Topics

Study of ORIC-101 in Combination With Anticancer Therapy in Patients With Solid Tumors

2019-05-01 16:42:35 | BioPortfolio

Summary

The purpose of this study is to establish the recommended Phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combination with other anticancer therapies when administered to patients with advanced or metastatic solid tumors.

Description

ORIC-101 is a small molecule GR antagonist being developed for the treatment of patients with solid tumor malignancies. Mechanistically, ORIC-101 inhibits GR transcriptional activity and blocks the pro-survival signals mediated by the activated nuclear receptor.

This is an open-label, uncontrolled, multicenter, dose-finding study to assess the safety and preliminary antitumor activity of ORIC-101 in combination with anticancer therapy in patients with advanced or metastatic solid tumors. The study will begin with dose finding in combination initially with nab-paclitaxel; additional dose-finding cohorts with other anticancer therapies may be evaluated through protocol amendment(s).

The study will first evaluate intermittent administration (5 days on, 2 days off for 21 days) of ORIC-101 followed by continuous administration (daily for 21 days) in combination with nab-paclitaxel using a standard 3+3 dose escalation design.

Dose expansion may further evaluate the safety of ORIC-101 at a dose selected from dose escalation.

Study Design

Conditions

Solid Tumor

Intervention

ORIC-101, Nab-paclitaxel

Location

Stanford Cancer Institute
Palo Alto
California
United States
94304

Status

Not yet recruiting

Source

Oric Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-05-01T16:42:35-0400

Clinical Trials [3602 Associated Clinical Trials listed on BioPortfolio]

Study of ORIC-101 in Healthy Adult Subjects

ORIC-GR-17001 is an open-label, single center, non-randomized, single ascending dose study in healthy male subjects and healthy female subjects of non-child bearing potential. In this stud...

Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with ABI-0...

Study of ORIC-101 in Combination With Enzalutamide

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-101 in combi...

17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor

RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die...

Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects

This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral...

PubMed Articles [8917 Associated PubMed Articles listed on BioPortfolio]

Enhancing intratumoral biodistribution and antitumor activity of nab-paclitaxel through combination with a vascular disrupting agent, combretastatin A-4-phosphate.

Nanomedicines can generally only reach cancer cells at the edges of tumors, leaving most tumor cells in the central regions untreated. Previous studies showed that treatment with the vascular disrupti...

The role of Helicobacter pylori DnaA domain I in orisome assembly on a bipartite origin of chromosome replication.

The main roles of the DnaA protein are to bind the origin of chromosome replication (oriC), to unwind DNA and to provide a hub for the step-wise assembly of a replisome. DnaA is composed of four domai...

The programmed site-specific delivery of the angiostatin sunitinib and chemotherapeutic paclitaxel for highly efficient tumor treatment.

Malignant solid tumors are composed of tumor cells, stromal cells and the complex networks of the tumor microenvironment (TME), which is the underlying cause of the unsatisfactory outcome of conventio...

Cellular Interactome Dynamics during Paclitaxel Treatment.

Cell-cycle inhibitors, including paclitaxel, are among the most widely used and effective cancer therapies. However, several challenges limit the success of paclitaxel, including drug resistance and t...

Does nab-paclitaxel have a higher incidence of peripheral neuropathy than solvent-based paclitaxel? Evidence from a systematic review and meta-analysis.

Paclitaxel-induced peripheral neuropathy is a common reason for dose reduction or early cessation of therapy. Nab-paclitaxel was developed to provide additional clinical benefits and overcome the safe...

Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)

A solid tumor consisting of a dense infiltration of MAST CELLS. It is generally benign.

An adenocarcinoma in which the tumor elements are arranged as finger-like processes or as a solid spherical nodule projecting from an epithelial surface.

More From BioPortfolio on "Study of ORIC-101 in Combination With Anticancer Therapy in Patients With Solid Tumors"

Quick Search

Relevant Topics

Cancer Disease
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...

BioPortfolio - life science, medical devices and pharmaceutical conference
BioPortfolio is a leading news, information and knowledge resource covering the global life science industries impacted on by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to so...


Searches Linking to this Trial