Trial · NCT00585195
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
NCT00585195, Phase 1, Completed, Pfizer; results first posted 2021-10-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer. Trials, record NCT00585195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00585195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
- NCT number
- NCT00585195
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 596 participants, actual
- Lead sponsor
- Pfizer
- Conditions
Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent, Non-Small Cell Lung Cancer ROS Marker Positive, Systemic Anaplastic Large-Cell Lymphoma, Advanced Malignancies Except Leukemia
- Interventions
- PF-02341066, Rifampin, Itraconazole
- First posted
- 2008-01-03
- Last updated
- 2023-02-08
- Results first posted
- 2021-10-14
Source ClinicalTrials.gov
Registered outcomes53
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Cycle 1 (28 days) | MTD: Dose level at which at most 1 of 6 participants experienced DLT within and including 28 days of treatment (during Cycle 1 \[1 cycle=28 days\]) with next higher dose having at least 2/3 or 2/6 participants experiencing a DLT. DLT was defined as any of following: Hematologic toxicities- 1) prolonged grade 4 neutropenia for \>7 days. 2) Febrile neutropenia: grade 4 neutropenia with fever greater than (\>) 38.5 degree Celsius, both sustained over a 24 hour period (3) neutropenic infection: greater than or equal to (\>=) Grade 3 neutropenia with Grade \>=3 infection. (4) Grade \>=3 thrombocytopenia with bleeding/grade 4 lasting \>=7 days. Other non-hematologic toxicity included: Grade 3/4 toxicities (except for alopecia, Grade 3/4 hypophosphatemia, grade 3 hypertension with controlled blood pressure \[less than (\<) 140/90 millimeter of mercury, and Grade 3/4 hyperuricemia without signs and symptoms of gout). Nausea, vomiting/diarrhea must persist at grade 3/4 despite maximal medical therapy. |
| Primary | Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib | Cycle 1 (28 days) | RP2D was defined as a dose below or equal to MTD, at which crizotinib was unlikely to cause a significant inhibition of CYP3A4 activity. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7 | Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (0-inf). |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Day -7 | Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7 | Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 1 | Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1 | Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 15 | Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 | Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 2 Day 1 | Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1 | Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 hours for BID dose and 24 hours for QD dose. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib Cycle 1 Day 15 | Pre-dose on Cycle 1 Day 15 | Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib on Cycle 2 Day 1 | Pre-dose on Cycle 2 Day 1 | Ctrough refers to plasma concentration of Crizotinib observed just before treatment administration. |
| Primary | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Day -7 | Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7 | Cmax is defined as the observed maximum plasma concentration post drug administration. |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 registered outcomesOutcomes53
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Cycle 1 (28 days) | Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. | milligram | NUMBER |
| PRIMARY | Dose-Escalation Cohort: Recommended Phase 2 Dose (RP2D) of Crizotinib | Cycle 1 (28 days) | Safety analysis (SA) set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. | milligram | NUMBER |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Crizotinib on Day -7 | Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7 | Pharmacokinetic (PK) parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Overall number of participants analyzed (N) signifies participants evaluable for this outcome measure (OM). Data for this OM was planned to be collected for individual arms of low and high dose escalation and combined RP2D Cohort excluding Low Dose Escalation Cohort: Crizotinib 100 mg QD arm. | nanogram*hour per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Day -7 | Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7 | PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, N signifies participants evaluable for this OM. Data for this OM was planned to be reported for individual arms of low and high dose escalation and combined RP2D Cohort excluding Low Dose Escalation Cohort: Crizotinib 100 mg QD arm. | nanogram*hour per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 1 | Pre-dose, 2, 4 and 6 hours post dose on Cycle 1 Day 1 | PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, N signifies participants evaluable for this OM. Data for this OM was planned to be collected for low dose escalation cohort (excluding Crizotinib 50 mg QD, Crizotinib 200 mg QD and Crizotinib 250 mg BID arms) and combined RP2D cohort and was not planned to be collected for high dose escalation cohort. | nanogram*hour per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 1 Day 15 | Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 1 Day 15 | The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, Overall number of participants analyzed signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts and combined RP2D Cohort. | nanogram*hour per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib on Cycle 2 Day 1 | Pre-dose, 1, 2, 4, 6, 8, 9 and 24 hours post dose on Cycle 2 Day 1 | The PK parameter analysis population included all participants treated (including Day -7 dose) who have at least 1 of the PK parameters of interest for Crizotinib. Here, Overall number of participants analyzed signifies number of participants evaluable for this outcome measure. Data for this outcome measures was planned to be collected for individual arms of dose escalation cohorts and combined RP2D Cohort. | nanogram*hour per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib Cycle 1 Day 15 | Pre-dose on Cycle 1 Day 15 | PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, N signifies participants evaluable for this OM. Data for this OM was planned to be collected for individual arms of low dose escalation and combined RP2D Cohort and not planned to be collected for high dose escalation cohort. | nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Trough Concentration (Ctrough) of Crizotinib on Cycle 2 Day 1 | Pre-dose on Cycle 2 Day 1 | PK parameter analysis population included all participants treated (including Day -7 dose) who had at least 1 of the PK parameters of interest for Crizotinib. Here, N signifies participants evaluable for this OM. Data for this OM was planned to be collected for individual arms of low dose escalation and combined RP2D Cohort and not planned to be collected for high dose escalation cohort. | nanogram per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Dose-Escalation and Recommended Phase 2 Dose (RP2D) Cohort: Maximum Observed Plasma Concentration (Cmax) of Crizotinib on Day -7 | Pre-dose, 1, 2, 4, 6, 8, 9, 24, 48 and any two time points (72, 96, 120 and 144 hours) post-dose on Day -7 | PK parameter analysis population set. N=participants evaluable for this outcome measure. Data for this OM was planned to be collected for dose escalation cohorts (both low and high) and combined RP2D Cohort excluding Low Dose Escalation Cohort: Crizotinib 100 mg QD cohort arms. | nanogram per milliliter | GEOMETRIC_MEAN |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 outcomesResults by group400
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Low Dose Escalation Cohort: Crizotinib 50 mg QD | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Low Dose Escalation Cohort: Crizotinib 100 mg QD | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Low Dose Escalation Cohort: Crizotinib 200 mg QD | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Low Dose Escalation Cohort: Crizotinib 200 mg BID | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Low Dose Escalation Cohort: Crizotinib 250 mg BID | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | Low Dose Escalation Cohort: Crizotinib 300 mg BID | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | High Dose Escalation Cohort: Crizotinib 300 mg QD | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | High Dose Escalation Cohort: Crizotinib 400 mg QD | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | High Dose Escalation Cohort: Crizotinib 500 mg QD | 250 | milligram | ||
| Dose-Escalation Cohort: Maximum Tolerated Dose (MTD) of Crizotinib | High Dose Escalation Cohort: Crizotinib 650 mg QD | 250 | milligram |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Escalation Cohort: Crizotinib 50 mg QD | 3 | |
| Overall Study | STARTED | Low Dose Escalation Cohort: Crizotinib 100 mg QD | 4 | |
| Overall Study | STARTED | Low Dose Escalation Cohort: Crizotinib 200 mg QD | 9 | |
| Overall Study | STARTED | Low Dose Escalation Cohort: Crizotinib 200 mg BID | 7 | |
| Overall Study | STARTED | Low Dose Escalation Cohort: Crizotinib 250 mg BID | 9 | |
| Overall Study | STARTED | Low Dose Escalation Cohort: Crizotinib 300 mg BID | 6 | |
| Overall Study | STARTED | High Dose Escalation Cohort: Crizotinib 300 mg QD | 7 | |
| Overall Study | STARTED | High Dose Escalation Cohort: Crizotinib 400 mg QD | 5 | |
| Overall Study | STARTED | High Dose Escalation Cohort: Crizotinib 500 mg QD | 3 | |
| Overall Study | STARTED | High Dose Escalation Cohort: Crizotinib 650 mg QD | 6 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events11,550
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 | Low Dose Escalation Cohort: Crizotinib 50 mg QD | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose Escalation Cohort: Crizotinib 100 mg QD | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose Escalation Cohort: Crizotinib 200 mg QD | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose Escalation Cohort: Crizotinib 200 mg BID | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose Escalation Cohort: Crizotinib 250 mg BID | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Low Dose Escalation Cohort: Crizotinib 300 mg BID | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | High Dose Escalation Cohort: Crizotinib 300 mg QD | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | High Dose Escalation Cohort: Crizotinib 400 mg QD | 1 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | High Dose Escalation Cohort: Crizotinib 500 mg QD | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | High Dose Escalation Cohort: Crizotinib 650 mg QD | 1 | 6 |
1 to 10 of 11,550Source ClinicalTrials.gov
See all 11,550 adverse eventsAdverse event totals63
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Escalation Cohort: Crizotinib 50 mg QD | 0 | 3 |
| Total, all-cause mortality | Low Dose Escalation Cohort: Crizotinib 100 mg QD | 0 | 4 |
| Total, all-cause mortality | Low Dose Escalation Cohort: Crizotinib 200 mg QD | 0 | 8 |
| Total, all-cause mortality | Low Dose Escalation Cohort: Crizotinib 200 mg BID | 0 | 7 |
| Total, all-cause mortality | Low Dose Escalation Cohort: Crizotinib 250 mg BID | 0 | 8 |
| Total, all-cause mortality | Low Dose Escalation Cohort: Crizotinib 300 mg BID | 0 | 6 |
| Total, all-cause mortality | High Dose Escalation Cohort: Crizotinib 300 mg QD | 1 | 6 |
| Total, all-cause mortality | High Dose Escalation Cohort: Crizotinib 400 mg QD | 0 | 5 |
| Total, all-cause mortality | High Dose Escalation Cohort: Crizotinib 500 mg QD | 1 | 3 |
| Total, all-cause mortality | High Dose Escalation Cohort: Crizotinib 650 mg QD | 1 | 6 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse event totalsPapers18
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.
GET https://conductscience.org/api/trials/v1/NCT00585195
GET https://conductscience.org/api/trials/v1/NCT00585195/registered?page=2