Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Sarcoma, Ewing

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

CP-751,871

Pfizer CT.gov Call Center

Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors

Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors

Percentage of participants with objective response based on assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease and no new lesions. PR was defined as ≥30% decrease under baseline of the sum of diameters of all target lesions.

PFS was the time in months from start date to date of first documentation of progression, death due to any cause or symptomatic deterioration (global deterioration of health status requiring discontinuation of treatment).

Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.

Cmin is the concentration at the end of treatment cycle (next cycle predose).

The dosing interval was 1 cycle (4 weeks) in this study.

AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.

Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer \<6.64 corresponded to negative ADA category value.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).

Figitumumab 20 mg/kg Dose Escalation (Phase 1)

Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).

Figitumumab 30 mg/kg Dose Escalation (Phase 1)

Figitumumab 30 mg/kg Dose Extension (Phase 1B)

Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.

Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)

Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.

Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)

Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)

Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.

Figitumumab 30mg/kg (Phase 2)

Figitumumab 30 mg/kg + Rapamycin (Phase 2)

Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Figitumumab Dose Escalation (Phase 1)

Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Figitumumab Dose Extension (Phase 1B)

Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.

Figitumumab 30 mg/kg (Phase 2)

Total

10 to <13 years

13 to <=18 years

18 to <30 years

30 to <41 years

>=41 years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

All enrolled participants with Ewing's sarcoma family of tumors (ESFT) and who started treatment with figitumumab; number of evaluable participants at data cut-off.

Objective Response Rate (ORR)

All enrolled participants with ESFT and who started treatment with figitumumab.

Progression-Free Survival (PFS)

Overall Survival (OS)

Cycle 1 (n=4, 6, 21)

Cycle 5 (n=2, 2, 8)

The pharmacokinetic (PK) analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.

Maximum Observed Plasma Concentration (Cmax)

The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; number of participants evaluated for measure.

Minimum Observed Plasma Trough Concentration (Cmin)

The PK analysis set included all enrolled participants who started treatment and who had sufficient samples to provide interpretable results; n=number of participants evaluable for this measure at specified time points for each arm group, respectively.

Plasma Concentration at End of Infusion (Cendinf)

Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).

Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).

Figitumumab 30 mg Dose Escalation (Phase 1)

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Cycle 1 (n=3, 5, 16)

Cycle 5 (n=1, 1, 6)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

All enrolled participants with ESFT and who started treatment with figitumumab. None of the serum samples were positive for ADAs following repeated administration of figitumumab, as indicated by an endpoint titer of \<6.64.

Spots Global Cancer Trial Database for Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors

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