A Phase 1, Dose Escalation Study of MLN7243 in Adult Patients With Advanced Solid Tumors

Status: Recruiting
Phase:
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT02045095 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-013

 

This is an open-label, multicenter, phase 1, dose escalation study with expansion cohorts that will evaluate the safety (establish the MTD and inform the RP2D), tolerability, PK, pharmacodynamics, and antitumor activity of MLN7243 in patients with advanced malignant solid tumors.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Geoffrey Shapiro, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or female patients 18 years or older. 2. Patients must have a histologically confirmed diagnosis of an advanced, metastatic malignant solid tumor and must have failed or exhausted standard therapies or for which no standard therapy is available. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Patients with adequate hematologic and organ function 5. All patients must have radiographically detectable tumors; however, measurable disease as defined by RECIST (version 1.1) is not required for participation in the dose escalation part of this study. 6. Patients undergoing a biopsy procedure must have accessible lesions which are safe to biopsy. 7. Recovered (ie, ≤ Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy, except alopecia. 8. Female patients who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 4 months after the last dose of study drug, or agree to practice true abstinence. Male patients who agree to practice effective barrier contraception during the entire study treatment period through 4 months after the last dose of study drug or agree to practice true abstinence. 9. Suitable venous access for the study-required blood sampling including PK sampling. Exclusion Criteria Patients meeting any of the following exclusion criteria are not to be enrolled in the study: 1. Patients with clinically significant pre-existing cardiac impairment. 2. Patients with known active CNS lesions are excluded. Systemic antineoplastic therapy or investigational agents within 21 days before the first dose of study drug. 3. Radiotherapy within 14 days before the first dose of study drug is not allowed except for limited field radiotherapy for palliative bone pain. 4. For patients where tumor biopsies are required or requested: - Any known coagulation abnormalities that would contraindicate the tumor biopsy procedure. - Ongoing therapy with any anticoagulant or antiplatelet agents (eg, aspirin, clopidogrel [Plavix®], heparin, or warfarin). 5. Major surgery within 28 days before the first dose of MLN7243. 6. Life-threatening illness unrelated to cancer. 7. Any evidence of active infection or antibiotic therapy within 14 days before the first dose of MLN7243. 8. Known human immunodeficiency virus (HIV) positivity or AIDS-related illness, hepatitis B virus, and hepatitis C virus. 9. Patients whose weight is <40 kg. 10. History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease. 11. Female patients who are 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. For the exhaustive list, please contact the study central contact.
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