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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01724320
Recruitment Status : Unknown
Verified November 2012 by Oncoethix GmbH.
Recruitment status was:  Recruiting
First Posted : November 9, 2012
Last Update Posted : November 9, 2012
Information provided by (Responsible Party):
Oncoethix GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: OTX008 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: up to 3 weeks of OTX008 treatment ]
    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 :
  1. Pharmacokinetics (PK) [ Time Frame: Days 1, 2 and 22 of OTX008 treatment ]
    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)

  2. Pharmacodynamics (PD) [ Time Frame: Days 1 and 22 of OTX008 treatment ]
    Following parameter will be measured: plasma levels of galectin-1

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01724320

Contact: Patrice HERAIT, MD +33 6 85 12 ext 00 18

Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Ahmad AWADA, MD    +32 2 541 ext 31 89   
Principal Investigator: Ahmad AWADA, MD         
Hopital Beaujon - AP-HP Recruiting
Clichy, France, 92110
Contact: Eric RAYMOND, MD    +33 1 40 87 ext 56 17   
Principal Investigator: Eric RAYMOND, MD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Jean-Pierre DELORD, MD    +33 5 67 22 ext 25 67   
Principal Investigator: Jean-Pierre DELORD, MD         
Sponsors and Collaborators
Oncoethix GmbH

Responsible Party: Oncoethix GmbH Identifier: NCT01724320     History of Changes
Other Study ID Numbers: OTX008_101
First Posted: November 9, 2012    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Keywords provided by Oncoethix GmbH:
solid tumors
phase I