臨床研究等提出・公開システム

Date of registration	July. 17, 2018
Last modified on	Oct. 14, 2020
Trial ID	jRCT2080223979

Scientific Title	A multicenter, open-label, non-controlled, dose-escalation study in patients with relapsed/refractory multiple myeloma and non-Hodgkin's lymphoma (ONO-7705-01)
Public Title	ONO-7705 Phase I study (ONO-7705-01)

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address
	Phone Number
	E-mail Address	k.takehara@ono.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address
	Phone Number	+81-120-626-190（受付時間：土・日・祝日を除く9:00−17:00）
	E-mail Address	clinical_trial@ono.co.jp

Recruitment Status	completed

Date of First Enrolment		Oct. 01, 2018
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	multicenter, open-label, non-controlled, dose-escalation study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who are able to stay in hospital from a day before starting the study drug of the first course until the end of the relevant tests on Day 28 2. Patients with relapsed/refractory MM or NHL 3. Patients who have received two or more lines of therapies for MM or NHL
	Exclusion Criteria	1. Patients with plasma cell leukemia (defined as a peripheral blood plasma cell count > 2.0*10^9/L by the standard classification method) 2. Patients with primary amyloidosis 3. Patients with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes) 4. Patients with acute lymphocytic leukemia 5. Patients with lymphoblastic lymphoma 6. Patients with Burkitt's lymphoma or Richter's Syndrome
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		MM and NHL
Intervention(s)		investigational material(s) Generic name etc : Selinexor(ONO-7705) INN of investigational material : Selinexor Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : oral administration control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety tolerability of ONO-7705 in relapsed/refractory MM and NHL patients
Secondary Outcome		safety efficacy pharmacokinetics pharmacodynamics pharmacokinetics, pharmacodynamics, safety and efficacy of ONO-7705 in relapsed/refractory MM and NHL patients

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Japanese Red Cross Medical Center Institutional review board
Address of IRB	4-1-22 Hiroo,shibuya-ku,Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 17, 2018

Secondary ID No.	JapicCTI-184037
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	Oct. 14, 2020	(this page)	Changes
7	July. 06, 2020	Detail	Changes
6	Sept. 05, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Oct. 01, 2018	Detail	Changes
3	Oct. 01, 2018	Detail	Changes
2	July. 17, 2018	Detail	Changes
1	July. 17, 2018	Detail

List of change history