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History of Changes for Study: NCT02576548
A Phase 1 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (MEDI4276)
Latest version (submitted June 14, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2015 None (earliest Version on record)
2 January 4, 2016 Contacts/Locations, Study Status and Study Design
3 February 15, 2016 Study Status and Contacts/Locations
4 May 9, 2016 Study Status, Contacts/Locations and Study Design
5 August 25, 2016 Study Status and Study Design
6 September 1, 2016 Study Status and Contacts/Locations
7 November 29, 2016 Study Status, Study Identification, Eligibility, Study Design and Conditions
8 February 10, 2017 Study Status and Eligibility
9 June 9, 2017 Study Status, Oversight and Contacts/Locations
10 September 15, 2017 Study Status
11 October 10, 2017 Study Status
12 November 9, 2017 Study Status
13 December 13, 2017 Study Status
14 January 22, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
15 April 24, 2018 Study Status
16 June 21, 2018 Recruitment Status and Study Status
17 September 13, 2018 Study Status and Study Design
18 June 14, 2019 Arms and Interventions and Study Status
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Study NCT02576548
Submitted Date:  October 12, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: D5760C00001
Brief Title: A Phase 1 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (MEDI4276)
Official Title: A Phase I Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2015
Overall Status: Recruiting
Study Start: September 2015
Primary Completion: June 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: September 28, 2015
First Submitted that
Met QC Criteria:
October 12, 2015
First Posted: October 15, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 12, 2015
Last Update Posted: October 15, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: MedImmune LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.
Detailed Description:
Open or close this module Conditions
Conditions: HER2 Expressing Breast or Gastric (Stomach) Cancers.
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1
MEDI 4276
Biological: MEDI4276
MEDI4276 is an investigational product
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs).
[ Time Frame: From Time of informed consent through 90 days after last dose of MEDI4276 ]

The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
Secondary Outcome Measures:
1. Objective Response Rate (ORR)
[ Time Frame: Time from Informed Consent up to 3 years ]

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
2. Peak Plasma Concentration (Cmax)
[ Time Frame: From first dose of MEDI4276 thorugh to 30 days after last dose of investigational product ]

The immunogenicity of MEDI4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
3. Progression-free survival (PFS)
[ Time Frame: Estimated to be from time of informed consent up to 3 years ]

Progression-free survival will be measured from the start of treatment with MEDI4276 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
4. Overall survival (OS)
[ Time Frame: Estimated to be from time of informed consent up to 3 years ]

Overall survival will be determined as the time from the start of treatment with MEDI4276 until death due to any cause.
5. Area under the plasma concentration versus time curve (AUC)
[ Time Frame: From first dose of MEDI4276 through to 30 days after the last dose of investigational product ]

The immunogencity of MEDI 4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. ≥ 18 years
  2. Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy or for which no standard therapy exists
  3. HER2 Positive disease documented as in situ hybridization (ISH)-positive and or 3+ by IHC on previously collected tumor tissue.
  4. Subjects with primary tumor that is hormone (estrogen, progesterone or both) receptor positive or receptor negative are eligible
  5. Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.

Exclusion Criteria:

  1. Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.
  2. History of Congestive Heart Failure
  3. History of exposure to the following cumulative doses of anthracyclines:
    1. Doxorubicin or liposomal doxorubicin >500 mg/m²
    2. Epirubicin >900mg/m²
    3. Mitoxantrone >120 mg/m² and idarubicin > 90mg/m²
    4. If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 500mg/m² of doxorubicin
  4. Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery or other therapy to control symptoms from brain metastases within 2 months prior to first dose of MEDI4276.
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Study Officials: MedImmune LLC
Study Director
Sponsor GmbH
Locations: United States, California
Stanford University
[Not yet recruiting]
Standford, California, United States, 94305
Contact:Contact: Pei-Jen Chang 650-725-0866 peijenc@standford.edu
Contact:Principal Investigator: Mark Pegram
United States, Florida
Sarah Cannon Research Institute
[Not yet recruiting]
Sarasota, Florida, United States, 34232
Contact:Contact: Jill Martin 941-377-9993 jimartin@flcancer.com
Contact:Principal Investigator: Manish Patel
United States, Indiana
Indiana University
[Not yet recruiting]
Indianapolis, Indiana, United States, 46202
Contact:Contact: LaTrice Vaughn 317-278-3730 lgvaughn@iupui.edu
Contact:Principal Investigator: Anna Storniolo
United States, North Carolina
Levine Cancer Institute
[Not yet recruiting]
Charlotte, North Carolina, United States, 28204
Contact:Contact: Deborah Lewis 980-442-2383 deborah.lewis@carolinashealthcare.org
Contact:Principal Investigator: Antoinette Tan
United States, Tennessee
Sarah Cannon Research Institute
[Recruiting]
Nashville, Tennessee, United States, 37203
Contact:Contact: Blanca Gonzalez 615-524-4463 blanca.gonzalez@scresearch.net
Contact:Principal Investigator: Erika Hamilton
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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