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Completed

NCT Number: NCT01340040

Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects

The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.

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Key information

Conditions

Cancer Advanced Solid Malignancies Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Matsuyama, Ehime, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEDI-573

Drug

MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.

Primary outcomes

  1. Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination

    Time frame: All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Secondary outcomes

  1. Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies)

    Time frame: For Cohorts 1, 2 and 3:day 1 (pre-dose) of every cycle; 30 days after the last dose; 3 months after the last dose

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  2. Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST)

    Time frame: Tumor assessment by RECIST 1.1 every 2 cycles

    subjects who discontinue the study treatment for reasons other than disease progression or initiation of alternative anticancer therapy will undergo tumor assessment 3 months after the last dose of MEDI-573). The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  3. Pharmacokinetics, - Cmax

    Time frame: For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  4. Pharmacokinetics,- Cmax at steady state (Cmax, ss)

    Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  5. Pharmacokinetics - time to maximum concentration (tmax)

    Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  6. Pharmacokinetics, - terminal elimination rate constant (λz)

    Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  7. Pharmacokinetics - (AUC(0-t))

    Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  8. Pharmacokinetics - total clearance and terminal phase (Vz) of MEDI-573

    Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

  9. Pharmacodynamics: - Insulin-like growth factor (IGF)-I and IGF-II on circulating plasma levels of MEDI-573

    Time frame: For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.

    The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • MedImmune LLC

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2011
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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