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

Blood Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957579
• Other study ID #: D2850C00001
• Status: Completed
• Phase: Phase 1
• First received: October 1, 2013
• Last updated: November 4, 2015
• Start date: May 2011
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT01377116

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 130 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced B Cell Malignancies
• Blood Cancer
• Hematologic Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka
Japan	Research Site	Isehara-shi
Japan	Research Site	Nagoya-shi

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	MedImmune LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Adverse Events		From baseline to 30 days after the last dose of study drug	Yes
Primary	Change from Baseline to 30days after the last ndose of MEDI-551 in laboratory data, vital signs, and ECG		From baseline to 30 days after the last dose of study drug	Yes
Secondary	To characterize the drug concentrations in serum and effect on circulating lymphocyte populations and Ig levels		From baseline to 3 months after the last dose of study drug	No
Secondary	Immunogenicity of MEDI-551 by measuring anti-MEDI-551 antibodies		From baseline to 3 months after the last dose of study drug	No
Secondary	Anti-tumor activity of MEDI-551 using Complete Response Rate		From the baseline to30 days after the last dose of study drug	No