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Trial record 1 of 3 for:    MEDI0680
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A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02013804
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Malignancies Drug: MEDI0680 (AMP-514) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : December 19, 2013
Actual Primary Completion Date : May 18, 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose arms
Dose Escalation
 Drug: MEDI0680 (AMP-514)
Study has planned dose escalation cohorts


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability; define Maximum Tolerated dose [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013804


Locations
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United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06511
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, New York
Research Site
The Bronx, New York, United States, 10461
United States, Oregon
Research Site
Portland, Oregon, United States, 97213
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
MedImmune LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02013804    
Other Study ID Numbers: AMP-514-01
D6020C00002 (AMP-514-01) ( Other Identifier: MedImmune )
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Neoplasms