A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
The purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced solid tumors
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors|
- Dose Limiting Toxicity [ Time Frame: up to 3 weeks of OTX008 treatment ] [ Designated as safety issue: Yes ]Dose Limiting Toxicity (DLT) will be assessed during the first 21 days (3 weeks)of OTX008 treatment in each patient to determine Recommended Dose (RD)
- Pharmacokinetics (PK) [ Time Frame: Days 1, 2 and 22 of OTX008 treatment ] [ Designated as safety issue: No ]OTX008 plasma concentration will be assessed at days 1, 2 and 22 of OTX008 treatment to determine PK profile of OTX008. Following parameters will be used: Trough (Cmin) and peak (Cmax) of OTX008 concentrations, Tmax, t1/2, steady state, total clearance, AUC (Area Under Curve)
- Pharmacodynamics (PD) [ Time Frame: Days 1 and 22 of OTX008 treatment ] [ Designated as safety issue: No ]Following parameter will be measured: plasma levels of galectin-1
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day.
OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day
Overexpression of galectin-1 protein is well documented in different types of cancers, with associated bad prognostic and enhanced metastases spreading.
In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and it was observed a blood vessels architecture normalization.
Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
|Contact: Patrice HERAIT, MD||+33 6 85 12 ext 00 firstname.lastname@example.org|
|Institut Jules Bordet||Recruiting|
|Brussels, Belgium, 1000|
|Contact: Ahmad AWADA, MD +32 2 541 ext 31 89 email@example.com|
|Principal Investigator: Ahmad AWADA, MD|
|Hopital Beaujon - AP-HP||Recruiting|
|Clichy, France, 92110|
|Contact: Eric RAYMOND, MD +33 1 40 87 ext 56 17 firstname.lastname@example.org|
|Principal Investigator: Eric RAYMOND, MD|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Jean-Pierre DELORD, MD +33 5 67 22 ext 25 67 email@example.com|
|Principal Investigator: Jean-Pierre DELORD, MD|