Phase II Trial definition

Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.
Phase II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).
Phase II Trial means a clinical trial of a Licenced Product in human patients, the principal purposes of which are to make a preliminary determination that the Licenced Product is safe for its intended use, to determine its optimal dose, and to obtain sufficient information about the Licenced Product’s efficacy to permit the design of Phase Ill Trials, and consistent with 21 CFR 312.21(b).CONFIDENTIAL

Examples of Phase II Trial in a sentence

  • Phase II Trial of Infusional Cyclophosphamide, Doxorubicin, & Etoposide (CDE) in HIV-Associated Non-Hodgkin's Lymphoma (NHL): an Eastern Cooperative Oncology Group (ECOG) Trial (E1494), Third Anual AIDS Malignancy Conference, Bethesda, May 26 - 27, 1999.8. Kwak LW, Halpern J, Olshen RA, Horning SJ.

  • Section 1.13“Clinical Trial” means any human clinical trial, including a Phase I Trial, a Phase II Trial, a Pivotal Trial, a Phase IV Trial, a Post-Approval-Commitment Trial, an Ongoing IST, a New IST, or a combination of any of the foregoing studies.


More Definitions of Phase II Trial

Phase II Trial means a human clinical trial conducted in any country of the type described in 21 C.F.R. §312.21(b), or an equivalent clinical study required by a regulatory authority outside of the United States.
Phase II Trial means the second phase of a clinical study, the principal purpose of which is to evaluate the effectiveness of the drug for a particular indication and to determine the common short term side effects and risks associated with the drug in patients with the disease target being studied, that provides data capable of meeting statutory standards for marketing approval. Phase II Trials usually involve no more than several hundred subjects. For example, “Phase II Trial” includes a human clinical study that satisfies the requirements of 21 C.F.R. § 312.21(b) in the United States, or an equivalent or counterpart of the foregoing in any other country or jurisdiction. For clarity, “Phase II Trial” includes both Phase IIa and Phase IIb trials.
Phase II Trial means a human clinical trial in any country that is intended to preliminarily evaluate the efficacy and safety of a Licensed Product for a particular indication or indications in patients with the disease or indication under study or would otherwise satisfy requirements of 21 CFR 312.21(b).
Phase II Trial means a human clinical trial that would satisfy the requirements of 21 C.F.R. 312.21(b) (as amended or any replacement thereof), including an equivalent clinical trial conducted in a country other than the United States.
Phase II Trial means a human clinical trial of a Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, as described in 21 C.F.R. 312.21(b), or a similar clinical study prescribed by a Regulatory Authority outside the U.S. For clarity, a Phase II Trial shall not include a Phase I/II Trial. A Phase IIa Trial is a Phase II Trial that is a human clinical trial in not less than 70 patients with the disease or indication under study and that is designed to provide an indication of the efficacy of the Licensed Product for its intended use, and a Phase IIb Trial is a Phase II Trial in patients with the disease or indication under study that is a well-controlled trial designed to be statistically significant.
Phase II Trial means a clinical trial of a Licensed Product in human patients commenced after identifying the maximum tolerated dose, or a lower dose if it is determined to be the optimal dose by TGTX, conducted primarily for the purpose of obtaining sufficient information about the Licensed Product’s safety and efficacy to permit the design of a Phase III Trial.