NCT01340040

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

April 11, 2011

Last Update Submit

December 10, 2014

Conditions

CancerAdvanced Solid Malignancies

Keywords

Phase Icancersolid tumoursadvanced solid malignanciesdose escalationInsulin like growth factorJapanese

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (9)

  • Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies)

    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

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

    Tumor assessment by RECIST 1.1 every 2 cycles

  • Pharmacokinetics, - Cmax

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

  • Pharmacokinetics,- Cmax at steady state (Cmax, ss)

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

  • Pharmacokinetics - time to maximum concentration (tmax)

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

  • +4 more secondary outcomes

Study Arms (1)

MEDI-573

EXPERIMENTAL

MEDI-573

Drug: MEDI-573

Interventions

MEDI-573DRUG

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.

MEDI-573

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Matsuyama, Ehime, Japan

Location

Related Publications (1)

  • Iguchi H, Nishina T, Nogami N, Kozuki T, Yamagiwa Y, Yagawa K. Phase I dose-escalation study evaluating safety, tolerability and pharmacokinetics of MEDI-573, a dual IGF-I/II neutralizing antibody, in Japanese patients with advanced solid tumours. Invest New Drugs. 2015 Feb;33(1):194-200. doi: 10.1007/s10637-014-0170-x. Epub 2014 Oct 25.

    PMID: 25342141DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

dusigitumab

Study Officials

  • Edward Bradley, MD

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 21, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations

JP(1)