A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies

Official Title

A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies

Summary:

The purpose of this study is to test the safety of a new drug, IPH2201, to see what effects it has on this type of cancer.

Trial Description

Primary Outcome:

  • Dose of single agent IPH2201 for phase II studies and determined based on toxicity, as well as pharmacokinetic and pharmacodynamics data
Secondary Outcome:
  • Number and severity of adverse events in patients
  • Correlative assays evaluation for potential predictive markers of IPH2201 effects. Concentration at the end of administration (Cinf end) for all patients
  • Area under the curve from time 0 to Tau=2 weeks (AUC(0-Tau)
  • Accumulation ratio, in terms of Cmax and AUC(0-Tau), between C1 and C4
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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society