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A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

This study is currently recruiting participants.
Verified February 2013 by AstraZeneca
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01377116
First received: May 20, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in Japanese patients with relapsed or refractory advanced B-cell malignancies.


Condition Intervention Phase
Blood Cancer
Advanced B Cell Malignancies
 Drug: MEDI-551
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Patients with Adverse Events [ Time Frame: From baseline to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
  • Change from Baseline to 30days after the last ndose of MEDI-551 in laboratory data, vital signs, and ECG [ Time Frame: From baseline to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the drug concentrations in serum and effect on circulating lymphocyte populations and Ig levels [ Time Frame: From baseline to 3 months after the last dose of study drug ] [ Designated as safety issue: No ]
  • Immunogenicity of MEDI-551 by measuring anti-MEDI-551 antibodies [ Time Frame: From baseline to 3 months after the last dose of study drug ] [ Designated as safety issue: No ]
  • Anti-tumor activity of MEDI-551 using Complete Response Rate [ Time Frame: From the baseline to30 days after the last dose of study drug ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: May 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI-551 Drug: MEDI-551
MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese men or women at least 20 years of age
  • Histologically confirmed CLL (excluding small lymphocytic lymphoma (SLL)), DLBCL, FL, or MM.
  • Karnofsky Performance Status ≥70;
  • Life expectancy of ≥12 weeks

Exclusion Criteria:

  • Any available standard line of therapy known to be life-prolonging or life-saving
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
  • Previous therapy directed against CD19, such as monoclonal antibodies or MAb conjugates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377116

Contacts
Contact: AstraZeneca Clinical Study Information 001-800-236-9933 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 001-877-400-4656 astrazeneca@emergingmed.com

Locations
Japan
Research site Recruiting
Nagoya-shi, Aichi, Japan
Research site Recruiting
Isehara, Kanagawa, Japan
Research site Recruiting
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
Study Director: Ramy Ibrahim MedImmune LLC
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01377116     History of Changes
Other Study ID Numbers: D2850C00001
Study First Received: May 20, 2011
Last Updated: February 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase I
advanced
B cell malignancies
 dose escalation
CD19
Japanese

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013