Status: Closed
Activation Date: 2015AUG24
Closing Date: 2017APR20
Phase: I
Description: A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies
Eligibility: Patients with histologically and/or cytologically confirmed high-grade serous ovarian/fallopian tube or peritoneal carcinoma. Patients must have received prior cytotoxic chemotherapy (at least one regimen must have been platinum-containing) and may be either platinum sensitive or platinum resistant. Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. For Part 2, must be willing to undergo a tumour biopsy prior to registration. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active immune-mediated diseases including known HIV infection or hepatitis B/C. No systemic corticosteroid therapy at doses higher than 5 mg/day.
Objective: PRIMARY - To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin. SECONDARY - (1) To characterize the pharmacokinetics of IPH2201 when administered as a single agent; (2) To assess the pharmacodynamic effects of single agent IPH2201; (3) To assess the safety and toxicity profile of single agent IPH2201; (4) To explore the efficacy of IPH2201 in platinum resistant or sensitive HGSC; (5) To characterize the immunogenicity of IPH2201 when administered as a single agent.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to determine the best dose of IPH2201 in patients with high-grade serous ovarian/fallopian tube or peritoneal carcinoma (platinum sensitive or platinum resistant), and to investigate the safety and toxicity of IPH2201. Additional research will investigate how IPH2201 is absorbed, how long IPH2201 stays in the body, and what effects IPH2201 is having on the cancer cells.
Primary Publication Show
Other Publications Show
Inventory
Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I221 | 59 | 56 | 40 | 58 |
(Core size is 0.6 mm)
Hide
Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I221 | 59 | 1 | 2 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I221 | 59 | 53 | 0 | 0 | 0 | 53 | 54 | 0 | 0 |