A Phase 1 interventional study of CFG920 in Prostatic Neoplasms, sponsored by Novartis Pharmaceuticals. Terminated at 7 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
This study was supposed to have assessed the safety and preliminary antitumor activity of CFG920, a new CYP17 inhibitor in castration resistant prostate cancer patients who are abiraterone naive or abiraterone resistant.
The study was terminated after Phase I (dose escalation phase) and Phase II part of the study was not initiated. Novartis voluntarily terminated this study and hence stopped further enrollment of patients into this study. As the decision to terminate the study was not due to any safety issues, the patients enrolled in the study by the time of this decision were allowed to continue with treatment per the protocol.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 31 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: CFG920
Incidence rate of dose limiting toxicities (DLT)
Phase l; cycle = 28 days
Time frame: 28 days (from the time of first dose)
Incidence rate of patients with Prostate Specific Antigen (PSA) response
Phase ll only
Time frame: >= 12 weeks
Number of adverse events (AEs)
Phase l, Phase ll
Time frame: 18 months
PK parameters
Phase l, Phase ll
Time frame: 18 months
Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)
Phase l only
Time frame: 18 months
Progression free survival (PFS)
Phase ll only; cycle = 28 days
Time frame: baseline, until disease progression up to 6 months (6 cycle)
Number of serious adverse events (SAEs)
Phase l, Phase ll
Time frame: 18 months
Time to PSA progression
Phase ll; cycle = 28 days
Time frame: up to 2 months (cycle 2)
Overall Response rate (ORR)
Phase ll
Time frame: up to 2 months (cycle 2)
Radiological Time to Progression (rTTP)
Phase ll only
Time frame: baseline, until date of documented disease progression
Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)
Phase ll only
Time frame: 18 months
Best PSA response at any time during the study
Phase ll only
Time frame: 18 months
Evaluation of serum hormone levels
Phase I, Phase II
Time frame: 18 months
Correlate plasma exposure parameters of CFG920 and serum hormones
Phase I, Phase II
Time frame: 18 months
Evaluate moleculare profiles
Phase I, Phase II
Time frame: 18 months
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals