Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03495167
Other study ID # 2017001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 6, 2017
Est. completion date May 28, 2019

Study information

Verified date November 2022
Source SymBio Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 28, 2019
Est. primary completion date May 28, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Japan Research Site Fukuoka
Japan Research Site Kobe Hyogo
Japan Research Site Kumamoto
Japan Research Site Kurashiki Okayama
Japan Research Site Kyoto
Japan Research Site Maebashi Gunma
Japan Research Site Nagoya Aichi
Japan Research Site Sapporo Hokkaido
Japan Research Site Shinagawa Tokyo

Sponsors (1)

Lead Sponsor Collaborator
SymBio Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of Dose-Limiting Toxicity (DLT) and Number of Patients with DLT in Each Cohort 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.
Up to 2 years
Secondary Incidence of adverse events Calculate from the rate between number of patients occurred AE and number of patients received SyB C-1101. Up to 2 years
Secondary Severity of adverse events Score as grade 1 to 5 according to criteria by CTCAE v4.0-JCOG. Up to 2 years
Secondary Relationship of adverse events to SyB C-1101 Score as "related " or "not related". Up to 2 years
Secondary Change of laboratory test values Number of patients with changes in laboratory values OR list each lab value separately (e.g.Hgb, Fe, Hct, etc.) Up to 2 years
Secondary Overall hematologic response rate Calculate from the rate of patients scored as CR, PR or marrow CR according to IWG 2006 criteria. Up to 2 years
Secondary Overall hematologic improvement rate Calculate from the rate of patients with hematologic improvement according to IWG 2006 criteria. Up to 2 years
Secondary Overall cytogenetic response rate Calculate from the rate of patients scored as complete cytogeneic response or partial cytogenetic response according to IWG 2006 criteria. Up to 2 years
Secondary Cmax Maximum plasma concentration Up to 2 years
Secondary tmax Time to maximum plasma concentration Up to 2 years
Secondary AUC Area under the plasma concentration curve Up to 2 years
Secondary t 1/2 Half-life time Up to 2 years
See also
  Status Clinical Trial Phase
Completed NCT04022785 - PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Phase 1
Completed NCT01200355 - Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome Phase 4
Active, not recruiting NCT02530463 - Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome Phase 2
Completed NCT02057185 - Occupational Status and Hematological Disease
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT02485535 - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant Phase 1
Completed NCT03941769 - 2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II Phase 1/Phase 2
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Completed NCT00987480 - Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine Phase 2
Recruiting NCT02356159 - Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation Phase 1/Phase 2
Active, not recruiting NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Completed NCT02756572 - Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Completed NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Completed NCT02188290 - Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation N/A
Completed NCT02262312 - Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome Phase 0
Recruiting NCT02330692 - Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
Completed NCT01684150 - A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving Phase 1
Completed NCT01462578 - Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza) Phase 2