Trial · NCT01999972
A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors
NCT01999972, Phase 1, Completed, Pfizer; results first posted 2019-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors. Trials, record NCT01999972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01999972
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors
- NCT number
- NCT01999972
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Advanced Solid Tumors
- Interventions
- axitinib, crizotinib, axitinib, crizotinib, axitinib, crizotinib
- First posted
- 2013-12-03
- Last updated
- 2020-09-24
- Other registries' IDs
- eudract:2015-001724-31
- Results first posted
- 2019-06-21
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 days) | Toxicity as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. DLT defined as any following events attributable to any (axitinib or crizotinib) or both agents in combination: hematologic (Grade 4 neutropenia, absolute neutrophil count\<1000/mm\^3 with single temperature of \>38.3 degrees celsius or sustained temperature of 38 degrees celsius for \>1 hour; \>=Grade 3 neutropenic infection; \>=Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia), non-hematologic (\>=Grade 3 toxicities \[except asymptomatic hypophosphatemia, hyperuricemia without signs, symptoms of gout, and tumor lysis syndrome\], nausea, vomiting or diarrhea persisted at Grade 3 or 4 despite maximal medical therapy; Grade 3 hypertension if persistent despite anti-hypertensives); In asymptomatic participant, Grade 3 QTc prolongation (QTc\>=501 msec) if persisted after correcting reversible causes, and failure to deliver \>=75 percent (%) of dose of each study drug. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | An AE was any untoward medical occurrence in a participant who received study drugs (crizotinib and axitinib) without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Secondary | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Treatment-related AE was any untoward medical occurrence attributed to study drugs (crizotinib and axitinib) in a participant who received study drugs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03 | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included haemoglobin (anemia, haemoglobin increased), lymphocytes (lymphopenia, lymphocyte count increased), neutrophils, platelets and white blood cells. Number of participants with hematological abnormalities by grades (as per NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters/abnormalities included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia and gamma glutamyl transferase Number of participants with biochemistry test abnormalities by grades (NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | |
| Secondary | Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | |
| Secondary | Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | |
| Secondary | Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) | ECOG-PS: used to assess how disease affected the daily living abilities of participant. It ranges on the scale from: 0-5 (0=fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity but ambulatory/able to carry out light/sedentary work;2=ambulatory \[for more than (\>)50%of waking hours\], capable of all self-care but unable to carry out any work activities;3=capable of limited self-care, confined to bed or chair \[for \>50% of waking hours\];4=completely disabled, not capable of any self-care, totally confined to bed or chair;5= dead, higher score=more functional impairment) and changes to worst status scores were presented. Baseline value=value collected prior to first dose of study drug on Cycle 1 Day 1. Worst post-baseline value=worst value between first dose of any study drug and end of treatment (EOT) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for ECOG-PS. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Cycle 1 (28 days) | Per protocol analysis set:all enrolled participants who received at least 1 dose of study drug, experienced either DLT during first cycle,or completed first cycle observation period.Participants who lost to follow up before receiving at least 75% of planned first cycle dose due to reasons other than treatment-related AEs were not evaluable for DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03 | First dose of study drug until 28 days after last dose (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities | Baseline up to end of treatment (up to 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the number analyzed field signifies that none of the participant were evaluable at specified time point. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the number analyzed field signifies that none of the participant were evaluable at specified time point. | beats per minute (bpm) | MEAN |
| SECONDARY | Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment | Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 35 cycles in Part 1 and 35 cycles in Part 2, each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0' in the number analyzed field signifies that none of the participant were evaluable at specified time point. | kilograms | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value | Baseline, End of Treatment (up to Cycle 35 [for Part 1] and up to Cycle 35 [for Part 2], each cycle 28 days) | Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group1,108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 0 | Participants | ||
| Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 0 | Participants | ||
| Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 0 | Participants | ||
| Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | AEs | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | AEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | AEs | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | AEs | 10 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | AEs | 21 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | AEs | 7 | Participants |
1 to 10 of 1,108Source ClinicalTrials.gov
See all 1,108 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Part | STARTED | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 5 | |
| Dose Escalation Part | STARTED | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 3 | |
| Dose Escalation Part | STARTED | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 5 | |
| Dose Escalation Part | STARTED | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 11 | |
| Dose Escalation Part | STARTED | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | 0 | |
| Dose Escalation Part | STARTED | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | 0 | |
| Dose Escalation Part | Treated | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 5 | |
| Dose Escalation Part | Treated | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 3 | |
| Dose Escalation Part | Treated | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 4 | |
| Dose Escalation Part | Treated | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 10 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events888
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 | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 1 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | 0 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | 2 | 7 | |
| other | Bradycardia | Cardiac disorders | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 0 | 5 | |
| other | Bradycardia | Cardiac disorders | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 0 | 3 | |
| other | Bradycardia | Cardiac disorders | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 0 | 4 | |
| other | Bradycardia | Cardiac disorders | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 1 | 10 |
1 to 10 of 888Source ClinicalTrials.gov
See all 888 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 0 | 5 |
| Total, all-cause mortality | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 1 | 3 |
| Total, all-cause mortality | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 0 | 4 |
| Total, all-cause mortality | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 0 | 10 |
| Total, all-cause mortality | Dose Expansion Part: Cohort 1 Crizotinib 250 mg+Axitinib 5 mg | 2 | 21 |
| Total, all-cause mortality | Dose Expansion Part: Cohort 2 Crizotinib 250 mg+Axitinib 5 mg | 1 | 7 |
| Total, other adverse events | Dose Escalation Part: Crizotinib 200mg+Axitinib 3mg | 5 | 5 |
| Total, other adverse events | Dose Escalation Part: Crizotinib 250mg+Axitinib 3mg | 3 | 3 |
| Total, other adverse events | Dose Escalation Part: Crizotinib 200 mg+Axitinib 5 mg | 3 | 4 |
| Total, other adverse events | Dose Escalation Part: Crizotinib 250 mg+Axitinib 5 mg | 10 | 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 |
|---|---|
| 31171735 | 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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