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Trial record 2 of 47 for:    intrepid

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma (INTREPID-1)

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ClinicalTrials.gov Identifier: NCT02939183
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: Immediate Release (IR) Formulation Drug: Gastro-Retentive (GR) Formulation Drug: Dexamethasone Drug: Pomalidomide Phase 1

Detailed Description:
A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: (INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : April 29, 2020
Estimated Study Completion Date : April 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Part 1 Arm 1
Oprozomib (Immediate Release) plus dexamethasone
Drug: Immediate Release (IR) Formulation
Immediate Release (IR) Formulation

Drug: Dexamethasone
Dexamethasone

Experimental: Part 1 Arm 2
Oprozomib (Gastro-retentive) plus dexamethasone
Drug: Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation

Drug: Dexamethasone
Dexamethasone

Experimental: Part 2 Arm 1
Oprozomib (Immediate release) plus pomalidomide and dexamethasone
Drug: Immediate Release (IR) Formulation
Immediate Release (IR) Formulation

Drug: Dexamethasone
Dexamethasone

Drug: Pomalidomide
Pomalidomide

Experimental: Part 2 Arm 2
Oprozomib (Gastro-retentive) plus pomalidomide and dexamethasone
Drug: Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation

Drug: Dexamethasone
Dexamethasone

Drug: Pomalidomide
Pomalidomide




Primary Outcome Measures :
  1. Determine the maximum tolerated dose for each formulation of oprozomib in combination with pomalidomide and dexamethasone [ Time Frame: The primary analysis will be based on subject data collected up to 2 months from the date of last subject enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Subject must have a pathologically documented, definitively diagnosed, multiple myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalidomide.
  • Subject must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
  • Measurable disease (assessed within 28 days prior to day 1)
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
  • Other Inclusion Criteria May Apply

Exclusion Criteria

  • Currently receiving treatment in another investigational device or drug study, or less than 28 days or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s).
  • Previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1;received immunosuppressive therapy within the last 3 months prior to study day 1;having signs or symptoms of acute or chronic graft-versus-host disease.
  • Autologous stem cell transplant < 90 days prior to study day 1.
  • Multiple myeloma with IgM subtype.
  • POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
  • Waldenstrom's macroglobulinemia.
  • Other Exclusion Criteria May Apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939183


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, California
Research Site Recruiting
West Hollywood, California, United States, 90069
United States, Florida
Research Site Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Site Recruiting
Chicago, Illinois, United States, 60637-6613
United States, Maryland
Research Site Recruiting
Bethesda, Maryland, United States, 20817
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Research Site Recruiting
New York, New York, United States, 10021
United States, North Carolina
Research Site Recruiting
Charlotte, North Carolina, United States, 28204
United States, Wisconsin
Research Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, Victoria
Research Site Recruiting
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Research Site Recruiting
Murdoch, Western Australia, Australia, 6150
Research Site Recruiting
Nedlands, Western Australia, Australia, 6009
Belgium
Research Site Recruiting
Gent, Belgium, 9000
Canada, Alberta
Research Site Recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Research Site Recruiting
Toronto, Ontario, Canada, M5G 2C1
Netherlands
Research Site Recruiting
Rotterdam, Netherlands, 3015 CE
Spain
Research Site Recruiting
Salamanca, Castilla León, Spain, 37007
Research Site Recruiting
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02939183     History of Changes
Other Study ID Numbers: 20160104
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Keywords provided by Amgen:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Pomalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents