Prostate CancerPhase 2NCT00638378

Study of Ruxolitinib (INCB018424) Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

A Phase 2 study testing Ruxolitinib in people with Prostate Cancer, run by Incyte Corporation at 15 sites in United States.

Terminated

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

Official record

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Trial summary

This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens or ketoconazole) for metastatic, androgen-independent prostate cancer. 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?: Ruxolitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 15 sitesUnited States
Study dates: Feb 2008to Jan 2009
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

Diagnosed with radiographically-documented metastatic prostate cancer that has progressed while receiving androgen-suppressive therapy in the form of a bilateral orchiectomy or Gonadotropin-Releasing Hormone (GnRH) agonist (eg, leuprolide, goserelin).
Patients must demonstrate evidence of progressive disease based on 1 of the following criteria: 1) Progressive measurable disease, or 2) Progressive rise in prostate-specific antigen (PSA) level (2 consecutive rises from a prior reference level), or 3) Development of new lesions on bone scan.
If receiving a GnRH agonist as primary hormonal therapy, the serum testosterone level must be ≤ 50 ng/mL.
Must have received and progressed during or following 1 prior chemotherapy regimen for metastatic disease (not including an anti-androgen or ketoconazole); or, must have discontinued prior systemic therapy because of poor tolerance or other adverse effects; or, must have refused chemotherapy treatment. Patients having undergone more than 1 prior chemotherapy regimen may be admitted at the discretion of the sponsor.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Baseline serum PSA level of ≥ 10 ng/mL

Who cannot join

Received any anti-cancer medications in the 30 days before receiving their first dose of study medication except for GnRH agonists and bisphosphonates.
Any unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Bethlehem, Pennsylvania
Study site
Bismarck, North Dakota
Study site
Cherry Hill, New Jersey
Study site
Galesburg, Illinois
Study site
Grand Rapids, Michigan
Study site
Great Falls, Montana, 59405
Study site
Highland, California
Study site
Jefferson City, Missouri
Study site
Lacey, Washington
Study site
Montebello, California
Study site
Mountain View, California
Study site
Overland Park, Kansas
Study site
Staten Island, New York
Study site
Sumter, South Carolina
Study site
Wichita, Kansas

Other trials in United States

About this study

Official title: A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer

Conditions: Prostate Cancer
Being tested: Ruxolitinib
Keywords: Prostate Cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

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

RuxolitinibDrug
Also called INCB018424
Ruxolitinib 25 mg tablets taken with water twice a day.

Study groups in NCT00638378
Study group	Role	What they receive
Ruxolitinib	Experimental	Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit. Receives: Drug: Ruxolitinib

What is being measured

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

Number of Participants With a Prostate-specific Antigen Response
A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.
Measured: Assessed monthly from Baseline until the end of study (up to 8 months)
Number of Participants With Adverse Events (AE)
A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Measured: From Baseline through to the end of study (up to 8 months)

Secondary outcomes (2)

Time to Progression
The time from first dosing day to the date of disease progression:
- Progressive measurable disease by RECIST criteria (regardless of bone scan or prostate-specific antigen (PSA) results).
- Development of unequivocal new lesions on bone scan without clinical suspicion of a "flare" reaction.
- In patients who responded or had a decreased PSA from Baseline, a rise of 50% from PSA nadir, if the increase is ≥ 5 ng/mL or back to Baseline and confirmed by a 2nd value.
- In patients with no decrease in PSA from Baseline, a 25% rise over Baseline and ≥ 5 ng/mL confirmed by a 2nd value.
Measured: From Baseline until the end of study (up to 8 months).
Number of Participants With a Complete Response or Partial Response
Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits.
Measured: From Baseline through the end of study (up to 8 months)

Timeline

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

Feb 2008Jan 2009

First posted19 Mar 2008 (estimated)
Study startFeb 2008
Primary completionJan 2009
Study completionJan 2009

Why it stopped: According to the protocol, the sponsor terminated the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response.

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 Incyte CorporationThe 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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00638378
Sponsor's protocol ID: INCB 18424-254
Status last verified: Jan 2018
First submitted: 12 Mar 2008
Last updated: 12 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label Study of INCB018424 Administered Orally to Patients With Androgen Independent Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT00638378
Acronym / sponsor ID: INCB 18424-254
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: According to the protocol, the sponsor terminated the study after it was determined that less than 2 of the first 22 patients showed a PSA50 response.
Enrolment: 22 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 19 Mar 2008 (estimated)
Results: Posted 20 Jan 2012

Clinical summary

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

Study design

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

Arm	Type	Receives
Ruxolitinib	Experimental	Drug: RuxolitinibParticipants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.

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)

Diagnosed with radiographically-documented metastatic prostate cancer that has progressed while receiving androgen-suppressive therapy in the form of a bilateral orchiectomy or Gonadotropin-Releasing Hormone (GnRH) agonist (eg, leuprolide, goserelin).
Patients must demonstrate evidence of progressive disease based on 1 of the following criteria: 1) Progressive measurable disease, or 2) Progressive rise in prostate-specific antigen (PSA) level (2 consecutive rises from a prior reference level), or 3) Development of new lesions on bone scan.
If receiving a GnRH agonist as primary hormonal therapy, the serum testosterone level must be ≤ 50 ng/mL.
Must have received and progressed during or following 1 prior chemotherapy regimen for metastatic disease (not including an anti-androgen or ketoconazole); or, must have discontinued prior systemic therapy because of poor tolerance or other adverse effects; or, must have refused chemotherapy treatment. Patients having undergone more than 1 prior chemotherapy regimen may be admitted at the discretion of the sponsor.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Key exclusion criteria (2 listed)

Received any anti-cancer medications in the 30 days before receiving their first dose of study medication except for GnRH agonists and bisphosphonates.
Any unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy, except for stable chronic toxicities not expected to resolve, such as peripheral neurotoxicity.

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
RuxolitinibAlso: INCB018424Ruxolitinib 25 mg tablets taken with water twice a day.	Drug	Ruxolitinib

Primary outcome

Number of Participants With a Prostate-specific Antigen Response
Time frame: Assessed monthly from Baseline until the end of study (up to 8 months)
A prostate-specific antigen (PSA) response was defined as a PSA decline from Baseline of 50% or greater, repeated on 2 occasions at least 4 weeks apart.
Number of Participants With Adverse Events (AE)
Time frame: From Baseline through to the end of study (up to 8 months)
A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 3.0: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

2 secondary outcomes

Time to Progression
Time frame: From Baseline until the end of study (up to 8 months).
Number of Participants With a Complete Response or Partial Response
Time frame: From Baseline through the end of study (up to 8 months)

Results and safety

Results posted to the registry on 20 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ruxolitinib	22	0

Primary outcome: Number of Participants With a Prostate-specific Antigen Response

Time frame: Assessed monthly from Baseline until the end of study (up to 8 months). Number. Unit: participants

Measure	Ruxolitinib n = 22
Value	0

Population analysed: The Intent-to-treat population, which included all patients enrolled in the study who took at least 1 dose of study medication.

Primary outcome: Number of Participants With Adverse Events (AE)

Time frame: From Baseline through to the end of study (up to 8 months). Number. Unit: Participants

Measure	Ruxolitinib n = 22
Any adverse event	22
Treatment-related adverse event	16
Serious adverse event	9
Grade 3 or 4 adverse event	13
Discontinued study medication due to adverse event	4
Discontinued study due to adverse events	1

Population analysed: The Safety population included all enrolled patients who received at least 1 dose of study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ruxolitinib	9 of 22 (40.9%)	21 of 22 (95.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
Prostate Cancer, Urinary Incontinence

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.

15 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 Ruxolitinib in people with Prostate Cancer, run by Incyte Corporation at 15 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 2 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 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 20 Jan 2012). 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?

Number of Participants With a Prostate-specific Antigen Response (time frame: Assessed monthly from Baseline until the end of study (up to 8 months)). 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?

On the ClinicalTrials.gov record for NCT00638378.

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 12 Feb 2018.