Prostatic NeoplasmsPhase 1NCT01647789
A Study of Oral CFG920 in Patients With Castration Resistant Prostate Cancer
A Phase 1 study testing CFG920 in people with Prostatic Neoplasms, run by Novartis Pharmaceuticals at 7 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- CFG920
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 4 Dec 2012to 3 Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States4 sites
University of Wisconsin Univ Wisc
Madison, Wisconsin, 53792
Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(2)
San Antonio, Texas, 78229
UCSF Medical Center Dept of Oncology
San Francisco, California, 94143
Seattle Cancer Care Alliance Dept. of SCCA
Seattle, Washington, 98105
About this study
Official title: A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
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.
- Conditions
- Prostatic Neoplasms
- Being tested
- CFG920
- Keywords
- prostate cancer, castration resistant,
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFG920Drug
| Study group | Role | What they receive |
|---|---|---|
| CFG920 | Experimental | Not described Receives: Drug: CFG920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of dose limiting toxicities (DLT)
Phase l; cycle = 28 days
Measured: 28 days (from the time of first dose)
Incidence rate of patients with Prostate Specific Antigen (PSA) response
Phase ll only
Measured: >= 12 weeks
Secondary outcomes (10)
Number of adverse events (AEs)
Phase l, Phase ll
Measured: 18 months
PK parameters
Phase l, Phase ll
Measured: 18 months
Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)
Phase l only
Measured: 18 months
Progression free survival (PFS)
Phase ll only; cycle = 28 days
Measured: baseline, until disease progression up to 6 months (6 cycle)
Number of serious adverse events (SAEs)
Phase l, Phase ll
Measured: 18 months
Time to PSA progression
Phase ll; cycle = 28 days
Measured: up to 2 months (cycle 2)
Overall Response rate (ORR)
Phase ll
Measured: up to 2 months (cycle 2)
Radiological Time to Progression (rTTP)
Phase ll only
Measured: baseline, until date of documented disease progression
Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)
Phase ll only
Measured: 18 months
Best PSA response at any time during the study
Phase ll only
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start4 Dec 2012
- Primary completion3 Feb 2016
- Study completion3 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647789
- Sponsor's protocol ID
- CCFG920X2101
- Other IDs
- 2012-001961-33
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2012
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multicenter, Open-label Dose Finding Study of Oral CFG920 in Patients With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01647789
- Acronym / sponsor ID
- CCFG920X2101
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate cancer, castration resistant,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2012 (actual)
- Primary completion
- 3 Feb 2016 (actual)
- Study completion
- 3 Feb 2016 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CFG920 | Experimental | Drug: CFG920 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFG920 | Drug | CFG920 |
Primary outcome
Incidence rate of dose limiting toxicities (DLT)
Time frame: 28 days (from the time of first dose)
Phase l; cycle = 28 days
Incidence rate of patients with Prostate Specific Antigen (PSA) response
Time frame: >= 12 weeks
Phase ll only
10 secondary outcomes
Number of adverse events (AEs)
Time frame: 18 months
PK parameters
Time frame: 18 months
Prostate Specific Antigen (PSA) response (≥50% in PSA reduction)
Time frame: 18 months
Progression free survival (PFS)
Time frame: baseline, until disease progression up to 6 months (6 cycle)
Number of serious adverse events (SAEs)
Time frame: 18 months
Time to PSA progression
Time frame: up to 2 months (cycle 2)
Overall Response rate (ORR)
Time frame: up to 2 months (cycle 2)
Radiological Time to Progression (rTTP)
Time frame: baseline, until date of documented disease progression
Prostate Specific Antigen (PSA) response (≥30% in the PSA reduction)
Time frame: 18 months
Best PSA response at any time during the study
Time frame: 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CFG920 in people with Prostatic Neoplasms, run by Novartis Pharmaceuticals at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Belgium, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of dose limiting toxicities (DLT) (time frame: 28 days (from the time of first dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.