An interventional study of oral CFG920 in patients with castration resistant prostate cancer

Conditions: Metastatic prostate cancer
MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-001961-33-ES

Lead Sponsor: ovartis Farmacéutica S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 100

Inclusion Criteria

1. Age > 18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status grade 0-1
3. Suitable venous access for blood sampling
4. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma 5. Documented metastases determined by bone scan, CT-scan, or MRI
6. Documented ongoing castration condition defined by a serum testosterone levels of < 50 ng/dl (1.7 nmol/L).
7. Documented progressive disease, defined as per the PCWG2 guidelines
8. Minimum washout period of 4 weeks after the use of prostate cancer therapy and 6 weeks after stopping the antiandrogens bicalutamide and MDV3100
9. Anticoagulation is allowed if patients are already on a stable dose of warfarin or low molecular weight heparin for > 2 weeks at time of dose initiation
10. Concomitant use of bisphosphonates is allowed if the dose and renal function have been stable for at least 12 weeks before the enrollment
11. Laboratory values specified in the protocol
12. Patient is capable of understanding and complying with the protocol and has signed the informed consent document prior to the start of screening
Phase I only
13. Patients must have progressed on, are intolerant to, or have refused abiraterone acetate AND have progressed on, are intolerant to, or refused docetaxel
Phase II only
14. Patients must have progressed on, are intolerant to, or have refused docetaxel
Phase I/II abiraterone naïve patients
15. No prior treatment with CYP17 inhibitors or MDV3100
Phase I/II primary abiraterone-resistant CRPC
16. Disease progression while on continuous treatment with ABI or progression up to 30 days after the last dose of ABI
17. No intervening systemic therapy between cessation of ABI and initiation of CFG920 treatment
18. Patient has not demonstrated objective clinical benefit while on continuous treatment with ABI
Phase I/II secondary abiraterone-resistant CRPC
19. Disease progression while on continuous treatment with ABI or progression up to 30 days after the last dose of ABI
20. No intervening systemic therapy between cessation of ABI and initiation of CFG920 treatment
21. Patient demonstrated objective clinical benefit while on continuous treatment with ABI
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

1. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease
2. Major surgery within 28 days before study treatment and/or have not recovered fully from the adverse effects of any major surgical procedures before study treatment
3. Patients who have received radiotherapy ? 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
4. Chronic steroid therapy other than the following: Daily use of 10 mg prednisone or low dose steroid for the control of nausea and vomiting, topical steroid, or inhaled steroid use.
5. Participation in another clinical trial involving experimental therapy < 4 weeks prior to the first dose of study drug or ongoing in another experimental trial related to the treatment of prostate cancer
6. Current evidence of spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction
7. History of another primary malignancy that is currently clinically significant or currently requires active intervention
8. Uncontrolled hypertension despite appropriate medical therapy
9. History of pituitary or adrenal dysfunction
10. Gastrointestinal disorders or gastric by-pass surgery that could interfere with the swallowing and absorption of CFG920
11. Impaired cardiac function or clinically significant cardiac disease
12. History of an active infection requiring systemic therapy within 10 days before study treatment.
13. Known diagnosis of human immunodeficiency virus (HIV) infection
14. Evidence of active hepatitis viral infection such as hepatitis B or hepatitis C or chronic liver disease
15. Patients who are currently receiving prohibited medications listed in the protocol and cannot be discontinued at least 1 week prior to starting CFG920
16. Any condition that in the assessment of the investigator renders the patient not suitable for participation in this clinical study protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials