PRA to conduct Ph Ib/II clinical trial of PLK1 inhibitor

By Melissa Fassbender

- Last updated on GMT

(Image: iStock/BrianAJackson)
(Image: iStock/BrianAJackson)
Trovagene, Inc. has contracted PRA Health Sciences to conduct its Phase Ib/II clinical trial of PCM-075 in patients with acute myeloid leukemia (AML).

According to the company, PRA will support clinical site recruitment, clinical operations and regulatory proceedings for the development of PCM-075, a polo-like kinase 1 (PLK1) inhibitor.

The Raleigh, NC-based contract research organization (CRO) will assess safety, tolerability, dose and scheduling, and preliminary efficacy of PCM-075 in the Phase Ib/II clinical trial.

Trovagene has filed an Investigational New Drug (IND) application and protocol for PCM-075 to the US Food and Drug Administration (FDA).

The drug previously demonstrated an acceptable safety profile in a Phase I study in patients with advanced metastatic solid tumor cancers.

Related news

Show more

Related products

show more

Reliability, scale, and security of supply

Reliability, scale, and security of supply

Content provided by Univar Solutions USA | 28-Aug-2024 | Product Brochure

Univar Solutions Pharmaceutical Ingredients is proud to offer one of the most expansive portfolios of 15,000+ products, including high-purity solvents,...

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Related suppliers

Follow us

Products

View more

Webinars