EC122 HER-1 Prostate Phase I

Phase 1

Completed

• Conditions: Hormone refractory prostate cancer; Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Urogenital Diseases, Male; Prostatic Diseases

• Registration Number: RPCEC00000219
• Lead Sponsor: Center of Molecular Immunology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-15
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

1. Patients who meet the diagnostic criteria.
2. Patients with greater than or equal to 40 years age.
3. Patients who have signed informed consent.
4. Patients with overall as less than 2 ECOG.
5. Patients with longer life expectancy of 6 months.
6. Patients with functioning of organs and bone marrow, defined by the following parameters:
- Hemoglobin greater than or equal to 90 g / l
- White blood cell count, greater than or equal to 3.0 x 109 leucocytes / L
- Absolute Neutrophil Count, greater than or equal to 1.5 x Neutrophil 109 / L
- Platelets greater than or equal to 100 x 109 platelets / L
- Bilirubin values within normal limits of the institution. (0 to 17 micromol / L).
- TGO/TGP less than or equal to 2.5 times the upper limit of the normal range in the institution.
- Creatinine values within normal limits of the institution. (35-135 micromol / L)

Exclusion Criteria

1.Patients receiving other onco-specific investigational product.
2.Patients with uncontrolled intercurrent illness including: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, liver damage and psychiatric illness that may limit adherence to clinical trial requirements.
3. Patients with brain metastases.
4. Patients with compromised immune systems, including current disease or history of eczema, atopic dermatitis, autoimmune disease (autoimmune neutropenia, thrombocytopenia, hemolytic anemia, HIV, lupus erythematosus, Sjogen syndrome, scleroderma, myasthenia gravis Goodpasture syndrome, Addison's disease, Hashimoto's thyroiditis, Graves' disease).
5. Allergic patient to any component of the formulation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified