None listed
Conditions
Interventions
UBJECTS WILL BE EVENLY RANDOMIZED TO PLACEBO OR GTx-024 PRIOR TO INITIATION OF FIRST LINE CHEMOTHERAPY. THE PRIMARY EFFICACY ANALYSIS WILL BE BASED ON TOTAL LBM AND PHYSICAL FUNCTION RESPONSES AS ASSE
Sponsors
GTx, Inc.,
Eligibility
Sex/Gender
All
Age
30 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. GIVE VOLUNTARY, SIGNED INFORMED CONSENT IN ACCORDANCE WITH INSTITUTIONAL POLICIES. 2. BE NON-OBESE, AS DEFINED AS BODY MASS INDEX (BMI) ≤ 32 AND WEIGHT 6 MONTHS. 8. ECOG SCORE ECOG ≤ 1. 9. SERUM CREATININE ≤ 2.0 mg/dL. 10. MALES - AGE ≥ 30 YEARS. 11. FEMALES - AGE ≥ 30 YEARS AND CLINICALLY CONFIRMED AS POSTMENOPAUSAL. SUBJECTS MUST HAVE UNDERGONE THE ONSET OF SPONTANEOUS OR SURGICAL MENOPAUSE PRIOR TO THE START OF THIS STUDY. SPONTANEOUS MENOPAUSE IS DEFINED AS THE NATURAL CESSATION OF OVARIAN FUNCTION AS INDICATED BY BEING AMENORRHEIC FOR AT LEAST 12 MONTHS.
Exclusion criteria
Exclusion criteria: 1. HAVE, IN THE JUDGMENT OF THE INVESTIGATOR, A CLINICALLY SIGNIFICANT CONCURRENT ILLNESS OR PSYCHOLOGICAL, FAMILIAL, SOCIOLOGICAL, GEOGRAPHICAL OR OTHER CONCOMITANT CONDITION THAT WOULD NON PERMIT ADEQUATE FOLLOW-UP AND COMPLIANCE WITH THE STUDY PROTOCOL. 2. HAVE ALT/SGOT OR AST/SGPT ABOVE 1.5 TIMES THE UPPER LIMIT OF NORMAL (ULN) WITHOUT EVIDENCE OF LIVER METASTASES AND ABOVE 5 TIMES THE ULN IN SUBJECTS WITH EVIDENCE OF LIVER METASTASES. 3. HAVE ALKALINE PHOSPHATASE GREATER THAN 3 TIMES ULN AND/OR TOTAL BILIRUBIN LEVELS ABOVE 2 mg/dL AT BASELINE. 4. HAVE BIOLOGIC AGENTS OR KINASE INHIBITORS AS PART OF THEIR FIRST LINE CHEMOTHERAPY REGIMEN INCLUDING, BUT NOT LIMITED TO BEVACIZUMAB (AVASTIN®), GEFITINIB (IRESSA®) AND ERLOTINIB (TARCEVA®). 5. CARDIOVASCULAR: UNCONTROLLED HYPERTENSION, CONGESTIVE HEART FAILURE OR ANGINA. 6. PULMONARY: STAGE 4 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). 7. POSITIVE SCREEN FOR HEPATITIS B CONSISTING OF HBsAg (HEPATITIS B SURFACE ANTIGEN), UNLESS SUBJECT WAS DIAGNOSED > 10 YEARS PRIOR TO ENROLLMENT AND NO EVIDENCE OF ACTIVE LIVER DISEASE.
Countries
United States
Contacts
Public ContactLEOPOLDO VALDEZ
ACTIVA CRO PERU SOCIEDAD ANONIMA CERRADA
Outcome results
None listed