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Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT03495167
Recruitment Status : Unknown
Verified March 2018 by SymBio Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE April 11, 2018
Last Update Posted Date April 11, 2018
Actual Study Start Date  ICMJE October 6, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Identification of Dose-Limiting Toxicity (DLT) and Number of Patients with DLT in Each Cohort [ Time Frame: Up to 2 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Incidence of adverse events [ Time Frame: Up to 2 years ]
    Calculate from the rate between number of patients occurred AE and number of patients received SyB C-1101.
  • Severity of adverse events [ Time Frame: Up to 2 years ]
    Score as grade 1 to 5 according to criteria by CTCAE v4.0-JCOG.
  • Relationship of adverse events to SyB C-1101 [ Time Frame: Up to 2 years ]
    Score as "related " or "not related".
  • Change of laboratory test values [ Time Frame: Up to 2 years ]
    Number of patients with changes in laboratory values OR list each lab value separately (e.g.Hgb, Fe, Hct, etc.)
  • Overall hematologic response rate [ Time Frame: Up to 2 years ]
    Calculate from the rate of patients scored as CR, PR or marrow CR according to IWG 2006 criteria.
  • Overall hematologic improvement rate [ Time Frame: Up to 2 years ]
    Calculate from the rate of patients with hematologic improvement according to IWG 2006 criteria.
  • Overall cytogenetic response rate [ Time Frame: Up to 2 years ]
    Calculate from the rate of patients scored as complete cytogeneic response or partial cytogenetic response according to IWG 2006 criteria.
  • Cmax [ Time Frame: Up to 2 years ]
    Maximum plasma concentration
  • tmax [ Time Frame: Up to 2 years ]
    Time to maximum plasma concentration
  • AUC [ Time Frame: Up to 2 years ]
    Area under the plasma concentration curve
  • t 1/2 [ Time Frame: Up to 2 years ]
    Half-life time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SyB C-1101 in Patients With Myelodysplastic Syndrome
Official Title  ICMJE Multi-center, Open-label, Phase I Study of SyB C-1101 in Patients With Myelodysplastic Syndrome
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelodysplastic Syndrome
Intervention  ICMJE Drug: 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.
Study Arms  ICMJE Experimental: SyB C-1101
Intervention: Drug: SyB C-1101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495167
Other Study ID Numbers  ICMJE 2017001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SymBio Pharmaceuticals
Study Sponsor  ICMJE SymBio Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Katsuhisa Goto SymBio Pharmaceuticals
PRS Account SymBio Pharmaceuticals
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP