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

NCT ID: NCT01724320

Last Updated: 2012-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-05-31

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

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.

Conditions

Solid Tumors

Keywords

solid tumors; first-in-man; phase I; cancer; galectin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OTX008

Single-arm study of OTX008 given subcutaneously, daily without interruption to patients with advanced solid tumors. Starting dose: 65 mg/day.

Group Type: EXPERIMENTAL

OTX008

Intervention Type: DRUG

OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day

Interventions

OTX008

OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Jules Bordet

Brussels, , Belgium

Site Status: RECRUITING

Hopital Beaujon - AP-HP

Clichy, , France

Site Status: RECRUITING

Institut Claudius Regaud

Toulouse, , France

Site Status: RECRUITING

Countries

Belgium; France

Central Contacts

Patrice HERAIT, MD

Role: CONTACT

Phone: +33 6 85 12

Email: pherait@phconsult-onco.com

Facility Contacts

Ahmad AWADA, MD

Role: primary

Eric RAYMOND, MD

Role: primary

Jean-Pierre DELORD, MD

Role: primary

Other Identifiers

OTX008_101

Identifier Type: -

Identifier Source: org_study_id