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

Completed · Phase 1

Conditions studied: HER2 Expressing Breast or Gastric/Stomach Cancers

In brief

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

Key facts

Study ID

NCT02576548

Run by

MedImmune LLC

People needed

47

Starts

2015-09-23

Expected to finish

2018-05-23

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy.
• 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.
• For subjects with gastric cancer:
• Prior treatment with a trastuzumab containing chemotherapy regimen is required.
• HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue.
• At least one lesion measurable by RECIST Version 1.1.

You may not qualify if…

• Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI4276.
• History of exposure to the following cumulative doses of anthracyclines:
• Doxorubicin or liposomal doxorubicin >350 mg/m².
• Epirubicin >530 mg/m².
• Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m².
• 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.
• 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.

Where it is running

• Research Site — Stanford, California, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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