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Metastatic Breast CancerPhase 2NCT02645175

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

A Phase 2 study testing TW1025 in people with Metastatic Breast Cancer and Fatigue, run by Meriyana Bio Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Metastatic Breast Cancer, Fatigue
What is being tested?
TW1025
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
No sites listed yet
Study dates
Jan 2016to Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Has received an investigational agent within 4 weeks of entering this study
  • History of adverse reactions to any of the ingredients in TW1025.

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Safety Profile and Ability of TW1025 to Decrease Fatigue

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.

Read the 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.

Being tested
TW1025, Placebo
Keywords
Paclitaxel, docetaxel, vinorelbine, eribulin
Medical subject headings
Breast Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TW1025Dietary supplement

    Also called Linease oral solution

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

  • PlaceboDietary supplement

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

Study groups in NCT02645175
Study groupRoleWhat they receive
TW1025ExperimentalTW1025 oral solution, 20ml, 3 times per day (daily dose: 60 ml)
Receives: Dietary Supplement: TW1025
PlaceboPlacebo comparatorTW1025 oral solution matched placebo, 20ml, 3 times per day
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline vs 9 weeks

Secondary outcomes (1)

  1. Number of Adverse Events (AEs)

    Adverse events (side effects) in each arm will be counted and compared

    Measured: 1 year after discontinuation of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02645175
Sponsor's protocol ID
TW1025-2014
Other IDs
13145
Status last verified
Oct 2016
First submitted
22 Dec 2015
Last updated
21 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Each study site has at least three monitors for the study and all of data will send to Data Center in DSG immediately for all study physicians reference.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TW1025 in people with Metastatic Breast Cancer and Fatigue, run by Meriyana Bio Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue scores at 9 weeks post-supplement initiation (+/- 1 week) compared with baseline (time frame: Baseline vs 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02645175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.

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