A Phase 1, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Japanese Subjects With Advanced Solid Tumours Refractory to Standard Therapy or for Which No Standard Therapy Exists
20 Years
N/A
Both
Cancer, Advanced Solid Malignancies
Trial Information
A Phase 1, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Japanese Subjects With Advanced Solid Tumours Refractory to Standard Therapy or for Which No Standard Therapy Exists
Inclusion Criteria:
- Japanese men or women at least 20 years of age
- Histological or cytological confirmation of a solid, malignant tumour excluding
lymphoma that is refractory to standard therapies or for which no standard therapies
exist
- WHO performance status 0-2 with no deterioration over the previous 2 weeks
Exclusion Criteria:
- Previous therapy with medication against IGF (ie, monoclonal antibodies with IGF-1R
or IGF-targeting tyrosine kinase inhibitors)
- Inadequate bone marrow reserve or organ function
- Poorly controlled diabetes mellitus as defined by the investigator's assessment
and/or glycosylated hemoglobin (HbA1c) reading > 6.5% within 28 days prior to the
first dose of MEDI-573
- History of allergy or reaction to any component of the MEDI-573 formulation or drugs
with a similar chemical structure or class to MEDI-573
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination
Outcome Description:
The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Outcome Time Frame:
All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment.
Safety Issue:
Yes
Principal Investigator
Edward Bradley, MD
Investigator Role:
Study Director
Investigator Affiliation:
MedImmune LLC
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D5621C00006
NCT ID:
NCT01340040
Start Date:
July 2011
Completion Date:
May 2012
Related Keywords:
- Cancer
- Advanced Solid Malignancies
- Phase I
- cancer
- solid tumours
- advanced solid malignancies
- dose escalation
- Insulin like growth factor
- Japanese
- Neoplasms
Name | Location |
|---|
