Hepatocellular Carcinoma
Conditions
Keywords
Cancer, Hepatocellular Carcinoma, Oncology, Phase I, ErbB3, IGF-1R, Everolimus, Gemcitabine, Abraxane
Brief summary
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a 3+3 design, evaluating MM-141 at varying dose levels and frequencies.
Interventions
DRUGMM-141
Sponsors
Merrimack Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy * Eighteen years of age or above * Able to understand and sign an informed consent (or have a legal representative who is able to do so) * Measurable disease according to RECIST v1.1 * ECOG Performance Score of 0 or 1 * Adequate bone marrow, hepatic, renal and cardiac function * Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141
Exclusion criteria
* Active infection or fever \> 38.5°C during screening visits or on the first scheduled day of dosing * Symptomatic CNS disease * Received other recent antitumor therapy * Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity and number of adverse events related to escalating doses of MM-141 | 2 years | Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies. |
Countries
France, United States
Outcome results
None listed