Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)

A Phase 2 study testing PLX3397 in people with Prostate Cancer, run by Daiichi Sankyo at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC. Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: PLX3397
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesUnited States
Study dates: 25 May 2012to 11 Mar 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Histologically confirmed prostate cancer, currently with objective progressive disease.
Castrate level of testosterone (<50 ng/dL).
Baseline circulating tumor cell (CTC) count ≥10/7.5 mL blood.
Archival tumor tissue (unstained sections, paraffin block, or frozen tumor tissue) has been requisitioned for shipment to the central laboratory.
Karnofsky performance status of 80-100.
Adequate organ and marrow function.

Who cannot join

The subject has received:
Any systemic chemotherapy (including investigational agents) within 4 weeks (with the exception of nitrosoureas/mitomycin C within 6 weeks), of the first dose of study treatment, OR
Biological agents (antibodies, immune modulators, cytokines, or vaccines) within 6 weeks of the first dose of study treatment, OR
Hormonal anticancer therapy (not including LHRH agonists or antagonists) within 2 weeks before the first dose of study treatment. Specific restrictions on prior hormonal and other anticancer treatments are detailed in inclusion criterion, OR
Small-molecular kinase inhibitors or any other type of investigational agent within 4 weeks before the first dose of study treatment or 5 half-lives of the compound or active metabolite, whichever is shorter.
The subject has received drugs used to control loss of bone mass (e.g., bisphosphonates) within 4 weeks prior to the first dose of study treatment.

Show all 14Show fewer

The subject has symptomatic or uncontrolled brain metastasis or epidural disease requiring current treatment including steroids and anti-convulsants.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >450 ms at screening.
The subject has uncontrolled or significant intercurrent illness including, but not limited to, the following conditions:
Cardiovascular disorders such as symptomatic congestive heart failure (CHF), *Uncontrolled hypertension
Unstable angina pectoris, clinically-significant cardiac arrhythmias
History of stroke (including transient ischemic attack [TIA] or other ischemic event) within 6 months of study treatment
Myocardial infarction within 6 months of study treatment
History of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: A Pilot Study of PLX3397 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients With Bone Metastasis and High Circulating Tumor Cell (CTC) Counts

The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC.

Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects.

Conditions: Prostate Cancer
Being tested: PLX3397
Keywords: CRPC, Prostate Cancer, Bone metastasis, Advanced Castration-Resistant Prostate Cancer (CRPC)
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PLX3397Drug
Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.

Study groups in NCT01499043
Study group	Role	What they receive
PLX3397	Experimental	Participants will take daily oral dose of PLX3397 for 28 day cycles. Participants will continue to take PLX3397 until disease progression or toxicity. Receives: Drug: PLX3397

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells
Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay)
CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up.
Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication was to continue until the progression had been confirmed.
Measured: See measure description for time frame.

Secondary outcomes (2)

Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term
Measured: Assessed from first dose through at least 4 weeks after the last dose.
Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade
Adverse events (AEs) were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0, where 1=mild, 2=moderate, 3=severe, 4=life-threatening, and 5=death related to AE.
Measured: Assessed from first dose through at least 4 weeks after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201211 Mar 2013

First posted26 Dec 2011 (estimated)
Study start25 May 2012
Primary completion11 Mar 2013
Study completion11 Mar 2013

Why it stopped: Business decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01499043
Sponsor's protocol ID: PLX108-06
Status last verified: Feb 2020
First submitted: 20 Dec 2011
Last updated: 4 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of PLX3397 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients With Bone Metastasis and High Circulating Tumor Cell (CTC) Counts
ClinicalTrials.gov ID: NCT01499043
Acronym / sponsor ID: PLX108-06
Conditions: Prostate Cancer
Keywords: CRPC, Prostate Cancer, Bone metastasis, Advanced Castration-Resistant Prostate Cancer (CRPC)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision.
Enrolment: 6 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Collaborators: Plexxikon
Study start: 25 May 2012 (actual)
Primary completion: 11 Mar 2013 (actual)
Study completion: 11 Mar 2013 (actual)
First posted: 26 Dec 2011 (estimated)
Results: Posted 18 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this study is to evaluate the effects of PLX3397 on male subjects with CRPC.

Secondary objectives include evaluating the safety and tolerability of PLX3397 and the anti-tumor effects that PLX3397 has on the the subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PLX3397	Experimental	Drug: PLX3397Participants will take daily oral dose of PLX3397 for 28 day cycles. Participants will continue to take PLX3397 until disease progression or toxicity.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Histologically confirmed prostate cancer, currently with objective progressive disease.
Castrate level of testosterone (<50 ng/dL).
Baseline circulating tumor cell (CTC) count ≥10/7.5 mL blood.
Archival tumor tissue (unstained sections, paraffin block, or frozen tumor tissue) has been requisitioned for shipment to the central laboratory.
Karnofsky performance status of 80-100.

Key exclusion criteria (14 listed)

The subject has received:
The subject has received drugs used to control loss of bone mass (e.g., bisphosphonates) within 4 weeks prior to the first dose of study treatment.
The subject has symptomatic or uncontrolled brain metastasis or epidural disease requiring current treatment including steroids and anti-convulsants.
The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >450 ms at screening.
The subject has uncontrolled or significant intercurrent illness including, but not limited to, the following conditions:

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
PLX3397Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.	Drug	PLX3397

Primary outcome

Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells
Time frame: See measure description for time frame.
Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay) CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up. Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication was to continue until the progression had been confirmed.

2 secondary outcomes

Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term
Time frame: Assessed from first dose through at least 4 weeks after the last dose.
Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade
Time frame: Assessed from first dose through at least 4 weeks after the last dose.

Results and safety

Results posted to the registry on 18 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PLX3397	6	0

Primary outcome: Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells

Time frame: See measure description for time frame.

Population analysed: The study was discontinued and the primary outcome measure was not evaluated. Consequently, no efficacy was evaluated and only safety results are reported. Raw data collected but no efficacy analysis was performed/reported.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from after first dose to 28 days after last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLX3397	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6

Limitations and caveats (from the sponsor): This study did not meet its planned enrollment goal of 20 participants by the end of 2012. Therefore, enrollment was terminated and efficacy was not evaluated; only the safety results are reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLX3397 in people with Prostate Cancer, run by Daiichi Sankyo at 2 sites in United States.

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 6 inclusion and 14 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells (time frame: See measure description for time frame.). 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 NCT01499043.

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 4 Mar 2020.