PIONEER Study definition

PIONEER Study means the multinational, randomized clinical trial (PGT305), with approximately 600 PS2 chemotherapy-naive women with advanced stage NSCLC, pursuant to which (i) each study arm of approximately 300 patients will be randomized to receive either the Product or paclitaxel once every three weeks, and (ii) the primary endpoint is superior overall survival with several secondary endpoints including disease control, response rate in patients with measurable disease, time to disease progression, and disease-related symptoms.
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Examples of PIONEER Study in a sentence

  • Such disclosure shall include all Licensor Know-How pertaining to the manufacture and Development of the Compound and/or Product, including manufacturing batch records, Development reports (including all interim reports and data regarding the PIONEER Study), analytical results, raw material and excipient sourcing information, quality audit findings and any other relevant technical information.

Related to PIONEER Study

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.