NCT01723020

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_1

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 27, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2017

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

4.2 years

First QC Date

November 5, 2012

Last Update Submit

August 30, 2021

Conditions

Advanced MalignancyAdvanced Solid TumorsCancerOncologyOncology PatientsTumorsGlioblastomaMultiple Myeloma

Keywords

Solid TumorsMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Safety of AMG 232

    Subject incidence of adverse events, dose limiting toxicities, and clinically significant changes in vital signs, weight, ECGs and clinical laboratory tests

    36 months

Secondary Outcomes (1)

  • Objective Tumor Response

    36 months

Study Arms (1)

AMG 232

EXPERIMENTAL

AMG 232 is an anti-cancer agent.

Drug: AMG 232

Interventions

AMG 232DRUG

Given an an oral tablet in escalating doses.

AMG 232

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Santa Monica, California, 90403, United States

Location

Research Site

Norwalk, Connecticut, 06856, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Hackensack, New Jersey, 07601, United States

Location

Research Site

New Brunswick, New Jersey, 08901, United States

Location

Research Site

New York, New York, 10021, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Research Site

Greenville, South Carolina, 29605, United States

Location

Research Site

Lyon, 69373, France

Location

Research Site

Villejuif, 94805, France

Location

Research Site

Amsterdam, 1066 CX, Netherlands

Location

Research Site

Rotterdam, 3015 CE, Netherlands

Location

Research Site

Utrecht, 3584 CX, Netherlands

Location

Related Links

MeSH Terms

Conditions

NeoplasmsGlioblastomaMultiple Myeloma

Interventions

2-(5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-(1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

December 27, 2012

Primary Completion

March 15, 2017

Study Completion

September 25, 2017

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

NL(3)US(9)FR(2)