A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by OncoEthix
Sponsor:
Information provided by (Responsible Party):
OncoEthix
ClinicalTrials.gov Identifier:
NCT01724320
First received: November 2, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: OTX008
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by OncoEthix:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: OTX008
Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day.
Drug: OTX008
OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to beginning protocol specific screening procedures. Patients registered in this trial must be treated and followed at the participating centers. Patients should receive the study treatment within 7 days after registration
  • Histologically proven malignant solid tumor
  • Patients having failed all standard therapies, or for whom standard therapies are deemed ineffective or contra-indicated.
  • Patients aged > 18 years.
  • ECOG performance status (PS) of 0 to 1
  • Off previous systemic therapy (except LH-RH agonist therapy started > 2 months prior to study entry that could be continued) , radiation therapy, or surgery for at least 30 days prior to first study treatment administration (45 days for bicalutamide).
  • Recovery from the toxic effects of prior treatment to NCIC-CTC grade < 1, except alopecia
  • Adequate bone marrow function including: Neutrophils >= 1.5 x 10E9 /L; platelets >= 100 x 10E9 /L, Hb > 8g/dL without transfusion.
  • Creatinine clearance >= 60 mL/min (Cockroft & Gault formula, or MDRD formula for patients aged > 65 years).
  • Adequate LFTs: Total bilirubin < 1 x the institutional upper normal limits (UNL); ALAT/ASAT >= 3 x UNL (or >= 5 x UNL in case of liver metastases).
  • Serum albumin > 28g/L.
  • Availability of the last tumor imaging within 6 months prior to baseline tumor imaging
  • Availability of archived pathology specimen (paraffin-embedded block) from the tumor

Exclusion Criteria:

  • History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval.
  • Pregnant or lactating women or women of childbearing potential not using adequate contraception. Male patients not using adequate contraception.
  • Tumor sites that necessitate immediate intervention (supportive care, surgery or radiation therapy) such as symptomatic brain or leptomeningeal tumor, spinal cord compression, other compressive tumor masses, painful bone metastasis, bone fracture, etc…
  • Other serious illness or medical conditions, which, in the investigator's opinion could jeopardize patient's safety or hamper understanding of the study by the patient, patient's compliance to study treatment, or interpretation of study results. These conditions include (but are not restricted to):

    1. Congestive heart failure or angina pectoris not medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
    2. Existence of significant neurologic or psychiatric disorders impairing the ability to obtain consent.
    3. Active infection.
  • Concurrent treatment with other experimental therapies or participation in another clinical trial within 30 days prior to first study treatment administration.
  • Concurrent treatment with any other anticancer therapy (except LH-RH agonist therapy initiated > 2 months prior to study entry).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724320

Contacts
Contact: Patrice HERAIT, MD +33 6 85 12 ext 00 18 pherait@phconsult-onco.com

Locations
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Ahmad AWADA, MD    +32 2 541 ext 31 89    ahmad.awada@bordet.be   
Principal Investigator: Ahmad AWADA, MD         
France
Hopital Beaujon - AP-HP Recruiting
Clichy, France, 92110
Contact: Eric RAYMOND, MD    +33 1 40 87 ext 56 17    eric.raymond@bjn.aphp.fr   
Principal Investigator: Eric RAYMOND, MD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Jean-Pierre DELORD, MD    +33 5 67 22 ext 25 67    delord.jean-pierre@claudiusregaud.fr   
Principal Investigator: Jean-Pierre DELORD, MD         
Sponsors and Collaborators
OncoEthix
  More Information

No publications provided

Responsible Party: OncoEthix
ClinicalTrials.gov Identifier: NCT01724320     History of Changes
Other Study ID Numbers: OTX008_101
Study First Received: November 2, 2012
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins
France: Committee for the Protection of Personnes

Keywords provided by OncoEthix:
solid tumors
first-in-man
phase I
cancer
galectin

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014