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

Status: Active

Description

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

Eligibility Criteria

Inclusion Criteria

  • For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma
  • 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 or Part C 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 with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only)
  • 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, or active tuberculosis, or has a known history of tuberculosis
  • Additional criteria may apply

Locations & Contacts

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Mayer N. Fishman
Phone: 813-745-8311
Email: mayer.fishman@moffitt.org

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Alkermes, Inc.

Trial IDs

Primary ID ALK4230-A101
Secondary IDs NCI-2016-00981, s15-01394
Clinicaltrials.gov ID NCT02799095