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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00560235




Registration number
NCT00560235
Ethics application status
Date submitted
15/11/2007
Date registered
19/11/2007
Date last updated
28/10/2015

Titles & IDs
Public title
Study Of CP-751,871 In Patients With Ewing's Sarcoma Family Of Tumors
Scientific title
A Phase 1/Phase 2 Study Of CP-751,871 In Patients With Relapsed And/Or Refractory Ewing's Sarcoma Family Of Tumors
Secondary ID [1] 0 0
A4021020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ewing's Sarcoma Family of Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CP-751,871

Experimental: 1 -


Treatment: Drugs: CP-751,871
Final dose 30 mg/kg IV on Day 1 of each 28 day cycle until either progression or toxicity

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) - 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.
Timepoint [1] 0 0
Baseline and every cycle (4 weeks), for up to 6 cycles
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) - 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).
Timepoint [1] 0 0
Baseline and every cycle (4 weeks), until progression or death
Secondary outcome [2] 0 0
Overall Survival (OS) - Time in months from enrollment to death. For participants who are alive, overall survival was censored at the last contact.
Timepoint [2] 0 0
Baseline and every 2 cycles (8 weeks), until death or up to 6 cycles after date of enrollment
Secondary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [3] 0 0
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Secondary outcome [4] 0 0
Minimum Observed Plasma Trough Concentration (Cmin) - Cmin is the concentration at the end of treatment cycle (next cycle predose).
Timepoint [4] 0 0
Cycle 6: predose on Day 1
Secondary outcome [5] 0 0
Plasma Concentration at End of Infusion (Cendinf)
Timepoint [5] 0 0
Cycle 1 Day 2 and Cycle 5 Day 1
Secondary outcome [6] 0 0
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) - The dosing interval was 1 cycle (4 weeks) in this study.
Timepoint [6] 0 0
Cycle 5: 1 hour post-infusion on Day 1
Secondary outcome [7] 0 0
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - AUClast is the area under the plasma concentration time-curve from zero to the last measured concentration.
Timepoint [7] 0 0
Cycle 1 and Cycle 5: 1 hour post-infusion on Day 1
Secondary outcome [8] 0 0
Number of Participants With Positive Anti-Drug Antibody (ADA) Titer - 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.
Timepoint [8] 0 0
Cycle 4 (predose on Day 1), 28 days after last dose (End-of-Treatment), and follow-up (approximately 150 days after last dose)

Eligibility
Key inclusion criteria
- Ewing's family of tumors

- Current disease state for which there is no curative therapy
Minimum age
10 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior anti-IGF-1R therapy

- Concurrent treatment with other anti-cancer agents

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Brisbane
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Rhode Island
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Brazil
State/province [10] 0 0
SP
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Chile
State/province [12] 0 0
Santiago, RM
Country [13] 0 0
France
State/province [13] 0 0
Lille Cedex
Country [14] 0 0
France
State/province [14] 0 0
Lyon
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Freiburg
Country [19] 0 0
Germany
State/province [19] 0 0
Muenchen
Country [20] 0 0
Germany
State/province [20] 0 0
Muenster
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Petach Tikva
Country [23] 0 0
Italy
State/province [23] 0 0
Bologna
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Torino
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Valencia
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Surrey
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Define the efficacy of CP-751,871 in patients with Ewing's sarcoma family of tumors
Trial website
https://clinicaltrials.gov/show/NCT00560235
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications