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


Phase 1
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Adenocarcinomas

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Trial Information

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


Inclusion Criteria:



- Age ≥ 18 years of age at the time of screening

- Written informed consent and any locally required authorization prior to performing
any protocol-related procedures

- Adequate contraception from screening through end of trial

- For the dose-escalation phase, subjects with GI adenocarcinomas with no available
standard or curative treatments

- For the dose-expansion phase, subjects must have CRC or pancreatic adenocarcinoma
confirmed by prior pathological assessment 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:

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or
study results

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerable dose (MTD) or optimal biological dose (OBD) of MEDI-565 in subjects with gastrointestinal (GI) adenocarcinomas for which no standard or curative treatments are available.

Outcome Description:

MTD/OBD will be determined based on Dose Limiting Toxicities that will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle

Outcome Time Frame:

MTD or OBD is reached (28 Days from dose-DLT assessment)

Safety Issue:

No

Principal Investigator

Ramy Ibrahim, MD

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

MI-CP216

NCT ID:

NCT01284231

Start Date:

January 2011

Completion Date:

June 2016

Related Keywords:

  • Gastrointestinal Adenocarcinomas
  • Gastrointestinal adenocarcinomas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Research SiteWashington, District of Columbia  
Research SiteAlbany, Georgia  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania