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

Study identifier:MI-CP216

ClinicalTrials.gov identifier:NCT01284231

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults with Gastrointestinal Adenocarcinomas

Medical condition

Adenocarcinomas

Phase

Phase 1

Healthy volunteers

Study drug

MEDI-565, Dexamethasone

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Dec 2010

Primary Completion Date: 01 Jan 2015

Study Completion Date: 01 Jan 2015

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Age more than or equal to (>=) 18 years of age at the time of screening
- Adequate contraception from screening through end of trial
- For the dose-escalation phase, subjects with gastrointestinal (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 percent (%)
- Body weight >= 45 kilograms (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 central nervous system (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

No locations available

Arms	Assigned Interventions
Experimental: MEDI-565 0.75 mcg MEDI-565 0.75 micorgrams (mcg) as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 2.25 mcg MEDI-565 2.25 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 6.75 mcg MEDI-565 6.75 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 20 mcg MEDI-565 20 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 60 mcg MEDI-565 60 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 120 mcg MEDI-565 120 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 300 mcg MEDI-565 300 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 750 mcg MEDI-565 750 mcg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 1.5 milligram (mg) MEDI-565 1.5 mg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 3 mg MEDI-565 3 mg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 1.5 mg with dexamethasone MEDI-565 1.5 mg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal along with dexamethasone.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 3 mg with dexamethasone MEDI-565 3 mg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal along with dexamethasone.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 5 mg with dexamethasone MEDI-565 5 mg aas intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal along with dexamethasone.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion
Experimental: MEDI-565 7.5 mg with dexamethasone MEDI-565 7.5 mg as intravenous infusion over 3 hours per day, for 5 consecutive days, every 28 days (1 cycle) until documentation of disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for treatment withdrawal along with dexamethasone.	Drug: MEDI-565 MEDI-565 will be administered by IV infusion

Documents available

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CP 216_Protocol v5_Amend 4_Redacted
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Jennifer McDevitt

MedImmune