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

NCT01724320 | Unknown Phase 1

• 1 other identifier: OTX008_101
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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

Conditions

Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

  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)

  up to 3 weeks of OTX008 treatment

Secondary Outcomes (2)

• Pharmacokinetics (PK)

  Days 1, 2 and 22 of OTX008 treatment

• Pharmacodynamics (PD)

  Days 1 and 22 of OTX008 treatment

Study Arms (1)

OTX008

EXPERIMENTAL

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

Drug: OTX008

Interventions

OTX008 DRUG

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

OTX008

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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):
• Congestive heart failure or angina pectoris not medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias.
• Existence of significant neurologic or psychiatric disorders impairing the ability to obtain consent.
• 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).

Sponsors & Collaborators

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

Study Sites (3)

Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Hopital Beaujon - AP-HP

Clichy, 92110, France

RECRUITING

Institut Claudius Regaud

Toulouse, 31052, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

compound 0118

Central Study Contacts

Patrice HERAIT, MD

CONTACT

+33 6 85 12; pherait@phconsult-onco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 9, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

FR (2); BE (1)