Study of GO-203-2C Given Intravenously in Patients With Advanced Solid Tumors Including Lymphomas
NCT01279603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2014-09-19
Summary
This clinical trial is about testing GO-203-2c, which is a newly discovered compound that binds to an oncoprotein (a cancer causing protein) called MUC1 (which is over-expressed in many cancers). By binding to MUC1, GO-203-2c eventually causes tumor cell death in laboratory studies.
This study is being done to:
* Test the safety of GO-203-2c and see what effects (good and bad) it has on you and your cancer
* Find the highest dose of GO-203-2c that can be given without causing bad side effects
* Examine how much GO-203-2c is in the blood at certain times after it is given and how quickly the body gets rid of it
* Observe whether there is any effect of GO-203-2c on the size and activity of cancer in your body
Conditions
Interventions
- DRUG
-
GO-203-2c
GO-203-2c Injection is a non-preserved, sterile, ready-to-use liquid dosage form provided in a glass vial with rubber closure and crimp seal. Injection will be added to the contents of an intravenous bag (of 0.9% NS, D5W or sterile water) to a final concentration of between 0.03 - 0.3 mg/ml (preferable in 100 mls or greater) and administered as a single agent intravenously over 60 minutes. A treatment cycle will consist of a daily IV dose administered for 21 consecutive days followed by a 7 day rest.
Sponsors & Collaborators
-
Genus Oncology, LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- United States
Study Locations
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