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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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13 December 2021 |
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Main ID: |
EUCTR2008-005182-66-FR |
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Date of registration:
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16/03/2009 |
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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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PHASE II OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES
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Scientific title:
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PHASE II OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES |
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Date of first enrolment:
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08/04/2009 |
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Target sample size:
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58 |
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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:2008-005182-66 |
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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:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
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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Austria
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France
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Hungary
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Latvia
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. The patient must consent in writing to participate in the study by signing and dating an informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to conducting any study-related procedures.
2. The patient met the eligibility criteria for, and was randomized and treated with intravenous study drug in Study A4091003.
3. At least 8 weeks but no more than 16 weeks has elapsed since the intravenous study drug infusion in Study A4091003.
4. Female patients must meet one of the following criteria:
a. Female patients of non-childbearing potential: must be post menopausal, defined as women who are = 45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels at Study A4091003 Screening) or women who are amenorrheic for at least 1 year AND have a serum follicle stimulating hormone (FSH) level greater than 30 IU/L at Study A4091003 Screening; or be surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy;
b. Female patients of child bearing potential: must not be pregnant or lactating and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method) from Baseline visit until 16 weeks after the last dose of study medication. Women of childbearing potential must have a negative erum pregnancy test at Study A4091003 Termination Visit or a negative urine regnancy test at Baseline prior to initial dosing.
Male patients must agree that they and their female spouses/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non childbearing potential.
In the event of indeterminate or anomalous results on pregnancy/FSH testing or issues surrounding contraceptive requirements, study management should be contacted and will make the final decision as to the adequacy/need for contraception.
5. The patient has a Karnofsky Performance Score =40% at Baseline;
6. The patient has an anticipated life expectancy of =6 months at Baseline;
7. The patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patients presenting with any of the following will not enter the study:
1. The patient was withdrawn from Study A4091003 for an adverse event or serious adverse event.
2. Use of any investigational medication within 30 days prior to Baseline or plans to receive an investigational medication other than the study medication during the course of this study.
3. Patients who discontinued Study A4091003 prior to Week 8 because of lack of compliance, protocol violation, not meeting entrance criteria, withdrawal of consent, disease progression or patients who were lost to follow up will be excluded from Study A4091029.
4. Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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PAIN DUE TO BONE METASTASES
MedDRA version: 9.1
Level: LLT
Classification code 10049038
Term: Metastatic bone pain
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Intervention(s)
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Product Name: Tanezumab
Product Code: PF-04383119
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Tanezumab
Current Sponsor code: PF-04383119
Other descriptive name: RN624, RI624
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
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Primary Outcome(s)
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Primary end point(s): Safety Measures:
1. Adverse events;
2. Clinical laboratory tests;
3. Electrocardiogram (ECG);
4. Neurologic exam (Neuropathy Impairment Score [NIS]);
5. Anti-Drug Antibody (ADA) assessments;
6. Physical examinations;
7. Vital signs.
Efficacy Endpoints:
1. Change from Baseline to Weeks 4, 8, 16, 24 and 40 in the Brief Pain Inventory-Short Form (mBPI-sf) pain scores at its ‘worst’, ‘least’, ‘average’ and ‘right now’.
2. Change from Baseline to Weeks 4, 8, 16, 24 and 40 in the mBPI-sf Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits.
Patient Status:
1. Karnofsky Performance Scale.
Pharmacokinetics (PK):
1. Measurement of pre-dosing serum tanezumab concentrations (Population PK) at
Baseline and End of Treatment/Early Termination.
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Main Objective: To evaluate the safety and efficacy of the 10 mg intravenous (IV) dose of tanezumab in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label tanezumab therapy.
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Secondary Objective: There are no secondary objectives in this trial
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Secondary ID(s)
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2008-005182-66-HU
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A4091029
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 08/04/2009
Contact:
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