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PX-866 is an oral, irreversible, pan-isoform inhibitor of the PI-3-kinase/PTEN/AKT signaling pathway that is implicated in many types of human cancers including breast, glioma, colon, ovarian, prostate, melanoma, lung, and head and neck cancers. Aberrant activation and regulation of PI-3-kinase leads to increased cell proliferation and inhibition of apoptosis (programmed cell death). PX-866 has been shown to induce prolonged inhibition of tumor PI-3-kinase signaling, and has demonstrated anti-tumor activity both as a single agent and in combination with other agents in a number of human tumor models. PX-866 is currently in being evaluated in Phase 1/2 and Phase 2 clinical trials.
For detailed information on ongoing clinical trials listed below, including inclusion criteria and participating centers, please click on study titles or links below to be directed to respective listings on clinicaltrials.gov.
PX-866 Clinical Trials Now Enrolling
Phase 1 / 2 Trial of PX-866 and Docetaxel in Patients with Solid Tumors »
A multicenter, open label, Phase 1 / 2 trial evaluating PX-866 in combination with docetaxel (Taxotere®) in patients with locally advanced, recurrent or metastatic cancer. The Phase 1 component is designed to determine the maximum tolerated or recommended dose of PX-866 that can be given with docetaxel. The Phase 2 portion of the trial is an open-label, randomized evaluation of the antitumor activity and safety of PX-866 administered at the recommended daily dose in combination with docetaxel, versus docetaxel alone, in two groups of patients. Group 1 will enroll patients with non-small lung cancer receiving second or third line treatment. Group 2 will enroll patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck after failure of prior therapy. The two groups will be randomized and evaluated independently.
The Phase 1 portion of this study has been completed, and the Phase 2 portion of this study is now enrolling.
Find more information about this trial on Clinicaltrials.gov.
Phase 1 / 2 Trial of PX-866 + Cetuximab in Patients with Colorectal Cancer and Squamous Cell Carcinoma of the Head and Neck »
A multicenter, open label Phase 1 / 2 trial evaluating PX-866 in combination with cetuximab (Erbitux®) patients with either progressive metastatic colorectal carcinoma (CRC) or progressive, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The primary objective of the Phase 1 dose-escalation portion of the trial is to determine the maximum tolerated or recommended daily dose of PX-866 to be given in combination with the standard dose of cetuximab administered weekly to patients. The Phase 2 portion is designed as a screening trial and will be an open-label, randomized evaluation of the antitumor activity and safety of PX-866 administered at the maximum tolerated or recommended dose from Phase 1 in combination with cetuximab, versus cetuximab alone, in two groups of patients not previously treated with cetuximab. Group 1 will enroll patients with metastatic CRC who have a history of progression or recurrence following prior treatment with irinotecan and oxaliplatin containing regimens or who are intolerant of irinotecan. Patients with CRC and Kras mutations are excluded from the trial. Group 2 will enroll patients with progressive, recurrent or metastatic SCCHN. The two groups will be randomized and evaluated independently.
The Phase 1 portion of this study has been completed, and the Phase 2 portion of this study is now enrolling.
Enrolling in this Clinical Trial - More information about this clinical trial can be found on CenterWatch. Information on this trial is also available at Clinicaltrials.gov.
Phase 2 Trial of PX-866 in Patients with Glioblastoma Multiforme »
An open label, Phase 2 trial evaluating PX-866 in patients with glioblastoma multiforme that has recurred during or following primary therapy is currently underway.
The primary objective of this single-arm screening trial is a combination of objective response rate and early progression. The trial will enroll up to 30 patients whose brain tumor is in first relapse during or following primary therapy. The trial is being conducted at 7 Canadian centers by the NCIC Clinical Trials Group (NCIC CTG), Queen's University in Kingston, Canada.
Find more information about this trial on Clinicaltrials.gov.
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