Trial · NCT01597258
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
NCT01597258, Completed, Pfizer; results first posted 2019-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan). Trials, record NCT01597258. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01597258
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT01597258
- Status
- Completed
- Enrollment
- 2,029 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Crizotinib (Xalkori)
- First posted
- 2012-05-14
- Last updated
- 2019-09-13
- Results first posted
- 2019-09-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | 52 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. |
| Secondary | Objective Response Rate (ORR) at 52 Weeks | 52 weeks | Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). |
Source ClinicalTrials.gov
Outcomes2
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 Adverse Drug Reactions | 52 weeks | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XALKORI Capsules at least once. | Participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) at 52 Weeks | 52 weeks | The efficacy analysis set (EAS) is comprised in the safety analysis set who had at least one measurable lesion and were evaluated for effectiveness. 1633 participants were included in the EAS. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
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 Adverse Drug Reactions | XALKORI Capsules (Crizotinib) | ADR | 1858 | Participants | |
| Number of Participants With Adverse Drug Reactions | XALKORI Capsules (Crizotinib) | Serious ADR | 518 | Participants | |
| Objective Response Rate (ORR) at 52 Weeks | XALKORI Capsules (Crizotinib) | 66.5 | 95% Confidence Interval 64.2 to 68.8 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | XALKORI Capsules (Crizotinib) | 2,029 | |
| Overall Study | COMPLETED | XALKORI Capsules (Crizotinib) | 2,028 | |
| Overall Study | NOT COMPLETED | XALKORI Capsules (Crizotinib) | 1 |
Source ClinicalTrials.gov
Adverse events759
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 | Dysgeusia | Nervous system disorders | XALKORI Capsules (Crizotinib) | 339 | 2,028 | |
| other | Decreased appetite | Metabolism and nutrition disorders | XALKORI Capsules (Crizotinib) | 210 | 2,028 | |
| other | White blood cell count decreased | Investigations | XALKORI Capsules (Crizotinib) | 109 | 2,028 | |
| other | Blood creatinine increased | Investigations | XALKORI Capsules (Crizotinib) | 190 | 2,028 | |
| other | Neutrophil count decreased | Investigations | XALKORI Capsules (Crizotinib) | 166 | 2,028 | |
| other | Blood alkaline phosphatase increased | Investigations | XALKORI Capsules (Crizotinib) | 115 | 2,028 | |
| other | Aspartate aminotransferase increased | Investigations | XALKORI Capsules (Crizotinib) | 271 | 2,028 | |
| other | Alanine aminotransferase increased | Investigations | XALKORI Capsules (Crizotinib) | 291 | 2,028 | |
| other | Liver disorder | Hepatobiliary disorders | XALKORI Capsules (Crizotinib) | 145 | 2,028 | |
| other | Hepatic function abnormal | Hepatobiliary disorders | XALKORI Capsules (Crizotinib) | 249 | 2,028 |
1 to 10 of 759Source ClinicalTrials.gov
See all 759 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XALKORI Capsules (Crizotinib) | 436 | 2,028 |
| Total, other adverse events | XALKORI Capsules (Crizotinib) | 1,783 | 2,028 |
| Total, serious adverse events | XALKORI Capsules (Crizotinib) | 777 | 2,028 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31008509 | DERIVED |
Source PubMed
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/NCT01597258
GET https://conductscience.org/api/trials/v1/NCT01597258/events?page=2