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 in the general population.
Proacta is currently conducting Phase 1 and Phase 2 clinical trials with its lead compound, PR104. Clinical trials with its second compound, the HSMKIs, are expected to start in 2010.
For additional information on individual clinical trials, please follow the appropriate link below.
Open Trials
Study PR-104-2004: Phase I/II Study of PR104 in Subjects With Refractory/Relapsed Acute Myelogenous Leukemia Using Adaptive Dose Selection
The current study is designed to provide estimates of the activity and toxicity of PR104 in subjects with refractory/relapsed AML, and determine the optimal individualized dose to give each subject based on his/her covariates (prior CR duration, prior number of salvage therapies, age). This information will prove valuable in defining the future clinical development of PR104, and in determining if PR104 has sufficient activity and acceptable safety in AML to warrant future phase II or phase III studies in this indication.
Closed Trials
Study PR-104-1001: A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Every 3 Weeks in Patients with Solid Tumors.
This study was designed to find the correct dose of PR-104 when it is given once every three weeks to patients with various types of cancer. The study also helped determine the type of side effects that can be expected with PR-104. This study was initiated in 2006 at clinical sites in the US, New Zealand, and Australia, and has now been completed.
PR-104-1002: A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR-104 Given Weekly in Subjects with Solid Tumors.
This study was designed to find the correct dose of PR-104 when given every week to patients with various types of cancer. The study also helped determine the type of side effects that can be expected with PR-104. The study was conducted in the US and New Zealand.
PR-104-1003: A Phase Ib, Multi-Center, Open Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination with Docetaxel or Gemcitabine in Subjects with Solid Tumors
This study was designed to find the correct dose of PR-104 when given along with either docetaxel or with gemcitabine. Both docetaxel and gemcitabine are approved cancer drugs that are used commonly to treat many different types of cancer. The study started in March 2007 and completed in early 2010.
PR-104-1004: A Phase Ib, Multi-Center, Open Label, Dose Escalation Trial of Intravenous PR-104 Given in Combination with G-CSF in Subjects with Solid Tumors
This study uses G-CSF (granulocyte-colony stimulating factor) to protect subjects against potential neutropenia that can develop during administration of PR-104.The study started in February 2008 and has now been completed.
PR104-2002: A Phase I/II Randomized Phase Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
This study was designed to evaluate PR104 given in combination with sorafenib to patients with locally advanced or metastatic Hepatocellular Carcinoma. It was conducted at clinical sites in the United States, Hong Kong, Taiwan and Singapore.
PR104-2003: A Phase II Randomized, Multi-Center, Open-Label, Study of Docetaxel Versus Docetaxel/PR104 in Non-Small Cell Lung Cancer (NSCLC)
This study was designed to assess the effectiveness of PR104 given in combination with docetaxel to patients 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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