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

NCT02000154 | Completed Phase 1 Results

• 1 other identifier: 2012001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 9

Brief Summary

This is an extension study study to investigate long term safety of SyB L-1101 when administered intravenously every 4 weeks to the patients who have completed 8 cycles in the study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome. Antitumor effects will also be investigated in this study.

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Total number affected by any adverse events (details are presented in adverse event section)

  Up to 20 weeks

Secondary Outcomes (4)

• Disease Response Assessment

  Up to 20 weeks

• Serious Adverse Events

  Up to 20 weeks

• Hematologic Improvement

  Up to 20 weeks

• Cytogenetic Response

  Up to 20 weeks

Study Arms (1)

SyB L-1101

EXPERIMENTAL

Drug: SyB L-1101

Interventions

SyB L-1101 DRUG

SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.

SyB L-1101

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must satisfy the following conditions listed below.
• Patients enrolled in the study 2011005 of SyB L-1101 in Patients With Myelodysplastic Syndrome.
• Patients who was not judged as disease progression\* nor progressive disease/relapsed\*\* at the end of the cycle 8 in the study 2011005. \* hematologic remission according to IWG 2006 criteria \*\* hematologic improvement according to IWG 2006 criteria
• Patients who met the continuation criteria\*\*\* after Cycle 8 week 2 (Day 15±3) in the study 2011005.\*\*\*defined in the study 2011005 protocol
• Patients who can be expected to survive at least three months or longer.
• Patients who have score of 0 to 2 in Eastern Cooperative Oncology Grou (ECOG) Performance Status (P.S.).
• Patients with adequate function in major organs (heart, lungs, liver, kidneys, etc.).
• Aspartate aminotransferase (AST): no more than 3.0 times the upper boundary of the reference range at each institution
• Alanine aminotransferase (ALT): no more than 3.0 times the upper boundary of the reference range at each institution
• Total bilirubin: no more than 1.5 times the upper boundary of the reference range at each institution
• Serum creatinine: no more than 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
• Patients who personally signed an informed consent document for participation in this study.

You may not qualify if:

• Patients who satisfy any of the following conditions will not be enrolled in the study.
• Patients with anemia (haemolytic anaemia, gastrointestinal haemorrhage, etc.) caused by factors other than MDS.
• Patients with obvious infectious diseases (including viral infections).
• Patients with serious complications (liver failure, renal failure, etc.).
• Patients with a complication of serious heart disease (myocardial infarction, ischemic heart disease, etc.)
• Patients with a serious gastrointestinal condition (severe or significant nausea/vomiting, diarrhea, etc.)
• Patients with serious bleeding tendencies (disseminated intravascular coagulation (DIC), internal hemorrhage, etc.).
• Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of \<130 milliequivalent/L).
• Patients with an addiction to a legal or illegal drug, or with alcohol dependency.
• Patients who are nursing, pregnant or may become pregnant.
• Patients who have not consented to the following contraceptive measures. Patients will avoid sexual intercourse with sexual partners or should use the following contraceptive methods in these time periods: for male patients during the administration period of the trial and for six months after the end of administration; female patients during the administration period of the trial, and until a second menstrual period is confirmed after the end of administration (or in the case of female patients with no menstrual period, for two months after the end of administration). (1) Male patients:The patient will always use a condom. For effective contraception, it is recommended that the female partner also use the contraceptive methods for female patients. (2) Female patients: Female patients who may become pregnant should use one or more types of the following contraceptive methods. In addition, the male partner will always use a condom.
• Oral contraceptive (birth control pills)
• Intrauterine device (IUD)
• Tubal ligation
• Other patients judged to be unsuitable by an investigator or sub-investigator.

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (9)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

Research Site

Kagoshima, Kagoshima-ken, Japan

Location

Research site

Isesaki, Kanagawa, Japan

Location

Research Site

Kumamoto, Kumamoto, Japan

Location

Research Site

Sendai, Miyagi, Japan

Location

Research Site

Kurashiki, Okayama-ken, Japan

Location

Research Site

Kawagoe, Saitama, Japan

Location

Research Site

Tokyo, Tokyo, Japan

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Katsuhisa Goto
• Organization: SymBio Pharmaceuticals

+81-3-5472-1127

Study Officials

• Katsuhisa Goto

  SymBio Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 31, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-02

Locations

JP (9)