A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01647789
First received: July 6, 2012
Last updated: March 25, 2013
Last verified: March 2013
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Purpose
This study will assess 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Neoplasms |
Drug: CFG920 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Incidence rate of dose limiting toxicities (DLT) [ Time Frame: 28 days (from the time of first dose) ] [ Designated as safety issue: Yes ]Phase l; cycle = 28 days
- Incidence rate of patients with Prostate Specific Antigen (PSA) response [ Time Frame: >= 12 weeks ] [ Designated as safety issue: No ]Phase ll only
Secondary Outcome Measures:
- Number of adverse events (AEs) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Phase l, Phase ll
- PK parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase l, Phase ll
- Prostate Specific Antigen (PSA) response [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase l only
- Progression free survival (PFS) [ Time Frame: baseline, until disease progression up to 6 months (6 cycle) ] [ Designated as safety issue: No ]Phase ll only; cycle = 28 days
- Number of serious adverse events (SAEs) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]Phase l, Phase ll
- Time to PSA progression [ Time Frame: up to 2 months (cycle 2) ] [ Designated as safety issue: No ]Phase ll; cycle = 28 days
- Overall Response rate (ORR) [ Time Frame: up to 2 months (cycle 2) ] [ Designated as safety issue: No ]Phase ll
- Radiological Time to Progression (rTTP) [ Time Frame: baseline, until date of documented disease progression ] [ Designated as safety issue: No ]Phase ll only
- Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase ll only
- Best PSA response at any time during the study [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase ll only
Other Outcome Measures:
- Evaluation of serum hormone levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase I, Phase II
- Correlate plasma exposure parameters of CFG920 and serum hormones [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase I, Phase II
- Evaluate moleculare profiles [ Time Frame: 18 months ] [ Designated as safety issue: No ]Phase I, Phase II
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CFG920 | Drug: CFG920 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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 inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647789
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, California | |
| University of California San Francisco Dept of Oncology | Not yet recruiting |
| San Francisco, California, United States, 94101 | |
| Contact: Paula Dutton 415-353-9297 walshp@medicine.ucsf.edu | |
| Principal Investigator: Charles J. Ryan | |
| United States, Texas | |
| Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(2) | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Ellen Jones 210-614-4418 Jonese5@uthscsa.edu | |
| Principal Investigator: John Sarantopoulos | |
| United States, Washington | |
| Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Dept. of SCCA | Not yet recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Reina Hibbert rhibbert@seattlecca.org | |
| Principal Investigator: Robert Bruce Montgomery | |
| United States, Wisconsin | |
| University of Wisconsin Univ Wisc | Not yet recruiting |
| Madison, Wisconsin, United States, 53792 | |
| Contact: Jennifer Jane Heideman +1 608 263 6222 Phase1@medicine.wisc.edu | |
| Principal Investigator: Josh Lang | |
| Belgium | |
| Novartis Investigative Site | Recruiting |
| Bouge, Belgium, 5004 | |
| Brazil | |
| Novartis Investigative Site | Not yet recruiting |
| Rio de Janiero, RJ, Brazil, 24231-050 | |
| Novartis Investigative Site | Not yet recruiting |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Novartis Investigative Site | Not yet recruiting |
| Barretos, SP, Brazil, 14784-400 | |
| Novartis Investigative Site | Not yet recruiting |
| São Paulo, SP, Brazil, 01246-000 | |
| Canada, Ontario | |
| Novartis Investigative Site | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Spain | |
| Novartis Investigative Site | Recruiting |
| Barcelona, Cataluna, Spain, 08035 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01647789 History of Changes |
| Other Study ID Numbers: | CCFG920X2101, 2012-001961-33 |
| Study First Received: | July 6, 2012 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
prostate cancer, castration resistant, |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013