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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2007-004486-17-GB |
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Date of registration:
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15/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A PHASE 1/PHASE 2 STUDY OF CP-751,871 IN PATIENTS WITH RELAPSED AND/OR REFRACTORY EWING’S SARCOMA FAMILY OF TUMORS
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Scientific title:
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A PHASE 1/PHASE 2 STUDY OF CP-751,871 IN PATIENTS WITH RELAPSED AND/OR REFRACTORY EWING’S SARCOMA FAMILY OF TUMORS |
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Date of first enrolment:
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26/08/2008 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004486-17 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Germany
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Phase 1: Male and female patients 10-18 years old. Phase 2: Male and female patients at least 10 years old. This is multiple center and multinational study. Individual investigators may elect to restrict enrollment to an older age cohort, eg, 13 years old or older, according to local institutional practices;
2. Phase 1 Dose Escalation: Histologically or cytologically confirmed (no new biopsy
required) diagnosis of sarcomas including osteosarcoma, rhabdomyosarcoma,
non-rhabdomyosarcoma soft tissue sarcoma, desmoplastic small round cell tumor
(DSRCT) or any ESFT, ie, Ewing’s sarcoma, extra-osseous Ewing’s sarcoma,
Askin’s and Primitive Neuroectodermal Tumors (PNET);
Phase 1 RP2D Extension: Sarcoma patients as defined in the Phase 1 Dose Escalation inclusion criterion. Upon opening of the Phase 2 portion of the study, Ewing’s sarcoma patients with at least one measurable lesion as defined by RECIST will be enrolled in the Phase 2 cohort. Ewing’s sarcoma patients with non RECIST
measurable disease may be enrolled in the Phase 1 RP2D Extension cohort;
4. Phase 2: Histologically confirmed (no new biopsy required) ESFT of the bone or soft tissue (Ewing’s sarcoma, extra-osseous Ewing’s sarcoma, PNET and Askin’s
tumors);
5. Current disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life;
6. Phase 2 only: Progressive disease with at least one measurable lesion as defined by RECIST;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 or a Lansky score >/=80%;
8. Life expectancy of at least 3 months;
9. Adequate recovery from major surgery prior to study treatment. Wound healing must be complete;
10. Adequate bone marrow function documented within 2 weeks prior to treatment,
defined as:
Absolute Neutrophil Count (ANC) >/=1000/µL;
Platelets >/=75,000/µL (Previous transfusion is allowed);
Hemoglobin >/=8 g/dL (Previous transfusion is allowed).
11. Adequate renal, hepatic and cardiac functions documented within 2 weeks prior to study treatment, defined as:
Total bilirubin Gilbert’s syndrome patients);
Serum alanine aminotransferase (ALT) Aspartate aminotransferase (AST) Serum creatinine Cardiac Shortening Fraction >/=28% or Ejection Fraction =50%.
12. Phase 1: Prior radiotherapy (at least 1 week prior to enrollment). Phase 2: Prior
radiotherapy (at least 1 week prior to enrollment) is allowed provided is not at the
only site of measurable disease. A measurable lesion that has been irradiated will beconsidered measurable only when it has increased in size. Patients must have
recovered from all acute radiation toxicities (< Grade 1 or deemed irreversible) before
enrollment (Prior radiotherapy is not required for inclusion);
13. Fully recovered (< Grade 1 or deemed irreversible) from the acute effects of prior
Exclusion criteria:
Patients presenting with any of the following will not be included in the trial, unless there is a
compelling reason which is to be agreed by the investigator and sponsor prior to
randomization:
1. Concurrent treatment with any anti tumor agents;
2. Phase 2 only: Prior anti-IGF-IR therapy;
Patients with symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have
recovered from the acute effects of radiation therapy or surgery prior to the start of
study medication, have discontinued corticosteroid treatment for these metastases for at least 1 week, and are neurologically stable;
4. Breastfeeding females;
5. Significant active cardiac disease including: uncontrolled high blood pressure
(no greater than 2 SD above the mean for age for SBP and DBP), unstable angina,
congestive heart failure, valvular disease, endocarditis, myocardial infarction within
the previous 6 months, or serious cardiac arrhythmias;
6. Subjects who are receiving chronic high dose immunosuppressive steroid therapy
within 2 weeks prior to enrollment (eg, for adults: >/=100 mg prednisone per day or
>/=40 mg dexamethasone per day; for children: >/=20 mg prednisone or =2 mg
dexamethasone per day);
7. Active infection;
8. HbA1c>8%;
9. History of malignancies not included in this protocol, within 5 years prior to
enrollment, at sites other than curatively treated in situ carcinoma of the cervix, or the uterus, or basal or squamous cell carcinoma of the skin;
10. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the Investigator, would make the subject
inappropriate for entry into this study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ewing's sarcoma family tumours
MedDRA version: 13.1
Level: PT
Classification code 10015562
Term: Ewing's sarcoma metastatic
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Code: CP-751,871
Pharmaceutical Form:
Current Sponsor code: CP-751,871
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Main Objective: Primary Objective:
To define the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of CP-751,871 in adolescents (10-18 years).
Phase 2
To define the efficacy of CP-751,871, in terms of objective response rate, in patients with relapsed/refractory Ewing’s sarcoma family of tumors.
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Primary end point(s): Phase 1
Primary Endpoint:
Adverse events and laboratory abnormalities
(CTCAE v3.0 grade, timing, seriousness and relatedness).
Secondary Endpoints:
PK parameters of CP-751,871;
ADA
Phase 2
Primary Endpoint:
Objective responses (RECIST).
Secondary Endpoints:
Progression-free survival;
Survival;
Adverse events and laboratory abnormalities
(CTCAE v3.0 grade, timing, seriousness and relatedness);
Peak and trough concentrations of CP-751,871;
ADA.
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Secondary Objective: Secondary Objectives:
To characterize the safety and tolerability profile of CP-751,871 in adolescents;
To evaluate the PK of CP-751,871 in adolescents;
To test for the occurrence of Anti-Drug Antibody (ADA) response to CP-751,871 in
adolescents.
Phase 2
To obtain preliminary Progression Free Survival (PFS) information in ESFT patients
treated with CP-751,871;
To obtain preliminary Overall Survival (OS) information in ESFT patients treated
with CP-751,871;
To assess CP-751,871 safety in this patient population;
To collect PK data of CP-751,871 for future population PK meta-analysis;
To monitor for the occurrence of ADA response to CP-751,871.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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