Clinical Trials
Clinical Trials
Clinical trials are designed to test the safety and/or effectiveness of new drugs in humans. A series of clinical trials must be completed before a drug can be approved for use. Proacta is currently conducting a Phase I/II clinical trial with its lead compound, PR104. The first clinical trial with its second compound, PR509, should start in 2011.
For additional information on individual clinical trials, please follow the appropriate link below.
Open Trials
This study is designed to provide estimates of the activity and toxicity of PR104 in people with refractory/relapsed AML, and to determine an optimal individualized dose to give each person based on key covariates (prior CR duration, prior number of salvage therapies, age). This information will help determine the future clinical development of PR104, and in determining if PR104 has sufficient activity and safety in AML to warrant future clinical studies in this indication. The study is being conducted at sites in Texas and Washington.
Closed Trials
This study was designed to find the correct dose of PR104 when it is given once every three weeks to people with various types of cancer. The study also helped determine the type of side effects that are expected with PR104 when given once every three weeks. This study was initiated in 2006 at clinical sites in the US, New Zealand, and Australia, and has now been completed.
PR104-1002: A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given Weekly in Subjects with Solid Tumors
This study was designed to find the correct dose of PR104 when given once each week to people with various types of cancer. The study also helped determine the type of side effects that can be expected with PR104 when given weekly. The study was conducted in the US and New Zealand.
This study was designed to find the correct dose of PR104 when it is given once every three weeks to people with various types of cancer. The study also helped determine the type of side effects that are expected with PR104 when given once every three weeks. This study was initiated in 2006 at clinical sites in the US, New Zealand, and Australia, and has now been completed.
This study tested the ability of GCSF (granulocyte-colony stimulating factor) to protect people against potential neutropenia that can be seen following administration of PR104. The study started in February 2008 and has now been completed.
This study was designed to evaluate PR104 given in combination with sorafenib to people with locally advanced or metastatic Hepatocellular Carcinoma. It was conducted at clinical sites in the United States, Hong Kong, Taiwan and Singapore.
This study was designed to assess the effectiveness of PR104 given in combination with docetaxel to people with recurrent or relapsed, locally advanced or metastatic, Non-Small Cell Lung Cancer. It was conducted at clinical sites in the United States.
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