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NCT01129349 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study of Oprozomib Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors

A Phase 1 study of Solid Tumors, sponsored by Amgen.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target
3
Study locations

NCT01129349 is a Phase 1 study of Solid Tumors that has completed, run by Amgen. The registered enrollment target is 44 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT01129349, a Phase 1 study of Solid Tumors, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target
3
Study locations

Study Summary

To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore the anti-tumor activity of Oprozomib in this patient population including the overall response rate (ORR), the duration of responses (DOR), the progression-free survival (PFS) and time to progression (TTP) To define the pharmacodynamics (PDn) of Oprozomib.

Conditions Studied

Solid Tumors

Interventions

  • DRUG Oprozomib

Study Locations (3)

Arizona

  • Oncology Research Associates - Scottsdale

Tennessee

  • Sarah Cannon Research Institute - Nashville

Texas

  • South Texas Accelerated Research Therapeutics - San Antonio

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2010-04
Est. Completion 2013-03
Phase Phase 1

Sponsor

Amgen

558 total trials

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What the Registry Record Tells You About NCT01129349

The ClinicalTrials.gov registry entry for NCT01129349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (85% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Oprozomib is the first listed.

NCT01129349 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Tennessee, Texas.

Frequently Asked Questions

What is clinical trial NCT01129349 about?

NCT01129349 is a clinical study titled "Phase 1 Study of Oprozomib Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors". To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore the anti-tumor activity of O...

What is the current status of trial NCT01129349?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-04. Estimated completion is 2013-03.

What conditions does trial NCT01129349 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT01129349?

The interventions under investigation include: Oprozomib (DRUG).

Who is sponsoring clinical trial NCT01129349?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01129349 being conducted?

This trial has 3 study locations across Arizona, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.