Castration-resistant Prostate Cancer, Advanced Breast CancerPhase 1NCT01610050
A Phase I Study of LFA102 in Japanese Patients
A Phase 1 study testing LFA102 in people with Castration-resistant Prostate Cancer, Advanced Breast Cancer, run by Novartis Pharmaceuticals at 3 sites in Japan.
Trial summary
This study will evaluate safety and tolerability to determine the MTD/RD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castration-resistant Prostate Cancer, Advanced Breast Cancer
- What is being tested?
- LFA102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesJapan
- Study dates
- Jun 2012to Feb 2014
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of prostate cancer
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer
Who cannot join
- Patients with untreated and/or symptomatic metastatic CNS disease
- Prior anaphylactic or other severe infusion reaction
- Treatment with agent which affect prolactin levels
- Active autoimmune disease
- Other protcol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Kobe, Hyōgo, 650-0017
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560
About this study
Official title: A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
This study will evaluate safety and tolerability to determine the MTD/RD.
Read the detailed description
This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.
This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.
- Being tested
- LFA102
- Keywords
- castration-resistant prostate cancer, advanced breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFA102Drug
Also called anti prolactin receptor humanized monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| LFA102 | Experimental | Not described Receives: Drug: LFA102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
Frequency and severity of dose limiting toxicities (DLTs)
Measured: 1st treatment cycle (28 days)
Secondary outcomes (6)
Frequency, duration and severity of Adverse Events (AEs)
Frequency, duration and severity of all AEs will be collected.
Measured: at informed consent, until 28 days after treatment discontinuation
Serum Concentration
Measured: cycle 1 day 1 until disease progression
Objective Response Rate
Assessed based on RECIST/PCWG2 criteria
Measured: every 8 week or 12 weeks, until disase progression
Antibodies against LFA102
Serum concentration of antibodies against LFA102
Measured: day 1 of each treatment cycle until disease progression
Progression Free Survival
Assessed based on RECIST/PCWG2 criteria
Measured: every 8 or 12 weeks until disease progression
PK parameters
Cmax, Tmax, AUC, T1/2, CL and V
Measured: cycle 1 day 1 until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant Prostate Cancer, Advanced Breast CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01610050
- Sponsor's protocol ID
- CLFA102X1101
- Status last verified
- Nov 2014
- First submitted
- 30 May 2012
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Japanese Patients With Castration-resistant Prostate Cancer or Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01610050
- Acronym / sponsor ID
- CLFA102X1101
- Keywords
- castration-resistant prostate cancer, advanced breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Jun 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 will evaluate safety and tolerability to determine the MTD/RD.
Detailed description
This is a phase I open-label, multi-center, dose escalation study in Japanese patients with CRPC or advanced BC. LFA102 will be administered intravenously once every 4 weeks during the study. All patients will remain on treatment until they meet the criteria for study discontinuation (e.g. disease progression, unacceptable toxicity, patient withdrawal) or study closure.
This study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of LFA102. Each cohort will enroll a minimum of 3 patients. A two-parameter Bayesian logistic regression model employing the escalation with overdose control principle will be used during the escalation phase for dose level selection and for determination of the MTD or RD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LFA102 | Experimental | Drug: LFA102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed diagnosis of prostate cancer
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer
Key exclusion criteria (5 listed)
- Patients with untreated and/or symptomatic metastatic CNS disease
- Prior anaphylactic or other severe infusion reaction
- Treatment with agent which affect prolactin levels
- Active autoimmune disease
- Other protcol-defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| LFA102Also: anti prolactin receptor humanized monoclonal antibody | Drug | LFA102 |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: 1st treatment cycle (28 days)
Frequency and severity of dose limiting toxicities (DLTs)
6 secondary outcomes
Frequency, duration and severity of Adverse Events (AEs)
Time frame: at informed consent, until 28 days after treatment discontinuation
Serum Concentration
Time frame: cycle 1 day 1 until disease progression
Objective Response Rate
Time frame: every 8 week or 12 weeks, until disase progression
Antibodies against LFA102
Time frame: day 1 of each treatment cycle until disease progression
Progression Free Survival
Time frame: every 8 or 12 weeks until disease progression
PK parameters
Time frame: cycle 1 day 1 until disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LFA102 in people with Castration-resistant Prostate Cancer, Advanced Breast Cancer, run by Novartis Pharmaceuticals at 3 sites in Japan.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose Limiting Toxicities (DLT) (time frame: 1st treatment cycle (28 days)). 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 11 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.