PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED STUDY OF THE EFFECT OF GTx-024 ON MUSCLE WASTING IN PATIENTS WITH NON-SMALL CELL LUNG CANCER ON FIRST LINE PLATINUM PLUS A NON-TAXANE CHEMOTHERAPY

Not Applicable

• Registration Number: PER-101-11
• Lead Sponsor: GTx, Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

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 < 300 POUND (< 136 KG).
3. HAVE BEEN DIAGNOSED WITH STAGE III OR IV NSCLC.
4. BE PRIOR TO FIRST LINE CHEMOTHERAPY.
5. PLANNED FIRST-LINE CHEMOTHERAPY REGIMEN IS PLATINUM PLUS GEMCITABINE ONLY OR PLATINUM PLUS VINORELBINE ONLY OR PLATINUM PLUS PEMETREXED ONLY.
6. IF SURGERY IS PART OF THE CANCER TREATMENT, SCREENING FOR THIS STUDY SHOULD BE CONDUCTED AT LEAST 4 WEEKS (28 DAYS) AFTER SURGERY.
7. LIFE EXPECTANCY OF > 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified