Evaluate the Safety Profile and Ability of TW1025 Oral Solution to Decrease Fatigue

NCT02645175 | Terminated Phase 2 DMC

• 2 other identifiers: TW1025-201413145
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Breast Cancer; Fatigue

Keywords

Paclitaxel; docetaxel; vinorelbine; eribulin

Outcome Measures

Primary Outcomes (1)

• Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline

  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

  Baseline vs 9 weeks

Secondary Outcomes (1)

• Number of Adverse Events (AEs)

  1 year after discontinuation of study treatment

Other Outcomes (6)

• Change in Fatigue Scores at Baseline vs at 18-weeks

  Baseline vs 18-weeks

• Change in Sleepiness Scores

  Baseline vs 9 weeks

• Change in Quality of Life Scores

  Baseline vs 9 weeks

Study Arms (2)

TW1025

EXPERIMENTAL

TW1025 oral solution, 20ml, 3 times per day (daily dose: 60 ml)

Dietary Supplement: TW1025

Placebo

PLACEBO COMPARATOR

TW1025 oral solution matched placebo, 20ml, 3 times per day

Dietary Supplement: Placebo

Interventions

TW1025 DIETARY_SUPPLEMENT

20ml, 3 times per day (daily dose: 60 ml)

Also known as: Linease oral solution

TW1025

Placebo DIETARY_SUPPLEMENT

20ml, 3 times per day (daily dose: 60 ml)

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pain score of ≤4 on a 1-to-10 linear analog scale
• Insomnia score of ≤4 on a 1-to-10 linear analog scale
• If of childbearing potential, agrees to use reliable contraceptive method(s) during participation in the study
• Estimated life expectancy of at least 6 months
• Has provided written informed consent and HIPAA authorization

You may not qualify if:

• 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
• Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an "adaptogen")
• Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral TW1025/placebo treatment
• Uncontrolled thyroid disorder
• Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (Defined per medical history)
• Any other serious diseases/medical history that would limit the patient's ability to receive study therapy as assessed by the investigator
• Lactating, pregnant, or plans to be become pregnant

Sponsors & Collaborators

• Meriyana Bio Inc.: lead
• US Oncology Research: collaborator

Related Links

• Evaluation of the Safety and Efficacy of THL-P in Metastatic Breast Cancer

MeSH Terms

Conditions

Breast Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joyce O'Shaughnessy, MD

  Texas Oncology-Baylor Charles A. Sammons Cancer Center

  STUDY CHAIR

• Jacqueline Whang-Peng, MD.

  Director, Division of Cancer Center, Wan Fang Hospital, Taiwan

  STUDY DIRECTOR

• Anderson Thomas, MD

  Texas Oncology-Bedford

  PRINCIPAL INVESTIGATOR

• Danso Michael, MD

  Virginia Oncology Associates

  PRINCIPAL INVESTIGATOR

• Encarnacion Carlos, MD

  Texas Oncology-Waco

  PRINCIPAL INVESTIGATOR

• Fleischauer Scott, MD

  Texas Oncology-Arlington North

  PRINCIPAL INVESTIGATOR

• Taguchi Julie, MD

  Sansum Clinic

  PRINCIPAL INVESTIGATOR

• Wang Grace, MD

  Baptist Health Medical Group Oncology, LLC

  PRINCIPAL INVESTIGATOR

• Holmes Frankie, MD

  Texas Oncology-Memorial City

  PRINCIPAL INVESTIGATOR

• Houck William, MD

  Shenandoah Oncology, P.C.

  PRINCIPAL INVESTIGATOR

• Crane Gregory, MD

  The University of Kansas Cancer Center

  PRINCIPAL INVESTIGATOR

• Tsai Michaela, MD

  Minnesota Oncology Hematology, P.A.

  PRINCIPAL INVESTIGATOR

• Vukelja Svetislava, MD

  Texas Oncology-Tyler

  PRINCIPAL INVESTIGATOR

• Lee Jae, MD

  Willamette Valley Cancer Institute and Research Center

  PRINCIPAL INVESTIGATOR

• Smith II John, MD

  Northwest Cancer Specialists, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share