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 in patients with acute leukemia.

The first clinical trial with PR610 is scheduled to start in early 2012.

For additional information on individual clinical trials, please follow the appropriate link below.

Open Trials

PR104-2004: Phase I/II Study of PR104 in Subjects With Refractory/Relapsed Acute Leukemia (AML/ALL) Using Adaptive Dose Selection
This study is designed to evaluate the activity and toxicity of PR104 in people with refractory/relapsed Acute Leukemia (AML/ALL), and to determine an optimal individualized dose for each patient based on key covariates (prior CR duration, prior number of salvage therapies, age). This information will help guide future clinical development of PR104, and will determine if PR104 has sufficient activity and safety in AML or ALL to warrant future clinical studies. The study is being conducted at sites in Texas and Washington.

Closed Trials

PR104-1001: A Phase I, Multi-Center, Open Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given Every 3 Weeks in Patients with Solid Tumors

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

PR104-1003: A Phase Ib, Multi-Center, Open Label, Dose Escalation Trial of Intravenous PR104 Given in Combination with Docetaxel or Gemcitabine in Subjects with Solid Tumors

PR104-1004: A Phase Ib, Multi-Center, Open Label, Dose Escalation Trial of Intravenous PR104 Given in Combination with GCSF in Subjects with Solid Tumors

PR104-2001: A Phase II, Multi-Center, Open-Label, Trial of PR104 in Treatment Naive and Sensitive-relapse Small Cell Lung Cancer

PR104-2002: A Phase I/II Randomized Phase Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

PR104-2003: A Phase II Randomized, Multi-Center, Open-Label, Study of Docetaxel Versus Docetaxel/PR104 in Non-Small Cell Lung Cancer (NSCLC)
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