Overview and Schema Sample Clauses

Overview and Schema. This Phase 3 study is designed to compare the efficacy and safety of MIRV vs. IC Chemo in patients with platinum-resistant high-grade EOC, primary peritoneal, or fallopian tube cancer, whose tumors express a high level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy. FRα expression will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. This study will be opened/active at approximately 200 sites globally. Eligible patients (N = 430), who have provided informed consent and meet study entry criteria will be randomized (1:1) to one of two arms: • Arm 1 (n = 215): MIRV 6 mg/kg AIBW Q3W • Arm 2 (n = 215): IC Chemo, at one of the following regimens as determined by the Investigator prior to randomization: − Paclitaxel (Pac; 80 mg/m2) administered QW − Pegylated liposomal doxorubicin (PLD; 40 mg/m2) administered Q4W − Topotecan (Topo; 4 mg/m2) administered either on Days 1, 8, and 15 every 4 weeks (Q4W) or for 5 consecutive days (1.25 mg/m2 Days 1–5) Q3W Patients will be stratified by the following variable at baseline: • Number of prior lines of therapy (1 vs. 2 vs. 3) • IC Chemo (Pac vs. PLD vs. Topo) chosen prior to randomization Disease progression will be evaluated by the Investigator using RECIST v 1.1 (Appendix B). CT or magnetic resonance imaging (MRI) scans will be collected and held for sensitivity analysis by a BICR. Patients will continue to receive study drug until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 1 week) from C1D1 (for all regimens) for the first 36 weeks then every 12 weeks (± 3 weeks) until disease progression, death, the initiation of subsequent anticancer therapy, or patient’s withdrawal of consent, whichever occurs first. Patients who discontinue study treatment for reasons other than progressive disease (PD) will continue with tumor assessments until documentation of PD or the start of a new anticancer therapy, whichever comes first. Prior to Week 36 (from Cycle 1, Day 1), assessments should occur every 6 weeks (± 1 week) as allowed by local requirements but must occur at an interval of no more than 12 weeks. After Week 36, assessment will occur every 12 weeks (± 3 weeks) until documentation of PD, death, the start of new anticancer therapy or patient...
Sample 1
AutoNDA by SimpleDocs
Overview and Schema. This Phase 3 study is designed to evaluate the efficacy and safety of MIRV in patients with platinum-resistant high-grade serous EOC, primary peritoneal, or fallopian tube cancer, whose tumors express a high level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent- therapy. FRα expression will be defined by the Ventana FOLRI Assay. Approximately 110 patients who have provided informed consent and meet study entry criteria will be enrolled to achieve a total of 105 efficacy evaluable patients. Efficacy evaluable patients include those who have measurable lesions (per RECIST v1.1) at baseline and received at least 1 dose of MIRV. Enrolled patients will receive single-agent MIRV at 6 mg/kg AIBW administered Q3W. Tumor response will be evaluated by the Investigator using RECIST v1.1. CT or MRI scans will be collected for sensitivity analysis by a BICR. Patients will continue to receive MIRV until PD, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first). Tumor assessments, including radiological assessment by CT/MRI scan, will be performed at Screening and subsequently every 6 weeks (± 1 week) from C1D1 for the first 36 weeks then every 12 weeks (± 3 weeks) until PD, death, the start of new anticancer therapy, or patient’s withdrawal of consent, whichever occurs first. Patients who discontinue MIRV for reasons other than progressive disease (PD) will continue with tumor assessments until documentation of PD or the start of a new anticancer therapy, whichever comes first. Prior to Week 36 (from Cycle 1, Day 1), assessments should occur every 6 weeks (± 1 week) as allowed by local requirements but must occur at an interval of no more than 12 weeks. After Week 36, assessment will occur every 12 weeks (± 3 weeks) until documentation of PD or the start of new anticancer therapy. All patients who discontinue study drug will be followed every 3 months (± 1 month) until death, lost to follow-up, withdrawal of consent for survival follow-up, or EOS, whichever comes first. There will be no interim analysis.
Sample 1

Related to Overview and Schema

  • Background Purchaser wishes to purchase a Revenue Sharing Note issued by the Company through xxx.Xxxxxxxx.xxx (the “Site”).

  • General Provisions In connection with any Registration Statement and any Prospectus required by this Agreement to permit the sale or resale of Transfer Restricted Securities (including, without limitation, any Registration Statement and the related Prospectus required to permit resales of Initial Securities by Broker-Dealers), each of the Company and the Guarantors shall:

  • Definitions As used in this Agreement, the following terms shall have the following meanings:

  • Entire Agreement This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter contained in this Agreement and supersedes all prior agreements, understandings and negotiations between the parties.

  • Dispute Resolution All or any disputes arising out or touching upon or in relation to the terms and conditions of this Agreement, including the interpretation and validity of the terms thereof and the respective rights and obligations of the Parties, shall be settled amicably by mutual discussion, failing which the same shall be settled through the adjudicating officer appointed under the Act.

  • GRIEVANCE PROCEDURE 7.01 For purposes of this Agreement, a grievance is defined as a difference arising between the parties relating to the interpretation, application, administration or alleged violation of the Agreement including any question as to whether a matter is arbitrable.

  • Intellectual Property The Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement. Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the SEC Reports, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Headings The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

  • Interpretation In this Agreement, unless the context otherwise requires:

  • Introduction The Texas Health and Human Services Commission ("HHSC") and the Contractor named in Section I (HHSC and Contractor may be referenced in this document collectively as the “Parties” and individually as the “Party") hereby enter into this Community Services Contract - Provider Agreement (the “Contract”) for the provision of services under the Contract type specified in Section I for the considerations set forth herein. The Contract Begin Date specified in Section I is not valid until this Contract is signed by both parties.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!