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Myelodysplastic SyndromePhase 1NCT03495167

Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

A Phase 1 study testing SyB C-1101 in people with Myelodysplastic Syndrome, run by SymBio Pharmaceuticals at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Myelodysplastic Syndrome
What is being tested?
SyB C-1101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
9 sitesJapan
Study dates
6 Oct 2017to 28 May 2019
Phase
Phase 1
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Patients who meet all of the following criteria are eligible for enrollment in the study:

  1. Histologically or cytologically diagnosed as myelodysplastic syndrome (MDS) according to WHO criteria or FAB classification. For patients with RAEB in transformation (RAEB-t), peripheral WBC is ≦25,000 /mm3 and the disease is stable for at least 4 weeks.
  2. Classified as Intermediate-1, Intermediate-2 or High-risk, according to IPSS classification.
  3. Patients with a history of previous treatment of the target disease (e.g., immunosuppressive therapy, protein anabolic steroids, and chemotherapy including azacitidine and lenalidomide) and meet one of the followings:
  • Patients who failed to achieve complete remission, partial remission, or hematologic improvement*
  • Patients experienced with recurrence/relapse after achieving complete remission, partial remission, or hematologic improvement*
  • Patients who were intolerable to the previous therapy *: The most recent assessment of the therapeutic effect based on "Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia" (IWG2006 criteria)
  1. Off all other treatment (including erythropoiesis stimulating agents) for MDS, for at least 4 weeks prior to enrollment and no carry-over (of antitumor effect) from previous treatment is expected as judged by Investigator. Transfusion is allowed, as clinically indicated.
  2. Patients with expected survival of ≥3 months.
  3. Patients aged 20 years or older (at the time of informed consent).
  4. ECOG Performance Status (PS) of 0, 1 or 2
  5. Patients with adequate major organ functions (including the heart, lungs, liver, and kidneys).
  • AST (GOT): ≤2.5 -fold the upper limit of normal range at each institution
  • ALT (GPT) : ≤2.5 -fold the upper limit of normal range at each institution
  • Total bilirubin: <2.0 mg/dL (except patients with Gilbert's disease or hemolysis)
  • Serum creatinine: <2.0 mg/dL
  • ECG: Absence of abnormal findings that require treatment
  • Echocardiography: Absence of abnormal findings that require treatment
  1. The patient must sign an informed consent form indicating that s/he understands the purpose of and procedure required for the study and is willing to participate in the study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Research Site

    Fukuoka

  • Research Site

    Kobe, Hyōgo

  • Research Site

    Kumamoto

  • Research Site

    Kurashiki, Okayama-ken

  • Research Site

    Kyoto

  • Research Site

    Maebashi, Gunma

  • Research Site

    Nagoya, Aichi-ken

  • Research Site

    Sapporo, Hokkaido

  • Research Site

    Shinagawa, Tokyo

Other trials in Japan

About this study

Official title: Multi-center, Open-label, Phase I Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics.

Being tested
SyB C-1101
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • SyB C-1101Drug

    SyB C-1101 (rigosertib sodium) will be administered to two cohorts of patients; each receives either twice daily (560 mg before breakfast and 560 mg before dinner) or twice daily (840 mg before breakfast and 280 mg before dinner. SyB C-1101 will be administered orally twice daily for 21 consecutive days, followed by a 7-day observation period. The treatment period of 28 days (21 days of administration + 7 days of observation) constitutes 1 cycle.

Study groups in NCT03495167
Study groupRoleWhat they receive
SyB C-1101ExperimentalNot described
Receives: Drug: SyB C-1101

What is being measured

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

  1. Identification of Dose-Limiting Toxicity (DLT) and Number of Patients with DLT in Each Cohort

    Based on the number of patients with DLT and administration dose in each cohort, recommended dosage will be defined for the following clinical phase.

    A DLT is defined as an adverse event that occurred during the Cycle 1, for which a causality with the investigational products (IP) cannot be ruled out and meets the following criteria.

    Criteria: ≥ Grade3 non-hematological toxicity (except pyrexia). However nausea, vomiting, diarrhea, stomatitis and esophagitis/dysphagia are excluded (≥ Grade 3 nausea, vomiting, and diarrhea persist for ≥ 48 hours and uncontrolled by antiemetic or antidiarrheal agents, and ≥ Grade 3 stomatitis and esophagitis/dysphagia lasting for ≥ 4 days are regarded as DLTs). ≥ Grade 2 pyrexia uncontrolled by antipyretic agents. However, in case pyrexia of ˃ 39°C occurred within 24 hours after administration of SyB C-1101 and its cause is unclear, it is deemed that the causality to the IP cannot be ruled out.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Incidence of adverse events

    Calculate from the rate between number of patients occurred AE and number of patients received SyB C-1101.

    Measured: Up to 2 years

  2. Severity of adverse events

    Score as grade 1 to 5 according to criteria by CTCAE v4.0-JCOG.

    Measured: Up to 2 years

  3. Relationship of adverse events to SyB C-1101

    Score as "related " or "not related".

    Measured: Up to 2 years

  4. Change of laboratory test values

    Number of patients with changes in laboratory values OR list each lab value separately (e.g.Hgb, Fe, Hct, etc.)

    Measured: Up to 2 years

  5. Overall hematologic response rate

    Calculate from the rate of patients scored as CR, PR or marrow CR according to IWG 2006 criteria.

    Measured: Up to 2 years

  6. Overall hematologic improvement rate

    Calculate from the rate of patients with hematologic improvement according to IWG 2006 criteria.

    Measured: Up to 2 years

  7. Overall cytogenetic response rate

    Calculate from the rate of patients scored as complete cytogeneic response or partial cytogenetic response according to IWG 2006 criteria.

    Measured: Up to 2 years

  8. Cmax

    Maximum plasma concentration

    Measured: Up to 2 years

  9. tmax

    Time to maximum plasma concentration

    Measured: Up to 2 years

  10. AUC

    Area under the plasma concentration curve

    Measured: Up to 2 years

  11. t 1/2

    Half-life time

    Measured: Up to 2 years

Timeline

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

  1. First posted11 Apr 2018
  2. Study start6 Oct 2017
  3. Primary completion28 May 2019
  4. Study completion28 May 2019

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495167
Sponsor's protocol ID
2017001
Status last verified
Nov 2022
First submitted
17 Nov 2017
Last updated
16 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SyB C-1101 in people with Myelodysplastic Syndrome, run by SymBio Pharmaceuticals at 9 sites in Japan.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Identification of Dose-Limiting Toxicity (DLT) and Number of Patients with DLT in Each Cohort (time frame: Up to 2 years). 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 NCT03495167.

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 16 Nov 2022.

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