Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

Phase 1

Completed

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: SyB C-1101

• Registration Number: NCT03495167
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-06
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Primary Completion: 2019-05-28
• Study Completion: 2019-05-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SyB C-1101	SyB C-1101	-

Primary Outcome Measures

Name	Time	Method
Identification of Dose-Limiting Toxicity (DLT) and Number of Patients with DLT in Each Cohort	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

Name	Time	Method
Severity of adverse events	Up to 2 years	Score as grade 1 to 5 according to criteria by CTCAE v4.0-JCOG.
Change of laboratory test values	Up to 2 years	Number of patients with changes in laboratory values OR list each lab value separately (e.g.Hgb, Fe, Hct, etc.)
t 1/2	Up to 2 years	Half-life time
Relationship of adverse events to SyB C-1101	Up to 2 years	Score as "related " or "not related".
Overall hematologic response rate	Up to 2 years	Calculate from the rate of patients scored as CR, PR or marrow CR according to IWG 2006 criteria.
Overall cytogenetic response rate	Up to 2 years	Calculate from the rate of patients scored as complete cytogeneic response or partial cytogenetic response according to IWG 2006 criteria.
Incidence of adverse events	Up to 2 years	Calculate from the rate between number of patients occurred AE and number of patients received SyB C-1101.
tmax	Up to 2 years	Time to maximum plasma concentration
Overall hematologic improvement rate	Up to 2 years	Calculate from the rate of patients with hematologic improvement according to IWG 2006 criteria.
Cmax	Up to 2 years	Maximum plasma concentration
AUC	Up to 2 years	Area under the plasma concentration curve

Trial Locations

Locations (1)

Research Site; 🇯🇵 Kyoto, Japan