 days | DLT Definition: any grade 3 thrombocytopenia and grade 4 anemia and neutropenia; any non-hematologic grade 3 toxicity; failure to recover from toxicities to be eligible for re-treatment with erlotinib within 2 weeks of the last dose of erlotinib. |
| Primary | Define Maximum Tolerated Dose (MTD) of Erlotinib by Phase 1 Cohorts | cycle 1 - 28 days | standard 3+3 dose escalation design 3 patients in each dose level, observed for 28 days before enrollment to next level. if none of the patients experienced DLT dose escalated, if 1 of 3 experienced DLT 3 more enrolled at that level, if none of the 3 additional pts had DLT escalate to next level, if one or more of the additional pts experienced DLT, the MTD was exceeded and 3 more patients were treated at the next lower dose (if only 3 pts treated at the lower dose). The MTD is the dose at which 0/3 or 1/6 patients have experienced a DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT. |
| Primary | 6 Months Progression-free Survival in Recurrent Malignant Gliomas (Phase II) | 6 months | Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). |
| Secondary | Percent of Participants With a Grade 3 or 4 Adverse Events Phase 1 | 1 year | CTCAE |
| Secondary | 1 Year Survival - Phase II Newly Diagnosed GBM Post RT | At 1 year | 12 month survival for newly diagnosed stable GBM post RT treated with erlotinib post RT |
| Secondary | Overall Survival Newly Diagnosed GBM Post RT | 2 years | Overall Survival defined as Time from Start of treatment to time of death due to any cause |
| Secondary | Response Rate (Complete or Partial Response) Graded Using Modified RECIST Criteria Phase II | At 1 year | Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). |
| Secondary | Percent of Patients With One or More Grade 3-5 Toxicity Described Based on the CTC Severity Grading Phase II | Up to 1 year | Summarized by descriptive statistics. |
| Secondary | Time of Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) - | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Peak Plasma Concentration Per Dose Level Phase I (on Anticonvulsants) - | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Estimation of the Area Under the Curve Per Dose Level Phase I (on Anticonvulsants) - | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Trough Level Per Dose Level Phase I (on Anticonvulsants) - | cycle 1 day eight | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Peak Plasma Concentration Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Time to Peak Plasma Concentration for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Estimation of Area Under the Curve for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg- | baseline, 1,2,4,6,8,12,24h post administration day 1 cycle 1. One sample on day 8 cycle 1 and day 1 of cycle 2,3 and 5 | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Trough Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs - Phase 2 - Dose 150mg - | One sample on day 8 cycle 1 | plasma concentrations relative to erlotiniab administration and sample time and dose level |
| Secondary | Pharmacokinetics (Plasma) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs | Pre-surgery and time of resection | Drug administered 6 days prior to surgery |
| Secondary | Pharmacokinetics (Tissue) Level for Recurrent Patients Not on Enzyme-inducing Antiepileptic Drugs | Pre-surgery and time of resection | Drug administered 6 days prior to surgery |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT00045110/registered