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

NCT ID: NCT02645175

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Metastatic Breast Cancer; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TW1025

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

Group Type: EXPERIMENTAL

TW1025

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

TW1025

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Linease oral solution

Eligibility Criteria

Inclusion Criteria

• A patient is eligible for the study if all of the following apply:

1. 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

2. Histologically and/or cytologically confirmed HER2-negative breast cancer with clinical evidence of recurrent or progressive metastatic disease

3. Patients may have measurable or nonmeasurable metastatic breast cancer.

4. Planning to begin a new chemotherapy regimen of the physician's choice

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2

6. 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)

7. Known ER status: ER-negative (0% of cells positive for ER) or ER-positive (≥1% cells positive for ER) by IHC

8. 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

9. Fatigue score of ≥5 on a 1-to-10 linear analog scale

10. Pain score of ≤4 on a 1-to-10 linear analog scale

11. Insomnia score of ≤4 on a 1-to-10 linear analog scale

12. If of childbearing potential, agrees to use reliable contraceptive method(s) during participation in the study

13. Estimated life expectancy of at least 6 months

14. Has provided written informed consent and HIPAA authorization

Exclusion Criteria

1. Has received radiotherapy or cytotoxic therapy within 3 weeks

2. Any uncontrolled infection

3. History of lupus erythematosus, rheumatoid arthritis, ankylosing spondylosis, scleroderma, or multiple sclerosis

4. History of known brain metastases; Screening for brain metastases is not required

5. More than 4 prior cytotoxic chemotherapy regimens for metastatic disease

6. Requirement for ongoing systemic steroid therapy

7. 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.

8. 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

9. 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")

10. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral TW1025/placebo treatment

11. Uncontrolled thyroid disorder

12. Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (Defined per medical history)

13. Any other serious diseases/medical history that would limit the patient's ability to receive study therapy as assessed by the investigator

14. Lactating, pregnant, or plans to be become pregnant

15. Has received an investigational agent within 4 weeks of entering this study

16. History of adverse reactions to any of the ingredients in TW1025.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

US Oncology Research

INDUSTRY

Sponsor Role: collaborator

Meriyana Bio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce O'Shaughnessy, MD

Role: STUDY_CHAIR

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Jacqueline Whang-Peng, MD.

Role: STUDY_DIRECTOR

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

Anderson Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Oncology-Bedford

Danso Michael, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Oncology Associates

Encarnacion Carlos, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Oncology-Waco

Fleischauer Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Oncology-Arlington North

Taguchi Julie, MD

Role: PRINCIPAL_INVESTIGATOR

Sansum Clinic

Wang Grace, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health Medical Group Oncology, LLC

Holmes Frankie, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Oncology-Memorial City

Houck William, MD

Role: PRINCIPAL_INVESTIGATOR

Shenandoah Oncology, P.C.

Crane Gregory, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Kansas Cancer Center

Tsai Michaela, MD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Oncology Hematology, P.A.

Vukelja Svetislava, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Oncology-Tyler

Lee Jae, MD

Role: PRINCIPAL_INVESTIGATOR

Willamette Valley Cancer Institute and Research Center

Smith II John, MD

Role: PRINCIPAL_INVESTIGATOR

Northwest Cancer Specialists, P.C.

Related Links

https://clinicaltrials.gov/ct2/show/NCT00976365

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

Other Identifiers

13145

Identifier Type: OTHER

Identifier Source: secondary_id

TW1025-2014

Identifier Type: -

Identifier Source: org_study_id