- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00511082
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
July 1, 2008 updated by: Otsuka Beijing Research Institute
- To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple Myeloma(MM)
- To determine the potential dose-limiting toxicities and maximum-tolerated dose in patients treated with OPB-31121
- To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The study is designed as a single-center,open-label,phase 1 dose-escalation study to assess the safety,tolerability,pharmacokinetics, and anti-tumor efficacy of OPB-31121 in patients with relapsed or refractory NHL or MM.
- To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients NHL or MM
- To determine the potential dose-limiting toxicities and maximum-tolerated dose in patients treated with OPB-31121
- To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shii Man, M.D & Ph.D.
- Phone Number: 8001 +86-10-85182966
- Email: mans@obri.otsuka.com
Study Locations
-
-
Hong Kong, SAR
-
Shatin, N.T., Hong Kong, SAR, Hong Kong
- Recruiting
- Department of Clinical Oncology, Prince of Wales Hospital
-
Contact:
- Kenny IK Lei, M.D
- Phone Number: (852) 2632 2137
- Email: kennylei@cuhk.cuhk.edu.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have relapsed or refractory NHL histologically confirmed.
- Relapsed or refractory NHL or MM patients must have experienced treatment failure.
- Chinese patients aged 18 years or older at the time of giving informed consent.
- Performance status score of 0-2 according to the incriteria of he Eastern Cooperative Oncology Group(ECOG)
- Life expectancy of longer than 3 months.
- Patients must have adequate vital organ function.
- Patients are willing to comply with the visit schedules of the hospitalization and outpatient clinic.
- Patients with prior chemotherapy, immunotherapy, cytokines therapy, major surgery, and radiotherapy to the index lesion must have been completed for a minimum period of 4 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
- Patients with systemic corticosteroid therapy (>10 mg prednisone or equivalent) must have been completed for a minimum of 1 weeks and recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
- Patients with prior stem cell transplantation must be at least 8 weeks and have recovered from the related toxicity (NCI CTCAE grade 0 or 1) before registration.
Exclusion Criteria:
- Patients are receiving another investigational agent or who have received another investigational agent within 6 months.
- Patients are receiving concurrent chemotherapy, biologic agents, or radiotherapy.
- Patients are receiving concurrent administration of warfarin.
- NHL or MM patients who are candidates for autologous stem cell transplantation are excluded from the study.
- Patients with other primary malignancy except squamous or basal cell skin cancer or cervical cancer in situ.
- Patients with acute lymphoblastic lymphoma/leukaemia, POEMS syndrome or plasma cell leukaemia.
- Lymphoma patients with symptomatic CNS involvement.
- Patients with uncontrolled intercurrent illness.
- Known HIV-positive/AIDS patients.
- Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period.
- Patients will not or are unable to use appropriate contraceptive methods during the study period and for at least 6 months after completion of the study
Patients need to receive any of the following treatments or therapeutic agents during the study period:
- Anti-cancer drugs other than the study drug
- Systemic corticosteroid therapy (>10 mg prednisone or equivalent)
- Radiotherapy as primary therapy
- Immunotherapy
- Surgical therapy
- CYP3A4 and CYP2C9 enzyme inducers or inhibitors,or substrates, and CYP2B6, CYP2C8, and CYP2D6 substrates.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
|
Patients will receive OPB-31121 administered orally, once daily for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kenny IK Lei, M.D, Department of Clinical Oncology, Prince of Wales Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Anticipated)
September 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
August 2, 2007
First Submitted That Met QC Criteria
August 2, 2007
First Posted (Estimate)
August 3, 2007
Study Record Updates
Last Update Posted (Estimate)
July 2, 2008
Last Update Submitted That Met QC Criteria
July 1, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Lymphoma, Non-Hodgkin
Other Study ID Numbers
- 252-07-801-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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