A Phase 1 interventional study of CP-751,871 and Sunitinib in Advanced Cancer and Advanced Solid Tumors, sponsored by Pfizer. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-09.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.
The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.
Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Escalating cohorts of CP-751,871 + Sunitinib
Drug: CP-751,871 · Drug: Sunitinib
CP-751,871 IV, every 3 weeks
Sunitinib - daily dosing
Number of Participants With Dose-Limiting Toxicities (DLT)
Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (\>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Time frame: Baseline up to the end of Cycle 1 (each cycle=3 weeks)
Percentage of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for Adverse Events Grade Version 3.0
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).
Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Percentage of Participants With Hematologic Laboratory Test Abnormality
Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Percentage of Participants With Blood Chemistry Laboratory Test Abnormality
Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
Time frame: Baseline, Day 1 of every cycle, Days 8 and 15 of Cycle 1, up to end of treatment (28 days post last dose)
Plasma Concentration at the End of Infusion (Cendinf) of Figitumumab
Time frame: 0.5 hour predose and 1 hour post-infusion on Day 1 of Cycles 1 and 4
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
Time frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, 15, and 22 of Cycles 1 and 4
Area Under the Curve From Time Zero to Day 22 [AUC504] of Figitumumab
AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
Time frame: 0.5 hour predose and 504 hours (Day 22) post-infusion of Cycles 1 and 4
Plasma Decay Half-Life (t1/2) of Figitumumab
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0.5 hour predose and 1 hour post-infusion on Days 1, 2, 4, 8, and 15 of Cycles 1 and 4
Maximum Observed Plasma Concentration (Cmax) of Sunitinib
Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib
Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib
AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).
Time frame: 0.5 hour predose and 2, 4, 6, 8, 12, and 24 hours postdose on Day 15 of Cycle 1
Trough Plasma Concentration (Ctrough) of Sunitinib
Time frame: 0.5 hour predose on Day 1 of Cycle 2
Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib
Time frame: 24 hours postdose on Day 15 of Cycle 1
Number of Participants With Anti-Drug Antibodies (ADA)
Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.
Time frame: 0.5 hour pre-infusion on Day 1 in Cycles 1 and 2, at end of treatment, and during the last scheduled follow-up visit (5 months from the last dose of study drug)
Number of Participants With Objective Response (OR)
Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Time frame: Baseline, Day 15 of every 2 cycles until disease progression up to follow-up (approximately 28 days following the last dose of study drug)
| Milestone | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Started | 20 | 7 | 12 | 6 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 20 | 7 | 12 | 6 |
| Withdrew: Death | 5 | 1 | 3 | 5 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 3 | 0 |
| Withdrew: Unspecified reasons | 11 | 5 | 5 | 1 |
Number of participants with treatment-related Grade 3/4 toxicities that occurred during the defined time frame or that resulted in greater than or equal to (\>=) 7 days delay in administration of Cycle 2. Toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
| participants | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Number of Participants With Dose-Limiting Toxicities (DLT) | 0 | 1 | 3 | 1 |
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Severity grades were 0 (no change from normal or reference range), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), and 5 (death).
| percentage of participants | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Any AEs, Grade 1 | 0.0 | 0.0 | 16.7 | 0.0 |
| Any AEs, Grade 2 | 20.0 | 28.6 | 8.3 | 0.0 |
| Any AEs, Grade 3 | 40.0 | 42.9 | 50.0 | 16.7 |
| Any AEs, Grade 4 | 10.0 | 14.3 | 8.3 | 0.0 |
| Any AEs, Grade 5 | 30.0 | 14.3 | 16.7 | 83.3 |
| Any AEs, Total | 100.0 | 100.0 | 100.0 | 100.0 |
Percentage of participants with hematologic laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
| percentage of participants | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Hemoglobin | 70.0 | 85.7 | 75.0 | 83.3 |
| Lymphocytes (Absolute) | 85.0 | 85.7 | 91.7 | 33.3 |
| Neutrophils (Absolute) | 40.0 | 71.4 | 16.7 | 16.7 |
| Platelets | 80.0 | 100.0 | 58.3 | 50.0 |
| White Blood Cells | 65.0 | 71.4 | 41.7 | 33.3 |
Percentage of participants with blood chemistry laboratory abnormalities of CTC severity grades 1, 2, 3, or 4 (grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=life-threatening or disabling).
| percentage of participants | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Alanine Aminotransferase (n=19, 7, 12 ,6) | 57.9 | 57.1 | 33.3 | 0.0 |
| Alkaline Phosphatase (n=19, 7, 12, 6) | 52.6 | 57.1 | 58.3 | 66.7 |
| Aspartate Aminotransferase (n=19, 7, 12, 6) | 63.2 | 71.4 | 66.7 | 16.7 |
| Bicarbonate (n=19, 7, 12, 6) | 26.3 | 71.4 | 16.7 | 33.3 |
| Total Bilirubin (n=19, 7, 12, 6) | 21.1 | 71.4 | 25.0 | 0.0 |
| Creatinine (n=19, 7, 12, 6) | 26.3 | 57.1 | 41.7 | 50.0 |
| Hypercalcemia (n=19, 7, 12, 6) | 0.0 | 14.3 | 16.7 | 0.0 |
| Hyperglycemia (n=19, 7, 12, 6) | 78.9 | 100.0 | 75.0 | 83.3 |
| Hyperkalemia (n=19, 7, 12, 6) | 5.3 | 14.3 | 16.7 | 33.3 |
| Hypermagnesemia (n=17, 7, 12, 6) | 5.9 | 0.0 | 8.3 | 16.7 |
| Hypernatremia (n=19, 7, 12, 6) | 5.3 | 0.0 | 0.0 | 16.7 |
| Hypoalbuminemia (n=19, 7, 12, 6) | 42.1 | 42.9 | 33.3 | 83.3 |
| Hypocalcemia (n=19, 7, 12, 6) | 47.4 | 57.1 | 33.3 | 50.0 |
| Hypokalemia (n=19, 7, 12, 6) | 15.8 | 28.6 | 8.3 | 16.7 |
| Hypomagnesemia (n=17, 7, 12, 6) | 23.5 | 71.4 | 25.0 | 33.3 |
| Hyponatremia (n=19, 7, 12, 6) | 57.9 | 42.9 | 50.0 | 66.7 |
| Hypophosphatemia (n=17, 7, 11, 6) | 23.5 | 57.1 | 18.2 | 0.0 |
| milligram/liter (mg/L) | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Cycle 1 (n=11) | 203.1 ± 27 |
| Cycle 4 (n=4) | 256.3 ± 28 |
AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
| milligram*hour/milliliter (mg*hr/mL) | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Cycle 1 (n=8) | 27320 ± 20 |
| Cycle 4 (n=4) | 37850 ± 4 |
AUC504 is the area under the plasma concentration versus time curve from time zero (predose) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.
| mg*hr/mL | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Cycle 1 (n=8) | 33800 ± 18 |
| Cycle 4 (n=4) | 46960 ± 6 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| hours | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Cycle 1 (n=8) | 245.0 ± 55.0 |
| Cycle 4 (n=4) | 268.0 ± 75.6 |
| nanogram/milliliter (ng/mL) | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Sunitinib | 39.19 ± 38 |
| hours | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sunitinib | 4.07 (2.00 to 24.0) |
AUC24 is the area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0 to 24).
| nanogram*hour/milliliter (ng*hr/mL) | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of Sunitinib | 786.8 ± 42 |
| ng/mL | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Trough Plasma Concentration (Ctrough) of Sunitinib | 28.27 ± 47 |
| ng/mL | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD (Dose Expansion) |
|---|---|
| Plasma Concentration at 24 Hours Postdose (C24) of Sunitinib | 28.87 ± 53 |
Assays for ADA assessment specific for figitumumab would have provided information regarding an immune response to the compound.
No measurements were reported for this outcome.
Objective response (OR) was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. CR was the complete disappearance of all target and non-target disease, no new lesions, or the normalization of markers (if markers were being followed). PR was greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-target disease, no new lesions, or no reappearance of lesions after a CR. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
| participants | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Complete Response (CR) | 0 | 0 | 0 | 0 |
| Partial Response (PR) | 1 | 0 | 1 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | — | 10/20 (50%) | 20/20 (100%) |
| Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | — | 3/7 (42.9%) | 7/7 (100%) |
| Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | — | 6/12 (50%) | 12/12 (100%) |
| Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 | — | 5/6 (83.3%) | 6/6 (100%) |
| Event | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| Disease progressionGeneral disorders | 5/20 | 0/7 | 2/12 | 3/6 |
| Abdominal painGastrointestinal disorders | 1/20 | 0/7 | 0/12 | 1/6 |
| Small intestinal perforationGastrointestinal disorders | 0/20 | 0/7 | 0/12 | 1/6 |
| HyperglycaemiaMetabolism and nutrition disorders | 0/20 | 0/7 | 0/12 | 1/6 |
| Renal failureRenal and urinary disorders | 0/20 | 0/7 | 0/12 | 1/6 |
| Ureteric obstructionRenal and urinary disorders | 0/20 | 0/7 | 0/12 | 1/6 |
| AspirationRespiratory, thoracic and mediastinal disorders | 0/20 | 0/7 | 0/12 | 1/6 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/20 | 0/7 | 0/12 | 1/6 |
| Deep vein thrombosisVascular disorders | 0/20 | 1/7 | 1/12 | 1/6 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/20 | 1/7 | 1/12 | 0/6 |
| Event | Figitumumab 10 mg/kg + Sunitinib 25 mg CDD | Figitumumab 10 mg/kg + Sunitinib 37.5 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg CDD | Figitumumab 20 mg/kg + Sunitinib 25 mg Schedule 2/1 |
|---|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 7/20 | 6/7 | 2/12 | 0/6 |
| FatigueGeneral disorders | 14/20 | 6/7 | 9/12 | 5/6 |
| AnaemiaBlood and lymphatic system disorders | 7/20 | 5/7 | 1/12 | 0/6 |
| DiarrhoeaGastrointestinal disorders | 12/20 | 5/7 | 7/12 | 2/6 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 3/20 | 5/7 | 3/12 | 0/6 |
| NauseaGastrointestinal disorders | 5/20 | 4/7 | 4/12 | 4/6 |
| Weight decreasedInvestigations | 2/20 | 2/7 | 2/12 | 4/6 |
| DysgeusiaNervous system disorders | 12/20 | 4/7 | 3/12 | 0/6 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/20 | 4/7 | 1/12 | 0/6 |
| Mucosal inflammationGeneral disorders | 4/20 | 3/7 | 2/12 | 0/6 |
Full Analysis Set: All enrolled participants who received at least 1 dose of figitumumab plus sunitinib.
| Age, Customized(participants) | Figitumumab + Sunitinib (All Combined) |
|---|---|
| 18 to 44 years | 11 |
| 45 to 64 years | 22 |
| Greater than or equal to (>=) 65 years | 12 |
| Sex: Female, Male(Participants) | Figitumumab + Sunitinib (All Combined) |
|---|---|
| Female | 25 |
| Male | 20 |
The record gives a start of Sep 2008, a primary completion of Aug 2011 and a completion of Apr 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2014, 2 years 10 months after primary completion.
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This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Figitumumab · Sunitinib