A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by MedImmune LLC
Sponsor:
Collaborator:
Amplimmune
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT02013804
First received: December 12, 2013
Last updated: May 12, 2015
Last verified: May 2015
  Purpose

This is a multicenter, open label, first-in-human dose-escalation study of MEDI0680 (AMP-514) to evaluate the safety, tolerability, PK, immunogenicity (IM), and antitumor activity in adult subjects with solid tumors.


Condition Intervention Phase
Advanced Malignancies
Drug: MEDI0680 (AMP-514)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety and Tolerability; define Maximum Tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The primary objectives are to assess the safety and tolerability of multiple doses of MEDI0680 (AMP-514) and define the maximum tolerated dose (MTD) or highest protocol-defined dose of MEDI0680 (AMP-514) in the absence of exceeding the MTD.


Estimated Enrollment: 48
Study Start Date: December 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose arms Drug: MEDI0680 (AMP-514)
Study has planned dose escalation cohorts

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years of age at time of study entry
  2. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the USA) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
  3. Histologically- or cytologically-confirmed melanoma or clear-cell RCC that are refractory to standard therapy or for which no standard therapy exists

    1. Subjects must have failed, be intolerant to, or be ineligible for any potentially curative approved treatment, irrespective of line of therapy
    2. No more than 3 prior lines of therapy
  4. At least 1 measurable lesion per RECIST v1.1; subjects whose only measurable lesion is a lymph node will be excluded
  5. Eastern Cooperative Oncology Group performance score of 0 or 1
  6. For all tumor types, adequate organ and marrow function, as defined below:

    1. Hemoglobin ³ 9.0 g/dL within first 2 weeks prior to first dose of MEDI0680 (AMP-514)
    2. Absolute neutrophil count (ANC) ³ 1.5 × 109/L (1,500/mm3)
    3. Platelet count ³ 100 × 109/L (100,000/mm3)
    4. Total bilirubin ≤ 1.5 × ULN except subjects with documented Gilbert's syndrome (> 3 × ULN) or liver metastasis, who must have a baseline total bilirubin ≤ 3.0 mg/
    5. Alanine aminotransferase and AST ≤ 2.5 × ULN; for subjects with hepatic metastases, ALT and AST ≤ 5 × ULN
    6. Serum creatinine ≤ 1.5 × ULN OR calculated creatinine clearance (CrCl) or 24-hour urine CrCl ≥ 50 mL/minute ▪ Cockcroft-Gault formula will be used to calculate CrCl; 24-hour urine CrCl will be derived using the measured creatinine clearance formula
  7. Prior treatment toxicities must be ≤ Grade 1

Exclusion Criteria:

  1. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
  2. Receipt of any BRAF inhibitor (in metastatic melanoma), or investigational anticancer therapy within 4 weeks prior to the first dose of MEDI0680 (AMP-514)
  3. Prior exposure to immunotherapy, such as, but not limited to, other anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies, excluding therapeutic cancer vaccines
  4. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of MEDI0680 (AMP-514) or still recovering from prior surgery
  5. Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured
  6. Prior allogeneic or autologous bone marrow or organ transplantation that requires use of immunosuppressives
  7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by MEDI0680 (AMP-514) may be included (eg, hearing loss) after consultation with the MedImmune medical monitor
  8. Active or prior documented autoimmune disease within the past 2 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013804

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: Joyson Karakunnel, MD, MSc, FACP 301-398-1610 karakunnelj@medimmune.com

Locations
United States, Connecticut
Research Site Recruiting
New Haven, Connecticut, United States
United States, Michigan
Research Site Active, not recruiting
Detroit, Michigan, United States
United States, New York
Research Site Recruiting
Bronx, New York, United States
United States, Oregon
Research Site Recruiting
Portland, Oregon, United States
United States, Tennessee
Research Site Active, not recruiting
Nashville, Tennessee, United States
United States, Texas
Research Site Active, not recruiting
Houston, Texas, United States
Sponsors and Collaborators
MedImmune LLC
Amplimmune
Investigators
Study Director: Joyson Karakunnel, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02013804     History of Changes
Other Study ID Numbers: AMP-514-01, D6020C00002 (AMP-514-01)
Study First Received: December 12, 2013
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 01, 2015