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Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

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Otsuka

Status and phase

Unknown
Phase 1

Conditions

Non-Hodgkin's Lymphoma(NHL)
Multiple Myeloma(MM)

Treatments

Drug: OPB-31121

Study type

Interventional

Funder types

Industry

Identifiers

NCT00511082
252-07-801-01

Details and patient eligibility

About

  • 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

Full 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

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

Treatment group
Experimental group
Treatment:
Drug: OPB-31121

Trial contacts and locations

1

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Central trial contact

Shii Man, M.D & Ph.D.

Data sourced from clinicaltrials.gov

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