A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety Profile and Ability of TW1025 to Decrease Fatigue
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer
- Sponsor
- Meriyana Bio Inc.
- Enrollment
- 3
- Primary Endpoint
- Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
A randomized, double-blind, placebo-controlled, parallel study to evaluate the safety profile and ability of TW1025 oral solution to decrease fatigue in HER2-negative metastatic breast cancer patients receiving chemotherapy.
Detailed Description
The study population designed to be enrolled is patients with histologically and/or cytologically confirmed breast cancer with clinical evidence of recurrent or progressive HER2-negative metastatic disease and planning to begin a chemotherapy regimen of physician's choice for HER2-negative MBC who have evidence of fatigue. An add-on study design to assess the superiority of TW1025 over placebo will be utilized in this study to evaluate whether TW1025 can decrease fatigue in patients with fatigue. The study will be conducted as a double-blind, randomized trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A patient is eligible for the study if all of the following apply:
- •Female patients at least 18 years of age for study sites in the United States and 20 to 80 years old (inclusive) for study sites in Taiwan
- •Histologically and/or cytologically confirmed HER2-negative breast cancer with clinical evidence of recurrent or progressive metastatic disease
- •Patients may have measurable or nonmeasurable metastatic breast cancer.
- •Planning to begin a new chemotherapy regimen of the physician's choice
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
- •HER2-negative disease per College of American Pathologists (CAP) guidelines (immunohistochemistry (IHC) 0, 1+, or if 2+ fluorescence in-situ hybridization (FISH)-negative ratio \< 2.0)
- •Known ER status: ER-negative (0% of cells positive for ER) or ER-positive (≥1% cells positive for ER) by IHC
- •Adequate bone marrow function (absolute neutrophil count ≥ 1,500 /µL, hemoglobin count ≥ 8 g/dL, and platelet count \> 100,000/µL), total serum bilirubin \< 1.5 mg/dL and SGOT/SGPT less than 5-times the upper limit of normal if liver metastases are present or \< 2.5-times the upper limit of normal if no liver metastases, and serum creatinine \< 1.5 mg/dL
- •Fatigue score of ≥5 on a 1-to-10 linear analog scale
Exclusion Criteria
- •Any patient meeting any of the exclusion criteria will be excluded from study participation:
- •Has received radiotherapy or cytotoxic therapy within 3 weeks
- •Any uncontrolled infection
- •History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma, or multiple sclerosis
- •History of known brain metastases; Screening for brain metastases is not required
- •More than 4 prior cytotoxic chemotherapy regimens for metastatic disease
- •Requirement for ongoing systemic steroid therapy
- •Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc.
- •Note: Antidepressants used to treat items other than fatigue (such as depression or hot flashes) are allowed if the patient has been on a stable dose for ≥ 3 months and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.
- •Pain requiring long-acting continuous release narcotic pain medication; however, short-acting opioids (oxycodone, hydrocodone), tramadol, and over the counter analgesics such as acetaminophen or NSAIDs are allowed
Outcomes
Primary Outcomes
Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline
Time Frame: Baseline vs 9 weeks
Change in fatigue scores at 9 weeks post-initiation of supplementation with TW1025/Placebo compared with baseline, assessed by using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale
Secondary Outcomes
- Number of Adverse Events (AEs)(1 year after discontinuation of study treatment)