Trial · NCT01576406
Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients
NCT01576406, Phase 1, Completed, Pfizer; results first posted 2018-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients. Trials, record NCT01576406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01576406
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients
- NCT number
- NCT01576406
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 88 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Advanced Cancer
- Interventions
- crizotinib, crizotinib, crizotinib, crizotinib, crizotinib
- First posted
- 2012-04-12
- Last updated
- 2018-10-25
- Results first posted
- 2018-10-25
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | Area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 1 Day 1 | Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 1 Day 1 | Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | |
| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib: Cycle 1 Day 1 | Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | |
| Secondary | Minimum Observed Plasma Concentration (Cmin) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | |
| Secondary | Plasma Accumulation Ratio (Rac) of Crizotinib | Cycle 1 Day 1 and Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | Rac was defined as the ratio of AUCtau of Cycle 2 Day 1 to AUCtau of Cycle 1 Day 1, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing). |
| Secondary | Apparent Oral Clearance (CL/F) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1. |
| Secondary | Fraction of Unbound Crizotinib in Plasma: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | Fraction of unbound Crizotinib concentration in plasma was defined as the ratio of unbound Crizotinib concentration to the total Crizotinib concentration. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set:Cycle 2 Day 1(C2D1)full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria. | nanogram*hour per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 1 Day 1 | Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 1 Day 1 | Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set. Here, 'N' signifies those participants who were evaluable for this measure. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib: Cycle 1 Day 1 | Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set. Here, 'N' signifies those participants who were evaluable for this measure. | hour | MEDIAN |
| SECONDARY | Minimum Observed Plasma Concentration (Cmin) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data. | ||
| SECONDARY | Plasma Accumulation Ratio (Rac) of Crizotinib | Cycle 1 Day 1 and Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data. | ||
| SECONDARY | Apparent Oral Clearance (CL/F) of Crizotinib: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria. | Liter/hour | GEOMETRIC_MEAN |
| SECONDARY | Fraction of Unbound Crizotinib in Plasma: Cycle 2 Day 1 | Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose | PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or\>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria. | ratio | GEOMETRIC_MEAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group717
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 3552 | Geometric Coefficient of Variation 48 | nanogram*hour per milliliter (ng*hr/mL) | |
| Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 2712 | Geometric Coefficient of Variation 66 | nanogram*hour per milliliter (ng*hr/mL) | |
| Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 3238 | Geometric Coefficient of Variation 73 | nanogram*hour per milliliter (ng*hr/mL) | |
| Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily | 2305 | Geometric Coefficient of Variation 83 | nanogram*hour per milliliter (ng*hr/mL) | |
| Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily | 4057 | Geometric Coefficient of Variation 58 | nanogram*hour per milliliter (ng*hr/mL) | |
| Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 | Severe Hepatic Impairment Crizotinib 250 mg Once Daily | 4596 | Geometric Coefficient of Variation 63 | nanogram*hour per milliliter (ng*hr/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1 | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 375.1 | Geometric Coefficient of Variation 50 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1 | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 283.9 | Geometric Coefficient of Variation 65 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1 | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 342.1 | Geometric Coefficient of Variation 68 | nanogram per milliliter (ng/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1 | Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily | 152.9 | Geometric Coefficient of Variation 58 | nanogram per milliliter (ng/mL) |
1 to 10 of 717Source ClinicalTrials.gov
See all 717 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 11 | |
| Overall Study | STARTED | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 15 | |
| Overall Study | STARTED | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 20 | |
| Overall Study | STARTED | Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily | 10 | |
| Overall Study | STARTED | Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily | 16 | |
| Overall Study | STARTED | Severe Hepatic Impairment Crizotinib 250 mg Once Daily | 16 | |
| Overall Study | COMPLETED | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 5 | |
| Overall Study | COMPLETED | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 7 | |
| Overall Study | COMPLETED | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 4 | |
| Overall Study | COMPLETED | Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,266
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 | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 5 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 6 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily | 5 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Severe Hepatic Impairment Crizotinib 250 mg Once Daily | 3 | 16 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 0 | 11 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 0 | 15 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 0 | 20 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily | 1 | 10 |
1 to 10 of 1,266Source ClinicalTrials.gov
See all 1,266 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 3 | 11 |
| Total, all-cause mortality | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 4 | 15 |
| Total, all-cause mortality | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 8 | 20 |
| Total, all-cause mortality | Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily | 5 | 10 |
| Total, all-cause mortality | Moderate Hepatic Impairment: Crizotinib 250 mg Once Daily | 7 | 16 |
| Total, all-cause mortality | Severe Hepatic Impairment Crizotinib 250 mg Once Daily | 9 | 16 |
| Total, other adverse events | Normal Hepatic Function: Crizotinib 250 mg Twice Daily | 11 | 11 |
| Total, other adverse events | Normal Hepatic Function: Crizotinib 200/250 mg Twice Daily | 15 | 15 |
| Total, other adverse events | Mild Hepatic Impairment: Crizotinib 250 mg Twice Daily | 20 | 20 |
| Total, other adverse events | Moderate Hepatic Impairment Crizotinib 200 mg Twice Daily | 9 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29468455 | 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.
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GET https://conductscience.org/api/trials/v1/NCT01576406
GET https://conductscience.org/api/trials/v1/NCT01576406/registered?page=2