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A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (MEDI4276)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576548
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.

Condition or disease Intervention/treatment Phase
HER2 Expressing Breast or Gastric/Stomach Cancers Biological: MEDI4276 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 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
Actual Study Start Date : September 23, 2015
Actual Primary Completion Date : May 23, 2018
Actual Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDI4276 0.05 mg/kg
Participants received IV dose of 0.05 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.1 mg/kg
Participants received IV dose of 0.1 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.2 mg/kg
Participants received IV dose of 0.2 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.3 mg/kg
Participants received IV dose of 0.3 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.4 mg/kg
Participants received IV dose of 0.4 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.5 mg/kg
Participants received IV dose of 0.5 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.6 mg/kg
Participants received IV dose of 0.6 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.75 mg/kg
Participants received IV dose of 0.75 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product

Experimental: MEDI4276 0.9 mg/kg
Participants received IV dose of 0.9 mg/kg MEDI4276 every three weeks (Q3W) for 2 years.
Biological: MEDI4276
MEDI4276 is an investigational product




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).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy.

    1. For subjects with breast cancer:

      • Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in combination, is required.
      • Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible.
      • Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI4276.
    2. For subjects with gastric cancer:

      • Prior treatment with a trastuzumab containing chemotherapy regimen is required.
  3. HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue.
  4. At least one lesion measurable by RECIST Version 1.1.

Exclusion Criteria:

  1. Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.
  2. History of exposure to the following cumulative doses of anthracyclines:

    1. Doxorubicin or liposomal doxorubicin >350 mg/m².
    2. Epirubicin >530 mg/m².
    3. Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m².
    4. If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576548


Locations
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United States, California
Research Site
Stanford, California, United States, 94305
United States, Florida
Research Site
Sarasota, Florida, United States, 34232
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28204
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: MedImmune LLC Sponsor GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02576548    
Other Study ID Numbers: D5760C00001
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases