Castration-resistant Prostate CancerPhase 1NCT01338831
Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
A Phase 1 study testing LFA102 in people with Castration-resistant Prostate Cancer and Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 9 sites in 4 countries.
Trial summary
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma
- What is being tested?
- LFA102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Sep 2011to Mar 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, breast cancer, or uterine leiomyoma
- Detectable metastases by bone scan, CT-scan, or MRI.
- Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
- Suitable venous access for blood sampling
Who cannot join
- Prior treatment with any anti-prolactin receptor antibody
- Major surgery within 28 days before study treatment
- Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
- Prior anaphylactic or other severe infusion reaction to antibody formulations
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
United States5 sites
Massachusetts General Hospital Mass Gen 3
Boston, Massachusetts, 02114
University of Wisconsin Clinical Science Center
Madison, Wisconsin, 53792
Cancer Institute of New Jersey SC
New Brunswick, New Jersey, 08901
Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson
Philadelphia, Pennsylvania, 19107
University of Utah / Huntsman Cancer Institute Huntsman 3
Salt Lake City, Utah, 84103
Belgium2 sites
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Brussels, 1200
About this study
Official title: A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.
- Being tested
- LFA102
- Keywords
- prostate cancer,, breast cancer,, prolactin,, prolactin receptor, uterine leiomyoma
- Medical subject headings
- Breast Neoplasms, Myofibroma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFA102Drug
| Study group | Role | What they receive |
|---|---|---|
| Breast & Prostate Cancer Group | Experimental | Dose Escalation Receives: Drug: LFA102 |
| Breast Cancer Group | Experimental | Dose Expansion Receives: Drug: LFA102 |
| Prostate Cancer Group | Experimental | Dose Expansion Receives: Drug: LFA102 |
| Uterine Leiomyoma Group | Experimental | Dose Expansion Receives: Drug: LFA102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Dose Limiting Toxicity
Measured: 4 weeks
Secondary outcomes (3)
LFA102 serum concentration
Measured: 6 months
Disease response
Measured: every 2 to 3 months
Concentrations of antibodies to LFA102
Measured: every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Castration-resistant Prostate 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
- 73 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
- NCT01338831
- Sponsor's protocol ID
- CLFA102X2102
- Other IDs
- 2011-000494-32
- Status last verified
- Feb 2017
- First submitted
- 14 Apr 2011
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
Agarwal N, Machiels JP, Suarez C, Lewis N, Higgins M, Wisinski K, Awada A, Maur M, Stein M, Hwang A, Mosher R, Wasserman E, Wu G, Zhang H, Zieba R, Elmeliegy M. Phase I Study of the Prolactin Receptor Antagonist LFA102 in Metastatic Breast and Castration-Resistant Prostate Cancer. Oncologist. 2016 May;21(5):535-6. doi: 10.1634/theoncologist.2015-0502. Epub 2016 Apr 18.
PubMed 27091421
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. 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 Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01338831
- Acronym / sponsor ID
- CLFA102X2102
- Keywords
- prostate cancer,, breast cancer,, prolactin,, prolactin receptor, uterine leiomyoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Apr 2011 (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.
The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breast & Prostate Cancer Group | Experimental | Drug: LFA102Dose Escalation |
| Breast Cancer Group | Experimental | Drug: LFA102Dose Expansion |
| Prostate Cancer Group | Experimental | Drug: LFA102Dose Expansion |
| Uterine Leiomyoma Group | Experimental | Drug: LFA102Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma
- Detectable metastases by bone scan, CT-scan, or MRI.
- Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only)
- Suitable venous access for blood sampling
Key exclusion criteria (5 listed)
- Prior treatment with any anti-prolactin receptor antibody
- Major surgery within 28 days before study treatment
- Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug
- Prior anaphylactic or other severe infusion reaction to antibody formulations
- Other protocol-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 |
|---|---|---|
| LFA102 | Drug | Breast & Prostate Cancer Group, Breast Cancer Group, Prostate Cancer Group, Uterine Leiomyoma Group |
Primary outcome
Incidence rate of Dose Limiting Toxicity
Time frame: 4 weeks
3 secondary outcomes
LFA102 serum concentration
Time frame: 6 months
Disease response
Time frame: every 2 to 3 months
Concentrations of antibodies to LFA102
Time frame: every month
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 17 Dec 2020.
- Derived from this study: PubMed 27091421Agarwal N, Machiels JP, Suarez C, Lewis N, Higgins M, Wisinski K, Awada A, Maur M, Stein M, Hwang A, Mosher R, Wasserman E, Wu G, Zhang H, Zieba R, Elmeliegy M. Phase I Study of the Prolactin Receptor Antagonist LFA102 in Metastatic Breast and Castration-Resistant Prostate Cancer. Oncologist. 2016 May;21(5):535-6. doi: 10.1634/theoncologist.2015-0502. Epub 2016 Apr 18.
- Results for CLFA102X2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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RecruitingPhase 2
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Active, not recruitingPhase 2
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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
9 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 LFA102 in people with Castration-resistant Prostate Cancer and Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 9 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 4 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, Italy, 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 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?
Incidence rate of Dose Limiting Toxicity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338831, which also lists 1 linked publication.
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 17 Dec 2020.