A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas

NCT ID: NCT01284231

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-01-31

Brief Summary

To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal adenocarcinomas who have no available standard or curative treatments.

Detailed Description

This is a FTIH, dose-escalation and expansion Phase 1 study. The first part is a multicenter, open-label, single-arm, dose-escalation study of MEDI-565 to determine the MTD or OBD and evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI 565 in adult subjects who have GI adenocarcinomas for which no standard or curative treatments are available. The second part is a dose-expansion study at the MTD or OBD in subjects with selected tumor types.

Conditions

Gastrointestinal Adenocarcinomas

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEDI-565 - Dose Escalation

Up to 15 dose-escalation cohorts will be enrolled

Group Type: EXPERIMENTAL

MEDI-565

Intervention Type: DRUG

MEDI-565 will be administered by IV infusion

MEDI-565 Dose Expansion Arm 1

20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose

Group Type: EXPERIMENTAL

MEDI-565

Intervention Type: DRUG

20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.

MEDI-565 Dose Expansion Arm 2

20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose

Group Type: EXPERIMENTAL

MEDI-565

Intervention Type: DRUG

20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.

MEDI-565 Dose Expansion Arm 3

Subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biological dose

Group Type: EXPERIMENTAL

MEDI-565

Intervention Type: DRUG

20 Subjects with refractory Gastroesophageal cancer to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.

Interventions

MEDI-565

MEDI-565 will be administered by IV infusion

Intervention Type: DRUG

MEDI-565

20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.

Intervention Type: DRUG

MEDI-565

20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.

Intervention Type: DRUG

MEDI-565

20 Subjects with refractory Gastroesophageal cancer to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years of age at the time of screening
• Adequate contraception from screening through end of trial
• For the dose-escalation phase, subjects with GI adenocarcinomas with no available standard or curative treatments
• Adequate hematological function
• Adequate organ function
• For subjects who had prior treatment with chemotherapy, biological therapy, radiotherapy, or had prior surgery: eligible for study entry if at least 30 days have passed since their treatment/surgery
• Life expectancy of at least 3 months
• Karnofsky performance status ≥ 70%
• Body weight ≥ 45 kg

Exclusion Criteria

• Concurrent enrollment in another clinical study
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
• Prior treatment with MEDI-565
• History of allergy or reaction to any component of the MEDI-565 formulation
• History of malignancy other than GI adenocarcinoma, within 5 years prior to study entry, with the exception of ductal carcinoma in situ of the breast, basal cell carcinoma of the skin or carcinoma in situ of the cervix successfully treated with curative therapy
• Diagnosis of hepatocellular carcinoma
• Clinical history of significant CNS pathology
• Active bacterial infection or known bacteremia.
• Vaccination within 2 weeks prior to initiation of MEDI-565
• Infection with HIV-1 or HIV-2; chronic infection with hepatitis B or C
• History of primary immunodeficiency
• History of chronic autoimmune disease
• Elective surgery planned during the study period through 30 days after discontinuation of MEDI-565.
• Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment within 30 days prior to study entry and not recovered from treatment
• Treatment with any investigational agent within 30 days prior to initiation of MEDI-565
• Regular dose of systemic corticosteroids during the 30 days prior to initiation of MEDI-565 or anticipated need of corticosteroids exceeding prednisone 40 mg/day of prednisone or equivalent during the trial, or any other systemic immunosuppressive therapy within 30 days prior to study entry (some maintenance doses allowed)
• Contraindication to any protocol-specified concomitant medications administered during this study
• Pregnancy or lactation
• Evidence of any uncontrolled systemic disease (other than GI adenocarcinoma)
• Recent history of cardiac disease, including myocardial infarction, unstable angina pectoris or uncontrolled arrhythmia within 6 months, or evidence of severe congestive heart failure
• A marked baseline prolongation of corrected QT interval interval

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer McDevitt

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Research Site

Washington D.C., District of Columbia, United States

Research Site

Augusta, Georgia, United States

Research Site

Durham, North Carolina, United States

Research Site

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

MI-CP216

Identifier Type: -

Identifier Source: org_study_id