A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
|Official Title:||A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies|
- Dose of single agent IPH2201 for phase II studies and determined based on toxicity, as well as pharmacokinetic and pharmacodynamics data [ Time Frame: 24 months ]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.
- Number and severity of adverse events in patients [ Time Frame: 24 months ]• Safety and tolerability of IPH2201
- Correlative assays evaluation for potential predictive markers of IPH2201 effects. Concentration at the end of administration (Cinf end) for all patients [ Time Frame: 24 months ]Correlative assays will be used to evaluate potential predictive markers of IPH2201 effects. Other potential prognostic or predictive molecular factors will be assesses in archival tumour tissue, CTCs and blood samples.
- Area under the curve from time 0 to Tau=2 weeks (AUC(0-Tau) [ Time Frame: 24 months ]
- Accumulation ratio, in terms of Cmax and AUC(0-Tau), between C1 and C4 [ Time Frame: 24 months ]
|Actual Study Start Date:||August 24, 2015|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Part 1: 1, 4 or 10mg/kg, IV, 1 hour duration on Day 1 every 2 weeks.
Part 2: Patients will receive single agent IPH2201 as above with the actual dose dependent on the outcome of Part 1
This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy may cause this cancer to shrink for a time, better options are needed. In laboratory tests and animals, IPH2201 has been shown to have effects which result in shrinkage of tumours. IPH2201 has been studied in people with rheumatoid arthritis but it has not yet been studied in people with cancer and the investigators do not know if it can offer better results than standard treatment.
The standard or usual treatment for this disease could include surgery, chemotherapy or radiation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02459301
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 5W9|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|Study Chair:||Hal Hirte||Juravinski Cancer Centre at Hamilton Health Sciences, ON Canada|
|Study Chair:||Anna Tinker||BCCA - Vancouver Cancer Centre, BC Canada|