Trial · NCT00560235
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
NCT00560235, Phase 1, Phase 2, Completed, Pfizer; results first posted 2014-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors. Trials, record NCT00560235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00560235
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
- NCT number
- NCT00560235
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 138 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ewing's Sarcoma Family of Tumors
- Interventions
- CP-751,871
- First posted
- 2007-11-19
- Last updated
- 2015-10-28
- Results first posted
- 2014-02-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Baseline and every cycle (4 weeks), for up to 6 cycles | 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. |
| Secondary | Progression-Free Survival (PFS) | Baseline and every cycle (4 weeks), until progression or death | 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). |
| Secondary | Overall Survival (OS) | Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment | Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 | |
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) | Cycle 6: predose on Day 1 | Cmin is the concentration at the end of treatment cycle (next cycle predose). |
| Secondary | Plasma Concentration at End of Infusion (Cendinf) | Cycle 1 Day 2 and Cycle 5 Day 1 | |
| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Cycle 5: 1 hour post-infusion on Day 1 | The dosing interval was 1 cycle (4 weeks) in this study. |
| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 | AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration. |
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) Titer | Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Baseline and every cycle (4 weeks), for up to 6 cycles | 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. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Baseline and every cycle (4 weeks), until progression or death | All enrolled participants with ESFT and who started treatment with figitumumab. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment | All enrolled participants with ESFT and who started treatment with figitumumab. | months | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) | Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 | 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. | milligrams per liter (mg/L) | GEOMETRIC_MEAN |
| SECONDARY | Minimum Observed Plasma Trough Concentration (Cmin) | Cycle 6: predose on Day 1 | 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. | mg/L | GEOMETRIC_MEAN |
| SECONDARY | Plasma Concentration at End of Infusion (Cendinf) | Cycle 1 Day 2 and Cycle 5 Day 1 | 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. | mg/L | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Cycle 5: 1 hour post-infusion on Day 1 | 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. | milligram*hour per liter (mg*hr/L) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1 | 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. | mg*hr/L | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Positive Anti-Drug Antibody (ADA) Titer | Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose) | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Figitumumab 30 mg/kg (Phase 2) | 14.2 | 95% Confidence Interval 8.1 to 22.3 | percentage of participants | |
| Progression-Free Survival (PFS) | Figitumumab 30 mg/kg (Phase 2) | 1.9 | 95% Confidence Interval 1.8 to 2.1 | months | |
| Overall Survival (OS) | Figitumumab 30 mg/kg (Phase 2) | 8.9 | 95% Confidence Interval 7.2 to 10.8 | months | |
| Maximum Observed Plasma Concentration (Cmax) | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | Cycle 1 (n=4, 6, 21) | 513.2 | Geometric Coefficient of Variation 42 | milligrams per liter (mg/L) |
| Maximum Observed Plasma Concentration (Cmax) | Figitumumab 30 mg/kg Dose Escalation (Phase 1) | Cycle 1 (n=4, 6, 21) | 1075 | Geometric Coefficient of Variation 21 | milligrams per liter (mg/L) |
| Maximum Observed Plasma Concentration (Cmax) | Figitumumab 30 mg/kg Dose Extension (Phase 1B) | Cycle 1 (n=4, 6, 21) | 975.6 | Geometric Coefficient of Variation 26 | milligrams per liter (mg/L) |
| Maximum Observed Plasma Concentration (Cmax) | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | Cycle 5 (n=2, 2, 8) | 729.0 | Geometric Coefficient of Variation 47 | milligrams per liter (mg/L) |
| Maximum Observed Plasma Concentration (Cmax) | Figitumumab 30 mg/kg Dose Escalation (Phase 1) | Cycle 5 (n=2, 2, 8) | 1133 | Geometric Coefficient of Variation 9 | milligrams per liter (mg/L) |
| Maximum Observed Plasma Concentration (Cmax) | Figitumumab 30 mg/kg Dose Extension (Phase 1B) | Cycle 5 (n=2, 2, 8) | 1043 | Geometric Coefficient of Variation 47 | milligrams per liter (mg/L) |
| Minimum Observed Plasma Trough Concentration (Cmin) | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | 389.0 | mg/L |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Figitumumab Dose Escalation (Phase 1) | 10 | |
| Phase 1 | STARTED | Figitumumab Dose Extension (Phase 1B) | 0 | |
| Phase 1 | STARTED | Figitumumab 30 mg/kg (Phase 2) | 0 | |
| Phase 1 | COMPLETED | Figitumumab Dose Escalation (Phase 1) | 2 | |
| Phase 1 | COMPLETED | Figitumumab Dose Extension (Phase 1B) | 0 | |
| Phase 1 | COMPLETED | Figitumumab 30 mg/kg (Phase 2) | 0 | |
| Phase 1 | NOT COMPLETED | Figitumumab Dose Escalation (Phase 1) | 8 | |
| Phase 1 | NOT COMPLETED | Figitumumab Dose Extension (Phase 1B) | 0 | |
| Phase 1 | NOT COMPLETED | Figitumumab 30 mg/kg (Phase 2) | 0 | |
| Phase 1B | STARTED | Figitumumab Dose Escalation (Phase 1) | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events3,104
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 | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 30 mg/kg Dose Escalation (Phase 1) | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 30 mg/kg Dose Extension (Phase 1B) | 0 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1) | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B) | 2 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 30mg/kg (Phase 2) | 14 | 107 | |
| other | Anaemia | Blood and lymphatic system disorders | Figitumumab 30 mg/kg + Rapamycin (Phase 2) | 9 | 29 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | 1 | 4 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Figitumumab 30 mg/kg Dose Escalation (Phase 1) | 0 | 6 |
1 to 10 of 3,104Source ClinicalTrials.gov
See all 3,104 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | ||
| Total, all-cause mortality | Figitumumab 30 mg/kg Dose Escalation (Phase 1) | ||
| Total, all-cause mortality | Figitumumab 30 mg/kg Dose Extension (Phase 1B) | ||
| Total, all-cause mortality | Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1) | ||
| Total, all-cause mortality | Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1) | ||
| Total, all-cause mortality | Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B) | ||
| Total, all-cause mortality | Figitumumab 30mg/kg (Phase 2) | ||
| Total, all-cause mortality | Figitumumab 30 mg/kg + Rapamycin (Phase 2) | ||
| Total, other adverse events | Figitumumab 20 mg/kg Dose Escalation (Phase 1) | 3 | 4 |
| Total, other adverse events | Figitumumab 30 mg/kg Dose Escalation (Phase 1) | 6 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22025154 | 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/NCT00560235
GET https://conductscience.org/api/trials/v1/NCT00560235/results?page=2