HER2 Expressing Breast or Gastric/Stomach Cancers Clinical Trial
— MEDI4276Official 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
| Verified date | June 2019 |
| Source | MedImmune LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | May 23, 2018 |
| Est. primary completion date | May 23, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| MedImmune LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs). | 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. | From Time of informed consent through 90 days after last dose of MEDI4276 | |
| Secondary | Objective Response Rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR | Time from Informed Consent up to 3 years | |
| Secondary | Peak Plasma Concentration (Cmax) | The immunogenicity of MEDI4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of MEDI4276 thorugh to 30 days after last dose of investigational product | |
| Secondary | Progression-free survival (PFS) | 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. | Estimated to be from time of informed consent up to 3 years | |
| Secondary | Overall survival (OS) | Overall survival will be determined as the time from the start of treatment with MEDI4276 until death due to any cause. | Estimated to be from time of informed consent up to 3 years | |
| Secondary | Area under the plasma concentration versus time curve (AUC) | The immunogencity of MEDI 4276 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). | From first dose of MEDI4276 through to 30 days after the last dose of investigational product |