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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: Completed Phase 1 study of Solid Tumors, sponsored by Amgen.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

* 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

Conditions Studied

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
Amgen

558 total trials

What the finished NCT01129349 record still lists

NCT01129349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (85% lower).

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 a single indexed study location in 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.

Similar trials for Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01129349's enrollment target sits among peer trials

44 89th of 125 higher than 36 of 125 other Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01129349, the US trial registry maintained by the National Library of Medicine. NCT01129349 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.