Clinical Trials /

A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma

NCT01723020

Description:

First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Multiple Myeloma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study Evaluating AMG 232 in Advanced Solid Tumors or Multiple Myeloma
  • Official Title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors or Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: 20120106
  • NCT ID: NCT01723020

Conditions

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
  • Glioblastoma
  • Multiple Myeloma

Interventions

DrugSynonymsArms
AMG 232AMG 232

Purpose

First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

Detailed Description

      Study Design: This is an open-label, dose exploration study evaluating AMG 232 in subjects
      with advanced p53WT solid tumors or multiple myeloma. The study will be conducted in 2 parts:
      Part 1 - Dose Exploration (parts 1a, 1b and 1c) and Part 2 - Dose Expansion. Part 1a is aimed
      at evaluating the safety, tolerability, PK and PD of AMG 232 and determining the MTD of a
      7-day once daily (QD) dosing schedule in subjects with advanced solid tumors using a
      practical continuous reassessment method (CRM). Part 1b will evaluate the safety and
      tolerability of 3-day QD dosing schedule (or alternate dosing schedule based upon emerging
      data) with a particular emphasis on evaluating the tolerability of daily doses equal to or
      higher than the part 1a MTD in subjects with solid tumors or multiple myeloma. Part 1c will
      evaluate the safety and tolerability of 7-day twice daily (BID) dosing schedule with daily
      cumulative doses equal to or higher than the part 1a MTD in subjects with solid tumors. The
      dose expansion part of the study (Part 2) can open once the MTD has been determined in Part
      1a. Part 2, part 1b and part 1c can be explored in parallel. The dose expansion part will
      consist of up to 85 additional subjects with specific tumors harboring MDM2 amplification
      (liposarcoma [LPS], gliobastoma [ GBM ] and all other solid tumors) or potentially harboring
      MDM2 overexpression (ER+ metastatic breast cancer) and a group of subjects with multiple
      myeloma.
    

Trial Arms

NameTypeDescriptionInterventions
AMG 232ExperimentalAMG 232 is an anti-cancer agent.
  • AMG 232

Eligibility Criteria

        Inclusion Criteria:

          -  Men or women > 18 years old

          -  Pathologically documented, definitively diagnosed, advanced solid tumor that is
             refractory to standard treatment, or which no standard therapy is available, or the
             subject refuses standard therapy or multiple myeloma

          -  Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for
             subjects with multiple myeloma.

          -  Ability to take oral medications and willing to record daily adherance to
             investigational product

          -  Adequate hematological, renal, hepatic, and coagulation laboratory assessments

        Exclusion Criteria:

          -  Active brain metastases

          -  For solid tumor-History or presence of hematological malignancies unless curatively
             treated with no evidence of disease for greater than or equal to 5 years

          -  Active infection requiring intravenous (IV) antibiotics

          -  Anti-tumor therapy

          -  Therapeutic or palliative radiation therapy within 30 days of starting treatment

          -  Currently enrolled in another investigational device or drug study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety
Time Frame:36 months
Safety Issue:
Description:Subject incidence of adverse events, dose limiting toxicities, and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests

Secondary Outcome Measures

Measure:Objective Tumor Response
Time Frame:36 months
Safety Issue:
Description:Duration of overall response and duration of stable disease measured by CT or MRI and assessed per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, for multiple myeloma using IMWG response criteria

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Amgen

Trial Keywords

  • Solid Tumors
  • Multiple Myeloma

Last Updated

December 13, 2017