MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is studying a targeted therapy as a possible treatment for merkel cell carcinoma.

• The name of the study intervention involved in this study is: MLN0128.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Millennium Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Metastatic or recurrent MCC confirmed by histology

• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan (see section 10 for the evaluation of measureable disease). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented

• Age 18 years or older

• ECOG performance status ≤ 2

• Participants must have normal organ and marrow function

• Female patients who:

• Are postmenopausal for at least 1 year before the screening visit

--- OR

• Are surgically sterile --- OR

• If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time

• Male patients, even if surgically sterilized (ie, status post-vasectomy), who:

• Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or

• Agree to completely abstain from heterosexual intercourse

• Treatment with strong CYP2C19, CYP3A4, and CYP2C9 inhibitors and/or inducers

• Tissue for correlative studies must be available (paraffinized or frozen)

• Ability to swallow oral medications and maintain an empty stomach state for 2 hours prior to the MLN0128 dose and for 1 hour following administration

• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Participants who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study

• The subject has active brain metastases or epidural disease

• Participants who are receiving any other investigational agents within 14 days before the first dose of study drug

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations

• Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug

• Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of MLN0128

• Poorly controlled diabetes mellitus

• History of any of the following within the last 6 months prior to study entry:

• Ischemic myocardial event

• Ischemic cerebrovascular event

• Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia

• Placement of a pacemaker for control of rhythm

• New York Heart Association (NYHA) Class III or IV heart failure

• Pulmonary embolism

• Significant active cardiovascular or pulmonary disease at the time of study entry, including:

• Uncontrolled high blood pressure

• Pulmonary hypertension

• Uncontrolled asthma

• Significant valvular disease; severe regurgitation or stenosis

• Medically significant (symptomatic) bradycardia

• History of arrhythmia requiring an implantable cardiac defibrillator

• Baseline prolongation of the rate-corrected QT interval (QTc)

• Initiation of treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids