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

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2012-001961-33-BE
• Date of registration: 12/11/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: An interventional study of oral CFG920 in patients with castration resistant prostate cancer
• Scientific title: A phase I/II, multicenter, open-label dose finding study of oral CFG920 in patients with metastatic castration-resistant prostate cancer
• Date of first enrolment: 03/12/2012
• Target sample size: 75
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001961-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium, Canada, France, Singapore, Spain, United States

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
-Confirmed diagnosis of castration resistant prostate cancer
-Documented metastases
- ECOG performance status 0 or 1
-Documented progression following the Prostate Cancer Working Group
2 guidelines
- Fresh or archived tumor sample
- Other protocol-defined inclusion criteria may apply
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 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion criteria:
- Impaired cardiac function
- Uncontrolled hypertension despire appropriate medical therapy
- History of pituitary or adrendal dysfunction
- Chronic steriod therapy other than daily use of 10mg prednisone
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral CFG920
- Brain metastases that have not been adequately treated
- Malignant disease other than that being treated in this study
-Laboratory abnormalities as specified in the protocol
Other protocol-defined exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Metastatic prostate cancer
MedDRA version: 17.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

Product Code: CFG920
Pharmaceutical Form: Capsule
Current Sponsor code: CFG920
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Code: CFG920
Pharmaceutical Form: Capsule
Current Sponsor code: CFG920
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Phase I: Incidence rate of dose limiting toxicities (DLT)
Phase II:Rate of patients with PSA response

Secondary Objective: 1. Phase I and II: To characterize the safety and tolerability of CFG920,
including both acute and chronic toxicities
2. Phase I and II: To characterize the PK of CFG920
3. Phase I : Evaluate preliminary antitumor activity
4. Phase II: Evaluate preliminary antitumor activity

Main Objective: Phase I:To estimate the Maximum Tolerated Dose (MTD) or recommended phase II dose (RP2D) of oral CFG920 when co-administered with prednisone to adult patients with castration-resistant prostate cancer.
Phase II: To assess preliminary anti-tumor activity of CFG920 across 3 castration-resistant prostate cancer groups:1) Abiraterone- naïve, 2) Abiraterone primary resistant, 3) Abiraterone secondary resistant

Timepoint(s) of evaluation of this end point: Phase I: 1st cycle of treatment
Phase II:baseline, >= 12 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. 18 months
2.18 months
3. 18 months
4. a) baseline, until disease progression up to 6 months (6 cycle), b) and
c) up to 2 months (cycle 2), d) baseline, until date of documented
disease progression e) and f) 18 months

Secondary end point(s): 1. Number of adverse events (AEs), Number of serious adverse events
(SAEs)
2. PK parameter
3. Prostate specific antigen (PSA) response (=50% in PSA reduction),
4. a) Progression free survival (PFS), b)Time to PSA progression,
c)Overall Response rate (ORR), d)Radiological Time to Progression
(rTTP), e)Prostate Specific Antigen (PSA) response (=30% in the PSA
reduction, f)Best PSA response at any time during the study

Secondary ID(s)

CFG920X2101

2012-001961-33-ES

Source(s) of Monetary Support

Novartis Pharma service AG