Clinical trial NCT00511082: Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Official title: Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma(NHL)
Multiple Myeloma
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-08-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 4 weeks
Secondary outcomes:
measure: 1.Pharmacokinetic Endpoints 2.Efficacy Endpoints & Response Criteria
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital
Study officials:
affiliation: Department of Clinical Oncology, Prince of Wales Hospital
name: Kenny IK Lei, M.D
role: PRINCIPAL_INVESTIGATOR
References: