A Study of MEDI-575 in Patients With Advanced Solid Malignancies

NCT ID: NCT01102400

Last Updated: 2013-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).

Detailed Description

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Conditions

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Advanced Solid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

MEDI-575

Intervention Type DRUG

MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part

Interventions

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MEDI-575

MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Having advanced solid malignancy for which no curative or standard therapies exist
* Karnofsky performance status of ≥60
* Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)

Exclusion Criteria

* Inadequate bone marrow reserve or organ function
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
* History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

Research Site

Kashiwa, Chiba, Japan

Site Status

Research Site

Matsuyama, Ehime, Japan

Site Status

Research Site

Chuo-ku, Tokyo, Japan

Site Status

Research Site

Sunto-gun, , Japan

Site Status

Countries

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Japan

References

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Murakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30.

Reference Type DERIVED
PMID: 26223436 (View on PubMed)

Other Identifiers

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D2840C00001

Identifier Type: -

Identifier Source: org_study_id

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