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
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: SyB C-1101||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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
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
|Contact: Moriyoshi Komiyafirstname.lastname@example.org|
|Nagoya, Aichi, Japan|
|Maebashi, Gunma, Japan|
|Sapporo, Hokkaido, Japan|
|Kobe, Hyogo, Japan|
|Kurashiki, Okayama, Japan|
|Shinagawa, Tokyo, Japan|
|Study Director:||Katsuhisa Goto||SymBio Pharmaceuticals|