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A Study of the Effects of ALKS 4230 on Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02799095
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
To better understand the safety and tolerability of ALKS 4230 in humans

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: ALKS 4230 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of ALKS 4230 in Subjects With Advanced Solid Tumors
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: ALKS 4230 Drug: ALKS 4230
Intravenous infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period




Primary Outcome Measures :
  1. Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months ]
    Incidence of AEs that are both serious and drug-related

  2. Incidence of drug-related AEs in study Part B [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) based on investigator review of radiographic or photographic images [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    Proportion of subjects with objective evidence of Complete Response (CR/irCR) or Partial Response (PR/irPR)

  2. Disease Control Rate [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    Proportion of subjects with objective evidence of CR, PR, or Stable Disease (SD)

  3. Duration of response in subjects with CR or PR [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    Time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause

  4. Serum concentrations of ALKS 4230 will be determined at various time points [ Time Frame: From time of initiation of therapy until the last treatment cycle, assessed up to 24 months ]
    Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level

  5. Serum will be assayed for the presence of anti-ALKS 4230 antibodies [ Time Frame: From time of initiation of therapy until the last treatment cycle, assessed up to 24 months ]
    Results will be summarized by dose level

  6. Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points [ Time Frame: From time of initiation of therapy until the last treatment cycle, assessed up to 24 months ]
    Results will be summarized by dose level

  7. Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points [ Time Frame: From time of initiation of therapy during the first two treatment cycles, assessed up to 2 months ]
    Results will be summarized by dose level



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has histological or cytological evidence of 1 of the following solid tumor types: melanoma, renal cell carcinoma, or ovarian cancer
  • All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
  • Subjects enrolled in Part B must have at least 1 lesion that may qualify as a target lesion
  • Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months
  • Subject must have adequate hematologic reserve
  • Subjects must have adequate liver function
  • Subjects must have adequate kidney function
  • Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
  • Subjects who have received investigational agents must wait at least 4 weeks
  • Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as >45 years of age and without a menstrual period for 12 consecutive months
  • Meets contraceptive requirements defined in the protocol
  • Additional criteria may apply

Exclusion Criteria:

  • Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study
  • Subjects with an active infection or with a fever >/+ 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
  • Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable
  • Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
  • Subjects with known hypersensitivity to any components of ALKS 4230
  • Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
  • Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
  • Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study
  • The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C
  • Additional criteria may apply

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): NCT02799095


Contacts
Contact: Sean Rossi 781-609-6013 Sean.Rossi@alkermes.com

Locations
United States, Florida
Alkermes Investigational Site Recruiting
Tampa, Florida, United States, 33610
United States, Massachusetts
Alkermes Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Alkermes Investigational Site Recruiting
Detroit, Michigan, United States, 47201
United States, New York
Alkermes Investigational Site Recruiting
Buffalo, New York, United States, 14203
Alkermes Investigational Site Recruiting
New York, New York, United States, 10016
United States, Ohio
Alkermes Investigational Site - 2 Sites Recruiting
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Lisa von Moltke, MD Alkermes, Inc.

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02799095     History of Changes
Other Study ID Numbers: ALK4230-A101
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Alkermes, Inc.:
Immunotherapy
IL-2
Interleukin-2
Solid tumors