Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2019-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SyB C-1101

Group Type EXPERIMENTAL

SyB C-1101

Intervention Type DRUG

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.

Interventions

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SyB C-1101

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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)
4. 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.
5. Patients with expected survival of ≥3 months.
6. Patients aged 20 years or older (at the time of informed consent).
7. ECOG Performance Status (PS) of 0, 1 or 2
8. 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
9. 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No