Combination Therapy of SyB C-1101 and Azacytidine in Patients With Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a Phase 1 clinical trial to evaluate the tolerability of a combination therapy of SyB C-1101 (rigosertib sodium) and Azacytidine and to determine the recommended dose of SyB C-1101for Phase 2 trial in patients with myelodysplastic syndrome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of SyB C-1101 in Patients With Myelodysplastic Syndrome

NCT03495167

Myelodysplastic Syndrome

COMPLETED PHASE1

Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

NCT02000154

Myelodysplastic Syndrome

COMPLETED PHASE1

Safety and Pharmacokinetics Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)

NCT02014051

Myelodysplastic Syndrome

COMPLETED PHASE1

Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

NCT02002936

Myelodysplastic Syndrome

COMPLETED PHASE1

Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)

NCT01700335

Myelodysplastic Syndrome

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SyB C-1101 and Azacytidine

Group Type EXPERIMENTAL

SyB C-1101 and Azacytidine

Intervention Type DRUG

This study is a multi-center open-label study to assess the tolerability of oral administration of SyB C-1101 twice daily from Day 1 to Day 21 in combination with subcutaneous administration or intravenous drip infusion of azacitidine once daily at a dose of 75 mg/m2 (body surface) for 7 days during the period between Day 8 and Day 16, and to estimate the recommended dose (RD) of C-1101.

SyB C-1101 will be administered at a daily dose of 560 mg or 840 mg in each of the 2 cohorts for a treatment period of 1 cycle for 28 days, including 21 days for SyB C-1101 treatment followed by 7 days of follow-up.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SyB C-1101 and Azacytidine

This study is a multi-center open-label study to assess the tolerability of oral administration of SyB C-1101 twice daily from Day 1 to Day 21 in combination with subcutaneous administration or intravenous drip infusion of azacitidine once daily at a dose of 75 mg/m2 (body surface) for 7 days during the period between Day 8 and Day 16, and to estimate the recommended dose (RD) of C-1101.

SyB C-1101 will be administered at a daily dose of 560 mg or 840 mg in each of the 2 cohorts for a treatment period of 1 cycle for 28 days, including 21 days for SyB C-1101 treatment followed by 7 days of follow-up.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients satisfying all the following criteria will be included:

1. Histologically or cytologically diagnosed with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) Classification or French-American-British (FAB) Classification. As for patients with refractory anemia with excess of blasts in transformation (RAEB-t), however, the peripheral blood white blood cell count is ≤ 25,000 /mm3 or the state of disease was stabilized for at least 4 weeks without treatment.
2. Recognized as Intermediate-1, intermediate-2 or High according to International Prognostic Scoring System (IPSS).
3. ≥4 weeks without treatment or the effect of previous treatment (antitumor effect) is considered to be discontinued after the end of previous therapy for MDS (including using erythropoiesis-stimulating agent, ESA) or other treatment with expectation of antitumor effect.
4. Life expectancy is ≥3 months.
5. ≥20 years of age (at the time of acquiring consent).
6. Have score of 0 to 2 in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS).
7. With adequate function in major organs (heart, lungs, liver, kidneys, etc.).

* Aspartate aminotransferase (AST)(GOT): ≤3.0 times the upper boundary of the reference range at each institution
* Alanine aminotransferase (ALT)(GPT): ≤3.0 times the upper boundary of the reference range at each institution
* Total bilirubin: ≤1.5 times the upper boundary of the reference range at each institution
* Serum creatinine: ≤1.5 times the upper boundary of the reference range at each institution
* ECG: no abnormal findings requiring treatment
* Echocardiography: no abnormal findings requiring treatment
8. Voluntarily sign the written informed consent form to participate in this study.

Exclusion Criteria

Patients satisfying any of the following criteria will be excluded:

1. With anemia (haemolytic anaemia, gastrointestinal haemorrhage, etc.) caused by factors other than MDS.
2. With history or a complication of active malignant tumor (with the exception of target disease) within the past 1 year (basal cell carcinoma or squamous cell carcinoma of skin; or primary squamous cell carcinoma of the cervix or non-invasive breast cancer allows to be registered).
3. Has received administration of granulocyte colony-stimulating factor (G-CSF) within 14 days before the examination for case registration.
4. With an obvious infectious disease (including viral infections).
5. With a serious complication (liver failure, renal failure, etc.).
6. With a complication of serious heart disease (myocardial infarction, symptomatic ischemic heart disease, unstable angina, etc.). With history of arrhythmia within 2 years before registration or arrhythmia that requires treatment.
7. With a serious gastrointestinal condition (severe or significant nausea/vomiting, diarrhea, etc.)
8. Has tested positive for HBsAg or HIV antibody.
9. With serious bleeding tendencies (disseminated intravascular coagulation (DIC), internal hemorrhage, etc.).
10. With accumulation of pleural effusion/ascites that requires treatment such as paracentesis and ect.
11. With hyponatremia (serum sodium is \<130 mEq/L).
12. Has undergone treatment of adrenocortical hormone (corresponding to \>10 mg/24 hr of prednisolone conversion) for \>2 weeks within 4 weeks before starting with administration of the study drug.
13. Has undergone treatment of another investigational product or received chemotherapy, radiotherapy or immunotherapy that was under a clinical trial stage within 3 months before the case registration .
14. Has not recovered from a surgery accompanying general anesthesia or received a surgery accompanying general anesthesia within 3 weeks before the case registration.
15. With not properly controlled hypertension (systolic pressure ≧160 mmHg or diastolic pressure ≧110 mmHg).
16. With not properly controlled epileptic seizure or with onset of epileptic seizure within 3 months before the case registration.
17. Has undergone treatment with SyB 1101 in the past.
18. With history of allergic reaction to polyethylene glycol,gelatin capsule or azacytidine.
19. Difficult to participate in the study treatment due to psychiatric disorder, social condition, ect.
20. With drug intoxication, narcotic addiction or alcohol dependency.
21. Is pregnant, nursing or possibly pregnant.
22. Is positive for pregnancy test (female patients) in the examination before the case registration.
23. Not provided consent to the following contraceptive measures. Patients should avoid sexual intercourse with sexual partners or should use the contraceptive methods as described below in the following time periods: for male patients before case registration until 6 months after the end of administration of the study drug; for female patients with menstruation before case registration until the second menstrual period is confirmed after the end of administration; for menopausal women before case registration until 2 months after the end of administration.

(1) Male patients Must always use a condom. For effective contraception, it is recommended that contraceptive methods should also be applied by the female sexual partner and patient.

(2) Female patients Must use at least 1 of the following contraceptive methods. AT the same time, the male partner must use a condom.

* Oral contraceptive (birth control pill)
* Contraceptive injection
* Contraceptive patch
* Intrauterine device (IUD)
* Tubal ligation 24. Disqualified as a subject of study treatment judged by the principal investigator or investigator.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No