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Phase 1 Study of ONX 0912 Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors

2014-07-23 21:08:59 | BioPortfolio

Summary

To evaluate the safety and tolerability of ONX 0912 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 ONX 0912 To explore the anti-tumor activity of ONX 0912 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 ONX 0912.

Description

This is a Phase 1, open label, dose-escalation study to determine the safety, MTD, and PK/PDn of ONX 0912 when administered orally (PO) on Days 1, 2, 3, 4, and 5 of a 14 day cycle in patients with advanced refractory or recurrent solid tumor malignancies for which standard curative measures do not exist or are no longer effective.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Solid Tumors

Intervention

ONX 0912

Location

Sarah Cannon Research Institute
Nashville
Tennessee
United States
78229

Status

Recruiting

Source

Onyx Therapeutics, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:59-0400

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