Trial · NCT00965731
Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
NCT00965731, Phase 1, Completed, Pfizer; results first posted 2013-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer. Trials, record NCT00965731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
- NCT number
- NCT00965731
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 27 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Erlotinib, Erlotinib, PF-02341066
- First posted
- 2009-08-26
- Last updated
- 2015-10-28
- Other registries' IDs
- eudract:2009-012377-35
- Results first posted
- 2013-01-14
- Limitations and caveats
The sponsor terminated phase 2 of this study; no data was collected during phase 2, leading to phase 2 outcomes not analyzed. The decision was based on strategic considerations regarding the clinical program only; there were no safety concerns.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | Baseline up to Day 28 | 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). |
| Primary | Progression-Free Survival (Phase 2) | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity | Time in weeks from phase 2 study randomization to first documentation of objective disease progression or death due to any cause. Progression-Free Survival was calculated as (first event date minus randomization date plus 1) divided by 7.02. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from AE data (where the outcome was "Death"; date of death reported in notice of death was used). |
| Secondary | PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | AUCtau is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle1 Day 15) of PF-02341066 were administered in combination of Erlotinib. |
| Secondary | PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Cmax is a measure of the plasma exposure to PF-02341066. In this study, it is used to characterize PF-02341066 exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib |
| Secondary | PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1) | C1D15 i.e., 15 days of giving crizotinib and erlotinib | Apparent oral Clearance is a measure of combination of the rate at which a drug is removed from the blood (CL) and the bioavailability (F) after oral dose. In this study, It is used to characterize PF-02341066 CL/F after multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. |
| Secondary | PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | AUCtau is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. |
| Secondary | PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Cmax is a measure of the plasma exposure to PF-06260182, a PF-02341066 metabolite. In this study, it is used to characterize the metabolite exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. |
| Secondary | Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Molecular weight adjusted PF-06260182-to-PF-02341006 ratio of AUCtau is a measure of how much PF-02341066 (parent drug) was converted to the metabolite PF-06260182 after PF-02341066 dosing. In this study, it is used to characterize the metabolite-to-parent ratio exposure after a single dose (Cycle 1 Day 1) and multiple doses (Cycle 1 Day 15) of PF-02341066 were administered in combination of Erlotinib. |
| Secondary | Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | AUCtau is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15). |
| Secondary | Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Cmax is a measure of the plasma exposure to erlotinib. In this study, it is used to characterize erlotinib exposure after multiple doses of erlotinib were administered alone (Day -1) and in combination of PF-02341066 (Cycle 1 Day 1 and Day 15). |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | Baseline up to Day 28 | 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) | participants | NUMBER |
| PRIMARY | Progression-Free Survival (Phase 2) | Baseline, every 42 days up to 20 months, disease progression, or unacceptable toxicity | Not analyzed due to phase 2 study termination | ||
| SECONDARY | PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | Cycle 1 (C1) Day 1 (D1) i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-02341066 (Crizotinib) Apparent Oral Clearance (CL/F) (Phase 1) | C1D15 i.e., 15 days of giving crizotinib and erlotinib | The pharmacokinetic (PK) parameter analysis population was defined as all participants in the safety analysis set 1 who had at least 1 of the PK parameters of interest. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | PF-06260182 Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | PF-06260182 Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Molecular Weight Adjusted PF-06260182-to-PF-02341006 Ratio of AUCtau (Phase 1) | C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Erlotinib Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Erlotinib Maximum Observed Plasma Concentration (Cmax) (Phase 1) | C1D-1 i.e., 1 day prior to initiation of continuous dosing of crizotinib; C1D1 i.e., 1 day of giving crizotinib and erlotinib; and C1D15, i.e., 15 days of giving crizotinib and erlotinib | Pharmacokinetic (PK) parameter analysis population included all participants in safety analysis set 1 who had at least 1 of the PK parameters of interest. Number of participants analyzed section in below table includes number of participants in PK analysis population. N=number of participants in treatment group contributing to summary statistics. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | PF-02341066 (200 mg) and Erlotinib (100 mg) | 2 | participants | ||
| Number of Participants With Dose-Limiting Toxicities (DLT) (Phase 1) | PF-02341066 (150 mg) and Erlotinib (100 mg) | 3 | participants | ||
| PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | PF-02341066 (200 mg) and Erlotinib (100 mg) | C1D1 Crizotinib (N=7, 19) | 581.9 | Geometric Coefficient of Variation 49 | ng*hr/mL |
| PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | PF-02341066 (150 mg) and Erlotinib (100 mg) | C1D1 Crizotinib (N=7, 19) | 400.3 | Geometric Coefficient of Variation 40 | ng*hr/mL |
| PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | PF-02341066 (200 mg) and Erlotinib (100 mg) | C1D15 Crizotinib (N=5, 14) | 2274 | Geometric Coefficient of Variation 43 | ng*hr/mL |
| PF-02341066 (Crizotinib) Area Under the Concentration-Time Curve During Dosing Interval (AUCtau) (Phase 1) | PF-02341066 (150 mg) and Erlotinib (100 mg) | C1D15 Crizotinib (N=5, 14) | 1720 | Geometric Coefficient of Variation 40 | ng*hr/mL |
| PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | PF-02341066 (200 mg) and Erlotinib (100 mg) | C1D1 Crizotinib (N=7, 19) | 86.75 | Geometric Coefficient of Variation 37 | ng/mL |
| PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | PF-02341066 (150 mg) and Erlotinib (100 mg) | C1D1 Crizotinib (N=7, 19) | 65.31 | Geometric Coefficient of Variation 50 | ng/mL |
| PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | PF-02341066 (200 mg) and Erlotinib (100 mg) | C1D15 Crizotinib (N=5, 14) | 251.0 | Geometric Coefficient of Variation 46 | ng/mL |
| PF-02341066 (Crizotinib) Maximum Observed Plasma Concentration (Cmax) (Phase 1) | PF-02341066 (150 mg) and Erlotinib (100 mg) | C1D15 Crizotinib (N=5, 14) | 185.9 | Geometric Coefficient of Variation 40 | ng/mL |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-02341066 (200 mg) and Erlotinib (100 mg) | 7 | |
| Overall Study | STARTED | PF-02341066 (150 mg) and Erlotinib (100 mg) | 20 | |
| Overall Study | COMPLETED | PF-02341066 (200 mg) and Erlotinib (100 mg) | 0 | |
| Overall Study | COMPLETED | PF-02341066 (150 mg) and Erlotinib (100 mg) | 0 | |
| Overall Study | NOT COMPLETED | PF-02341066 (200 mg) and Erlotinib (100 mg) | 7 | |
| Overall Study | NOT COMPLETED | PF-02341066 (150 mg) and Erlotinib (100 mg) | 20 |
Source ClinicalTrials.gov
Adverse events312
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PF-02341066 (200 mg) and Erlotinib (100 mg) | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-02341066 (150 mg) and Erlotinib (100 mg) | 3 | 20 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | PF-02341066 (200 mg) and Erlotinib (100 mg) | 0 | 7 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | PF-02341066 (150 mg) and Erlotinib (100 mg) | 1 | 20 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-02341066 (200 mg) and Erlotinib (100 mg) | 0 | 7 | |
| other | Neutropenia | Blood and lymphatic system disorders | PF-02341066 (150 mg) and Erlotinib (100 mg) | 1 | 20 | |
| other | Pericardial effusion | Cardiac disorders | PF-02341066 (200 mg) and Erlotinib (100 mg) | 1 | 7 | |
| other | Pericardial effusion | Cardiac disorders | PF-02341066 (150 mg) and Erlotinib (100 mg) | 0 | 20 | |
| other | Tachycardia | Cardiac disorders | PF-02341066 (200 mg) and Erlotinib (100 mg) | 0 | 7 | |
| other | Tachycardia | Cardiac disorders | PF-02341066 (150 mg) and Erlotinib (100 mg) | 1 | 20 |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-02341066 (200 mg) and Erlotinib (100 mg) | ||
| Total, all-cause mortality | PF-02341066 (150 mg) and Erlotinib (100 mg) | ||
| Total, other adverse events | PF-02341066 (200 mg) and Erlotinib (100 mg) | 7 | 7 |
| Total, other adverse events | PF-02341066 (150 mg) and Erlotinib (100 mg) | 19 | 20 |
| Total, serious adverse events | PF-02341066 (200 mg) and Erlotinib (100 mg) | 2 | 7 |
| Total, serious adverse events | PF-02341066 (150 mg) and Erlotinib (100 mg) | 8 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| PF-02341066 (200 mg) and Erlotinib (100 mg) vs PF-02341066 (150 mg) and Erlotinib (100 mg): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00965731
GET https://conductscience.org/api/trials/v1/NCT00965731/registered?page=2