A Phase 1, Dose Escalation Study of MLN7243 in Adult Patients With Advanced Solid Tumors
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Geoffrey Shapiro, MD, PhD,
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute:
Andrew Wolanski, 617-632-6623,
Each patient must meet all of the following inclusion criteria to be enrolled in the
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
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.
Patients meeting any of the following exclusion criteria are not to be enrolled in the
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
- 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
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.