Study of DSP-7888 in Patients With Myelodysplastic Syndrome

NCT02436252 | Completed Phase 1

• 1 other identifier: DB650027
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 16

Brief Summary

This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with MDS for whom no effective therapies currently exist.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; MDS

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT)

  Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT)

  12 months

• Overall Survival （OS）

  Participants follow-up for overall survival will occur. Maximum follow-up time is 2 year after the initial administration of the last subject.

  24 months

Secondary Outcomes (4)

• Overall Response Rate（ORR）

  6 months

• TI （Blood transfusion independence）

  6 months

• Time to transformation to AML

  24 months

• Biomarkers

  6 months

Study Arms (1)

DSP-7888

EXPERIMENTAL

Drug: DSP-7888

Interventions

DSP-7888 DRUG

3.5-10.5 mg/body,Id every 2-4 weeks

DSP-7888

Eligibility Criteria

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

You may qualify if:

• \[For Phase 1 part only\]
• Patients with a diagnosis of MDS according to either the fourth edition of the WHO classification or the FAB classification, with the exception of those with chronic myelomonocytic leukemia (CMML) or refractory anemia with excess blasts in transformation (RAEB-t)
• Patients with an International Prognostic Scoring System (IPSS) score of ≧ 1.5 at enrollment, or patients with an IPSS score of \< 1.5 who require additional treatment to supportive therapy in the opinion of the investigator or subinvestigator.
• Patients who will be able to be hospitalized from the initial dose of DSP-7888 until the end of the post-initial dose observation (Patients may be permitted to have a temporary overnight leave during the hospitalization.)
• \[For Phase 2 part only\]
• Patients with a diagnosis of MDS according to either the fourth edition of the WHO classification or the FAB classification
• Patients with an IPSS score of ≧ 1.5 at enrollment, or patients with an IPSS score of \< 1.5 with myeloblasts ≧ 5%
• Patients who received at least one cycle of azacitidine therapy
• \[For both Phase 1 and 2 parts\]
• Patients with a peripheral white blood cell count of ≦12,000/mm3 within 4 weeks (28 days) before enrollment (on the basis of the most recent data during the period if multiple data are available)
• Patients aged ≧20 years at the time of informed consent
• Patients who have provided written voluntary consent in person to participate in this study after fully receiving and understanding the information about this study, including study objectives, contents, expected pharmacological actions and effects, and foreseeable risks
• Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at enrollment
• Patients with a life expectancy of ≧ 3 months (90 days)
• Patients for whom no standard therapies are currently available, including transplant treatments such as allogeneic stem cell transplant

You may not qualify if:

• Patients with a dry tap on bone marrow aspiration before enrollment
• Patients with grade ≧ 3 infection according to the Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE v4.0)
• Patients with a positive test result for HIV antibody, HBs antigen or HCV antibody
• Patients with any intracranial metastasis that is symptomatic or requires treatment
• Patients with active multiple cancers (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ≦ 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other such carcinomas curatively treated with local therapy)
• Patients who had myocardial infarction within 6 months (180 days) before enrollment
• Patients with significant diseases at enrollment that may affect study treatment, such as New York Heart Association (NYHA) Functional Class III or IV heart disease, CTCAE v4.0 grade ≧ 3 arrhythmia, angina pectoris, abnormal electrocardiogram findings, interstitial pneumonia or pulmonary fibrosis
• Patients with uncontrollable complications
• Patients with CTCAE v4.0 grade ≧2 hemorrhage
• Patients who underwent allogeneic hematopoietic stem cell transplant
• Patients who received any of the following treatments within the specified period before enrollment:
• Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks (28 days)
• Immunosuppressants, cytokine preparations (excluding G-CSF): 4 weeks (28 days)
• Endocrine therapy, immunotherapy (including biological response modifier therapy): 2 weeks (14 days)
• Pregnant women or breastfeeding women

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: lead

Study Sites (16)

Japanese Red Cross Narita Hospital

Narita, Chiba, Japan

Location

Chugoku Central Hospital

Fukuyama, Hiroshima, Japan

Location

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, Japan

Location

Kochi Medical School Hospital

Nankoku, Kochi, Japan

Location

Sendai Medical Center

Sendai, Miyagi, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Location

Kindai University Hospital

Sayama, Osaka, Japan

Location

Osaka University Hospital

Suita, Osaka, Japan

Location

Tokyo Metropolitan Geriatric Hospital

Itabashi-ku, Tokyo, Japan

Location

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Japan

Location

Okayama City General Medical Center Okayama City Hospital

Okayama, Japan

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sumitomo Pharma Co., Ltd. Japan

  Sumitomo Pharma Co., Ltd.

  STUDY DIRECTOR

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: April 23, 2015
• First Posted: May 6, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

JP (16)