Comparison · NCT00965731-60773afd
PF-02341066 (200 mg) and Erlotinib (100 mg) vs PF-02341066 (150 mg) and Erlotinib (100 mg): Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. PF-02341066 (200 mg) and Erlotinib (100 mg) vs PF-02341066 (150 mg) and Erlotinib (100 mg): Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1). Trial comparisons, record NCT00965731-60773afd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00965731-60773afd
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk in group 2 | 0.188 | 0.0659 | 0.43 | wilson | |
| Risk difference, group 1 minus group 2 | 0.146 | -0.193 | 0.532 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.78 | 0.387 | 8.16 | log | |
| Odds ratio, group 1 over group 2 | 2.17 | 0.262 | 17.9 | log | |
| Number needed to treat, for one more participant with the outcome on PF-02341066 (200 mg) and Erlotinib (100 mg) than on PF-02341066 (150 mg) and Erlotinib (100 mg) | 6.86 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PF-02341066 (200 mg) and Erlotinib (100 mg) | PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. | 2 | 6 | OG000 |
| Group 2 | PF-02341066 (150 mg) and Erlotinib (100 mg) | PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD. | 3 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1)
- Description
Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 percent (%) of planned dose during cycle 1 due to possible drug-related adverse events (AEs).
- Time frame
- Baseline up to Day 28
- Population
DLT evaluable population: all participants in dose escalation phase receiving at least 1 dose of study medication who did not have a major treatment deviation during the first cycle (for example, less than 80% of planned dose of PF-02341066 or erlotinib in cycle 1 for reasons other than treatment-related toxicities)
Source ClinicalTrials.gov
Trial
- Title
- Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
- NCT number
- NCT00965731
- Phases
- PHASE1
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Erlotinib, Erlotinib, PF-02341066
- Lead sponsor
- Pfizer
- Results first posted
- 2013-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00965731?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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