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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01957579
First received: October 1, 2013
Last updated: November 12, 2014
Last verified: November 2014
  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: Allocation: Non-Randomized
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:


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: 20
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957579

Locations
Japan
Research Site
Fukuoka, Japan
Research Site
Isehara-shi, Japan
Research Site
Nagoya-shi, Japan
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
Study Director: Trishna Goswami MedImmune LLC
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01957579     History of Changes
Obsolete Identifiers: NCT01377116
Other Study ID Numbers: D2850C00001
Study First Received: October 1, 2013
Last Updated: November 12, 2014
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:
Hematologic Neoplasms
Neoplasms
Hematologic Diseases
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014