RX-5902 Treatment of Subjects With Triple Negative Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/21/2018
Start Date:August 2013
End Date:January 2019

Use our guide to learn which trials are right for you!

A Multi-Center, Dose Finding, Open Label, Phase 1 Study of RX-5902 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902
identified in the phase 1 to treat subjects with triple negative breast cancer.

In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for
up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by
1 week of rest in each cycle. All subjects will be followed for at least 30 days after the
last dose of study agent for safety.

Inclusion Criteria:

- Male and female who are 18 yrs or older

- Histologically confirmed triple negative breast cancer that are refractory,
intolerant, or ineligible to receive approved standard therapies

- Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors
(RECIST)

- Life expectancy of at least 3 months

- Able to swallow capsules

- Provide written informed consent

Exclusion Criteria:

- Primary brain tumor or active brain metastasis

- Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or
neuropathy) associated with previous cancer therapies

- Any other cancer treatments within 2 weeks of planned study treatment

- History of any medical or psychiatric condition or addictive disorder, or lab
abnormality that in the opinion of the investigator, may increase risks or may
interfere with study participation or interpretation of study results

- History of clinically significant GI bleed, intestinal obstruction, or GI perforation
within 6 months of study dose

- Uncontrolled diabetes

- History of long QT syndrome or clinically significant cardiac arrhythmias (except
stable atrial fibrillation)

- Myocardial infarction within 6 months of study dose

- Active infection requiring IV antibiotics within 2 weeks of study dose

- History of Hepatitis B, C, or HIV

- Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study
treatment or expected requirement for use of such a drug during study

- Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes
within 14 days prior to planned study treatment or expected requirement for use of
such a drug during study

- Receiving other investigational agents or not yet completed 30 days since completion
of an investigational study

- Pregnant, planning a pregnancy, or breast feeding

- Male or female not willing to use adequate contraceptive precautions during the study
period. Females must either be surgically sterile, post-menopausal for 12 months, or
use a contraceptive approved by sponsor.

- Unwilling or unable to provide written informed consent, comply with study
requirements, or be available for follow-up assessments
We found this trial at
8
sites
Arlington, Virginia 22031
?
mi
from
Arlington, VA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
New York, New York 10065
?
mi
from
New York, NY
Click here to add this to my saved trials
Tucson, Arizona 85719
?
mi
from
Tucson, AZ
Click here to add this to my saved trials