Trial · NCT00932451
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
NCT00932451, Phase 2, Completed, Pfizer; results first posted 2016-06-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene. Trials, record NCT00932451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00932451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
- NCT number
- NCT00932451
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,069 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- PF-02341066
- First posted
- 2009-07-03
- Last updated
- 2017-01-13
- Other registries' IDs
- eudract:2009-012504-13
- Results first posted
- 2016-06-09
- Limitations and caveats
Pharmacogenetic analysis of renal adverse events was not performed as no gene alleles have been identified in published literature with statistically significant association with renal toxicity to support a case control association analysis.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 6 years | The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy. |
| Primary | Percentage of Participants With Adverse Events | 6 years | Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.0). |
| Secondary | Duration of Response (DR) | 6 years | DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4. |
| Secondary | Time to Tumor Response (TTR) | 6 years | TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. |
| Secondary | Disease Control Rate (DCR) | 6 years | DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively. |
| Secondary | Progression Free Survival (PFS) | 6 years | PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | 6 years | OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4. |
| Secondary | Probability of Survival | 6 years | Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate. |
| Secondary | Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182 | 6 years | Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation. |
| Secondary | Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) | 6 years | Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Duration of Response (DR) | 6 years | Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment. | Months | MEDIAN |
| SECONDARY | Time to Tumor Response (TTR) | 6 years | Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment. | Weeks | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | 6 years | Response-evaluable populations: defined as participants in either the SA-ALK positive by IUO population or SA-ALK positive by non-IUO population, respectively, who had adequate baseline tumor assessment. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | 6 years | The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic \[PK\] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 6 years | The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic \[PK\] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively. | Months | MEDIAN |
| SECONDARY | Probability of Survival | 6 years | The safety analysis populations included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic \[PK\] dosing), and were ALK positive either by IUO (SA-ALK positive by IUO population) or by non-IUO (SA-ALK positive by non-IUO population), respectively. | Percentage of probability | NUMBER |
| SECONDARY | Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182 | 6 years | All participants who have ≥ 1 measurement of PF-02341066 or PF-06260182 at the time of reporting are included in PK analysis. Concentration at Cycle 2 Day 1 and beyond are considered steady state, and only included those who received at least 14 continuous days of 250 mg BID dosing. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) | 6 years | The safety analysis population included all participants who received at least 1 dose of study medication (excluding day-7 pharmacokinetic \[PK\] dosing) and were ALK positive by IUO (SA-ALK positive by IUO population) | Percentage of cells | MEDIAN |
| SECONDARY | Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population) | 6 years | The All Genotyped Population was defined as all participants in the safety analysis population who had at least 1 genotype result. The Pharmacogenomic Evaluable (PE) Population was defined as participants in the All Genotyped Population who had an HLA genotype result and were designated as an ALT Case or Control. | Percentage of participants | NUMBER |
| SECONDARY | QTc Prolongation in Participants | 6 years | Participants from the SA population who had a Baseline (last ECG \[electrocardiogram\] prior to Cycle 1 Day 1 dose) and ≥1 post Baseline ECG measurement and were not included in the ECG sub-study. | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group892
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Response (DR) | Crizotinib 250 mg BID | ALK Positive by IUO, N=491 | 11.8 | 95% Confidence Interval 10.4 to 12.8 | Months |
| Duration of Response (DR) | Crizotinib 250 mg BID | ALK Positive by non-IUO only, N=64 | 9.5 | 95% Confidence Interval 6.9 to 15.2 | Months |
| Time to Tumor Response (TTR) | Crizotinib 250 mg BID | ALK Positive by IUO (n=491) | 6.1 | Full Range 2.7 to 164 | Weeks |
| Time to Tumor Response (TTR) | Crizotinib 250 mg BID | ALK Positive by non-IUO only (n=64) | 6.3 | Full Range 4.7 to 65.9 | Weeks |
| Disease Control Rate (DCR) | Crizotinib 250 mg BID | ALK Positive by IUO at Week 6, N=908 | 81.7 | 95% Confidence Interval 79.0 to 84.2 | Percentage of participants |
| Disease Control Rate (DCR) | Crizotinib 250 mg BID | ALK Positive by IUO at Week 12, N=908 | 70.8 | 95% Confidence Interval 67.7 to 73.8 | Percentage of participants |
| Disease Control Rate (DCR) | Crizotinib 250 mg BID | ALK Positive by non-IUO at Week 6, N=158 | 69.6 | 95% Confidence Interval 61.8 to 76.7 | Percentage of participants |
| Disease Control Rate (DCR) | Crizotinib 250 mg BID | ALK Positive by non-IUO at Week 12, N=158 | 61.4 | 95% Confidence Interval 53.3 to 69.0 | Percentage of participants |
| Progression Free Survival (PFS) | Crizotinib 250 mg BID | ALK Positive by IUO , N= 908 | 8.4 | 95% Confidence Interval 7.1 to 9.7 | Months |
| Progression Free Survival (PFS) | Crizotinib 250 mg BID | ALK Positive by non-IUO only , N=158 | 6.9 | 95% Confidence Interval 5.6 to 9.4 | Months |
1 to 10 of 892Source ClinicalTrials.gov
See all 892 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizotinib 250 mg BID | 1,066 | |
| Overall Study | COMPLETED | Crizotinib 250 mg BID | 244 | |
| Overall Study | NOT COMPLETED | Crizotinib 250 mg BID | 822 |
Source ClinicalTrials.gov
Adverse events365
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 | Crizotinib 250 mg BID | 138 | 1,066 | |
| other | Leukopenia | Blood and lymphatic system disorders | Crizotinib 250 mg BID | 101 | 1,066 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Crizotinib 250 mg BID | 71 | 1,066 | |
| other | Neutropenia | Blood and lymphatic system disorders | Crizotinib 250 mg BID | 180 | 1,066 | |
| other | Bradycardia | Cardiac disorders | Crizotinib 250 mg BID | 93 | 1,006 | |
| other | Photopsia | Eye disorders | Crizotinib 250 mg BID | 96 | 1,066 | |
| other | Vision blurred | Eye disorders | Crizotinib 250 mg BID | 80 | 1,066 | |
| other | Visual impairment | Eye disorders | Crizotinib 250 mg BID | 460 | 1,066 | |
| other | Abdominal pain | Gastrointestinal disorders | Crizotinib 250 mg BID | 118 | 1,066 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Crizotinib 250 mg BID | 106 | 1,066 |
1 to 10 of 365Source ClinicalTrials.gov
See all 365 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib 250 mg BID | ||
| Total, other adverse events | Crizotinib 250 mg BID | 1,038 | 1,066 |
| Total, serious adverse events | Crizotinib 250 mg BID | 539 | 1,066 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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