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Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors

Thank you

Trial Information


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Severity and number of adverse events related to escalating doses of MM-141

Outcome Description:

Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MM-141-01-01-01

NCT ID:

NCT01733004

Start Date:

November 2012

Completion Date:

August 2014

Related Keywords:

  • Advanced Solid Tumors
  • Cancer
  • Solid tumors
  • Oncology
  • Phase I
  • ErbB3
  • IGF-1R
  • Everolimus
  • Docetaxel
  • Neoplasms

Name

Location

Georgia Cancer SpecialistsDecatur, Georgia  30033
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Karmanos Cancer InstituteDetroit, Michigan  48201