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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01279603 on ClinicalTrials.gov