E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic prostate cancer |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Phase I: Incidence rate of dose limiting toxicities (DLT)
Phase II:Rate of patients with PSA response |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Phase I: 1st cycle of treatment
Phase II:baseline, >= 12 weeks |
|
E.5.2 | 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 |
|
E.5.2.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
France |
Singapore |
Spain |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of study is defined as the time when the last patient completes the study evaluation completion (SEC) follow-up visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |