Trial · NCT01970865
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
NCT01970865, Phase 1, Phase 2, Completed, Pfizer; results first posted 2018-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations. Trials, record NCT01970865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01970865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
- NCT number
- NCT01970865
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 364 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
- Interventions
- PF-06463922, Crizotinib
- First posted
- 2013-10-28
- Last updated
- 2024-08-12
- Other registries' IDs
- eudract:2013-002620-17
- Results first posted
- 2018-05-29
Source ClinicalTrials.gov
Registered outcomes73
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | Cycle 1 (21 days) | DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \>7 days; febrile neutropenia; grade\>=3 neutropenic infection; grade\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\>=3 pancreatitis; grade\>=3 toxicities (excluding grade \>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \>=3 QT interval corrected for heart rate (QTc) prolongation, or asymptomatic grade \>=3 prolongation that had been confirmed by repeat testing, re-evaluation by qualified person, persisted after correction of reversible causes; \>=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of 21 prescribed daily total dose due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicity attributable to study drug. |
| Primary | Percentage of Participants With Overall and Intracranial Objective Response (Phase 2) | 3 years | Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 milliliter (mm) on Target Lesions electronic case report form (eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 percent (%) or more decrease in sum of lesion dimensions (SLD) of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review. |
| Secondary | Percentage of Participants With Overall and Intracranial Objective Response (Phase 1) | From start of study treatment until CR or PR (maximum of 8 years approximately) | Objective response (OR) refers to confirmed CR or PR according to RECIST version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review. |
| Secondary | Time to Tumor Response (TTR) and Intracranial TTR (Phase 1) | From start of study treatment to the first documentation of objective tumor response (CR or PR) (maximum of 8 years approximately) | Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review. |
| Secondary | Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1) | From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately) | Duration of response(DOR): time from first documentation of objective tumor response (CR/PR) to first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. DOR: calculated for subgroup of participants with confirmed objective tumor response. Intracranial DOR: calculated for participants with confirmed intracranial objective response. CR:disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesion eCRF). Any pathological lymph node (recorded as target lesion) must have reduction in short axis to \<10mm. PR:30% or more decrease in SLD of target lesion, taking as reference baseline SLD. PD:20% or more increase in the SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition, also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose. |
| Secondary | Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1) | 12 and 24 weeks | Tumor response was evaluated according to RECIST version 1.1, and disease control: confirmed CR, confirmed PR, or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. CR was defined as disappearance of all non-lymph node target lesions (where all target lesions are recorded with length of 0mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as 30% or more decrease in SLD of target lesions, taking as reference baseline SLD. Progressive disease: 20% or more increase in SLD of target lesions relative to baseline or smallest SLD (nadir) recorded since first dose. In addition to relative increase of 20%, SLD must also demonstrate absolute increase of at least 5mm (\>=5mm) relative to baseline or smallest SLD (nadir) recorded since first dose. Results presented here were based on independent central review. |
| Secondary | Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1) | 3 years | The probability of the first event being a CNS progression, a non-CNS progression, or death was evaluated with a competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to the analysis set. The time to first event being a Competing Event (either "CNS progression" or "non CNS progression" or "Death") was defined as time from first dose until the date of that specific event. Participants not known to have any of the Competing Events were censored on the date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as a competing cause of failure for the analysis of other type of events. For each type of event, the cumulative incidence function corresponding to the nearest time point preceding 1 year is presented. The results are based on independent central review. |
| Secondary | Progression-Free Survival (PFS) (Phase 1) | From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately) | PFS was defined as the time from the first dose of study treatment to the first documentation of objective PD or to death on study due to any cause, whichever came first. Progressive disease was defined by a 20% or more increase in the SLD of target lesions relative to baseline or the smallest SLD (nadir) recorded since first dose. In addition to the relative increase of 20%, SLD must also demonstrate an absolute increase of at least 5 mm (\>= 5 mm) relative to baseline or the smallest SLD (nadir) recorded since the first dose. Results presented here were based on independent central review. |
| Secondary | Overall Survival (OS) (Phase 1) | 3 years | OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups. | Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data. |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 registered outcomesOutcomes73
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 Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | Cycle 1 (21 days) | Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD. Here, Overall Number Analyzed signifies participants analyzed for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Overall and Intracranial Objective Response (Phase 2) | 3 years | The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with central nervous system (CNS) metastases in the ITT analysis set were used for intracranial response assessment. Here, Number Analyzed signifies participants evaluable for specified rows. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall and Intracranial Objective Response (Phase 1) | From start of study treatment until CR or PR (maximum of 8 years approximately) | The ITT analysis set was used for overall response assessment and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment. Here, Number Analyzed signifies participants analyzed for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) and Intracranial TTR (Phase 1) | From start of study treatment to the first documentation of objective tumor response (CR or PR) (maximum of 8 years approximately) | TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. | Months | MEDIAN |
| SECONDARY | Number of Participants With Duration of Response (DOR) and Intracranial DOR (Phase 1) | From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately) | DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data foe every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 and 24 Weeks (Phase 1) | 12 and 24 weeks | The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment. | Percentage of participants | NUMBER |
| SECONDARY | Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1) | 3 years | The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. | Probability of events | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) (Phase 1) | From start of study treatment to first documentation of PD or to death due to any cause, whichever occurred first (maximum of 8 years approximately) | PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Phase 1) | 3 years | The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. Here, Number Analyzed signifies participants analyzed for this outcome measure. | Months | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1) | Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups. | PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 outcomesResults by group3,102
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 Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 10 mg QD (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 25 mg QD (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 50 mg QD (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 75 mg QD (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 100 mg QD (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 150 mg QD (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 200 mg QD (Phase 1) | With DLT | 1 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 35 mg BID (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 75 mg BID (Phase 1) | With DLT | 0 | Participants | |
| Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1 | 100 mg BID (Phase 1) | With DLT | 0 | Participants |
1 to 10 of 3,102Source ClinicalTrials.gov
See all 3,102 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 10 mg QD (Phase 1) | 3 | |
| Overall Study | STARTED | 25 mg QD (Phase 1) | 3 | |
| Overall Study | STARTED | 50 mg QD (Phase 1) | 3 | |
| Overall Study | STARTED | 75 mg QD (Phase 1) | 12 | |
| Overall Study | STARTED | 100 mg QD (Phase 1) | 17 | |
| Overall Study | STARTED | 150 mg QD (Phase 1) | 3 | |
| Overall Study | STARTED | 200 mg QD (Phase 1) | 3 | |
| Overall Study | STARTED | 35 mg BID (Phase 1) | 3 | |
| Overall Study | STARTED | 75 mg BID (Phase 1) | 3 | |
| Overall Study | STARTED | 100 mg BID (Phase 1) | 4 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events9,792
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 | 10 mg QD (Phase 1) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 25 mg QD (Phase 1) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 50 mg QD (Phase 1) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 75 mg QD (Phase 1) | 3 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | 100 mg QD (Phase 1) | 7 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | 150 mg QD (Phase 1) | 3 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 200 mg QD (Phase 1) | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 35 mg BID (Phase 1) | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 75 mg BID (Phase 1) | 2 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | 100 mg BID (Phase 1) | 2 | 4 |
1 to 10 of 9,792Source ClinicalTrials.gov
See all 9,792 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 10 mg QD (Phase 1) | 3 | 3 |
| Total, all-cause mortality | 25 mg QD (Phase 1) | 2 | 3 |
| Total, all-cause mortality | 50 mg QD (Phase 1) | 3 | 3 |
| Total, all-cause mortality | 75 mg QD (Phase 1) | 6 | 12 |
| Total, all-cause mortality | 100 mg QD (Phase 1) | 9 | 17 |
| Total, all-cause mortality | 150 mg QD (Phase 1) | 3 | 3 |
| Total, all-cause mortality | 200 mg QD (Phase 1) | 2 | 3 |
| Total, all-cause mortality | 35 mg BID (Phase 1) | 3 | 3 |
| Total, all-cause mortality | 75 mg BID (Phase 1) | 2 | 3 |
| Total, all-cause mortality | 100 mg BID (Phase 1) | 2 | 4 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers14
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.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Choice Reaction Time | Secondary outcome | ConductCognition |
| Simple Reaction Time | Secondary outcome | ConductCognition |
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/NCT01970865
GET https://conductscience.org/api/trials/v1/NCT01970865/registered?page=2