A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
Recruitment status was Recruiting
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724320
|Contact: Patrice HERAIT, MD||+33 6 85 12 ext 00 email@example.com|
|Institut Jules Bordet||Recruiting|
|Brussels, Belgium, 1000|
|Contact: Ahmad AWADA, MD +32 2 541 ext 31 89 firstname.lastname@example.org|
|Principal Investigator: Ahmad AWADA, MD|
|Hopital Beaujon - AP-HP||Recruiting|
|Clichy, France, 92110|
|Contact: Eric RAYMOND, MD +33 1 40 87 ext 56 17 email@example.com|
|Principal Investigator: Eric RAYMOND, MD|
|Institut Claudius Regaud||Recruiting|
|Toulouse, France, 31052|
|Contact: Jean-Pierre DELORD, MD +33 5 67 22 ext 25 67 firstname.lastname@example.org|
|Principal Investigator: Jean-Pierre DELORD, MD|