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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01724320
• Date of registration: 02/11/2012
• Prospective Registration: No
• Primary sponsor: OncoEthix
• Public title: A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
• Scientific title: A Phase I, First-in-man Study of OTX008 Given Subcutaneously as a Single Agent to Patients With Advanced Solid Tumors
• Date of first enrolment: February 2012
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01724320
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium, France

Contacts

• Name: Patrice HERAIT, MD

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Solid Tumors

Intervention(s)

Drug: OTX008

Primary Outcome(s)

Dose Limiting Toxicity [Time Frame: up to 3 weeks of OTX008 treatment]

Secondary Outcome(s)

Pharmacokinetics (PK) [Time Frame: Days 1, 2 and 22 of OTX008 treatment]

Pharmacodynamics (PD) [Time Frame: Days 1 and 22 of OTX008 treatment]

Secondary ID(s)

OTX008_101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors