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Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: SyB C-1101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Open-label, Phase I Study of SyB C-1101 in Patients With Myelodysplastic Syndrome
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SyB C-1101 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. Severity of adverse events [ Time Frame: Up to 2 years ]
    Score as grade 1 to 5 according to criteria by CTCAE v4.0-JCOG.

  3. Relationship of adverse events to SyB C-1101 [ Time Frame: Up to 2 years ]
    Score as "related " or "not related".

  4. 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.)

  5. 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.

  6. Overall hematologic improvement rate [ Time Frame: Up to 2 years ]
    Calculate from the rate of patients with hematologic improvement according to IWG 2006 criteria.

  7. 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.

  8. Cmax [ Time Frame: Up to 2 years ]
    Maximum plasma concentration

  9. tmax [ Time Frame: Up to 2 years ]
    Time to maximum plasma concentration

  10. AUC [ Time Frame: Up to 2 years ]
    Area under the plasma concentration curve

  11. t 1/2 [ Time Frame: Up to 2 years ]
    Half-life time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495167


Contacts
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Contact: Moriyoshi Komiya +81-3-5472-1127 mkomiya.mk01@symbiopharma.com

Locations
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Japan
Research Site Recruiting
Nagoya, Aichi, Japan
Research Site Recruiting
Maebashi, Gunma, Japan
Research Site Recruiting
Sapporo, Hokkaido, Japan
Research Site Recruiting
Kobe, Hyogo, Japan
Research Site Recruiting
Kurashiki, Okayama, Japan
Research Site Recruiting
Shinagawa, Tokyo, Japan
Research Site Recruiting
Fukuoka, Japan
Research Site Recruiting
Kumamoto, Japan
Research Site Recruiting
Kyoto, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
Investigators
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Study Director: Katsuhisa Goto SymBio Pharmaceuticals

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Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03495167    
Other Study ID Numbers: 2017001
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms