Myeloproliferative Neoplasm (MPN)Phase 2NCT00726232
Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
A Phase 2 study testing Ruxolitinib in people with Myeloproliferative Neoplasm (MPN), run by Incyte Corporation at 4 sites in 2 countries.
Trial summary
To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm (MPN)
- 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
- 73 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Aug 2008to 20 Aug 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician
- Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.
- Patient meets baseline clinical lab parameters
Who cannot join
- Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.
- Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years
- Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day
- Clinically significant cardiac disease (New York Heart Association (NYHA) Class III or IV)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
Official title: A Phase 2, Open Label, Dose Regimen Ranging Clinical Study to Determine the Safety and Efficacy of INCB018424 in Patients With Advanced Polycythemia Vera or Essential Thrombocythemia Refractory to Hydroxyurea
To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group were refractory to hydroxyurea or for whom hydroxyurea is contraindicated.
Read the detailed description
The study consisted of a 2-stage design, which included a dose-ranging phase (during which patients received treatment at their randomized dose) and an expansion phase (after adjustment of dose/regimen to achieve an optimal balance of efficacy and safety). During the dose-ranging phase, patients in each disease group (PV or ET) were randomly assigned in a 1:1:1 ratio independent of each other to receive 1 of 3 treatment regimens with Ruxolitinib, 10 mg twice daily (bid), 25 mg bid, or 50 mg once daily (qd). After patients completed 2 cycles of treatment with Ruxolitinib at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis using their discretion in order to achieve an optimal balance of efficacy and safety. During the expansion phase (ie, after optimization of dose), additional patients with PV or ET were enrolled to receive Ruxolitinib at the dose that was selected upon review of data from the dose-ranging phase. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
- Conditions
- Myeloproliferative Neoplasm (MPN)
- Being tested
- Ruxolitinib
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called INCB018424
Ruxolitinib was administered orally and supplied as 5 mg and 25 mg tablets.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 10 mg BID | Experimental | Participants received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. Receives: Drug: Ruxolitinib |
| Ruxolitinib 25 mg BID | Experimental | Participants received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. Receives: Drug: Ruxolitinib |
| Ruxolitinib 50 mg QD | Experimental | Participants received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)
For a confirmed response all criteria must have been sustained for at least 2 months.
CR:
- Hematocrit < 45% in men and < 42% in women
- No phlebotomy for 1 month
- No palpable splenomegaly
- White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L
- No sustained leucopenia or thrombocytopenia (>2 weeks)
- No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss)
PR:
- Hematocrit < 45% in men and < 42% in women
- 50% reduction in phlebotomy requirements from 6 months before treatment started
- 50% reduction in palpable splenomegaly
Measured: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3
Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)
For a confirmed response all criteria must have been sustained for at least 2 months.
Complete Clinical Response:
- Platelet count < 400 x 10^9/L
- White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal
- Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges
- Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias)
- Absence of palpable splenomegaly
Partial Clinical Response:
- Platelet count < 400 x 10^9/L
- 50% reduction in palpable splenomegaly
Measured: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.
Secondary outcomes (9)
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
The individual components of clinical response included:
- Hematocrit (Hct) < 45% without phlebotomy
- Absence of palpable splenomegaly
- 50% reduction in spleen size
- Platelet count ≤ 400 x 10^9/L
- White blood cell (WBC) count ≤ 10 x 10^9/L
Measured: Baseline and Week 12 (Cycle 4, Day 1)
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
The individual components of clinical response included:
- Hematocrit (Hct) < 45% without phlebotomy
- Absence of palpable splenomegaly
- 50% reduction in spleen size
- Platelet count ≤ 400 x 10^9/L
- White blood cell (WBC) count ≤ 10 x 10^9/L
Measured: Baseline and Week 24 (Cycle 7, Day 1)
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
The individual components of clinical response included:
- Hematocrit (Hct) < 45% without phlebotomy
- Absence of palpable splenomegaly
- 50% reduction in spleen size
- Platelet count ≤ 400 x 10^9/L
- White blood cell (WBC) count ≤ 10 x 10^9/L
Measured: Baseline and Week 36 (Cycle 10, Day 1)
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks
The individual components of clinical response included:
- Platelet count ≤ 400 x 10^9/L
- White blood cell (WBC) count ≤ 10 x 10^9/L
- 50% reduction in spleen size
- Absence of palpable splenomegaly
Measured: Baseline and 4 weeks (Cycle 2, Day 1)
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
The individual components of clinical response included:
- Platelet count ≤ 400 x 10^9/L
- White blood cell (WBC) count ≤ 10 x 10^9/L
- 50% reduction in spleen size
- Absence of palpable splenomegaly
Measured: Baseline and 24 weeks (Cycle 7, Day 1)
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
The individual components of clinical response included:
- Platelet count ≤ 400 x 10^9/L
- White blood cell (WBC) count ≤ 10 x 10^9/L
- 50% reduction in spleen size
- Absence of palpable splenomegaly
Measured: Baseline and 36 weeks (Cycle 10, Day 1)
Change From Baseline to Week 4 in Polycythemia Vera Symptoms
Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.
For patients with Polycythemia Vera, queried symptoms included fever, itching/pruritus, bone pain and night sweats.
Measured: Baseline and Week 4 (Cycle 2, Day 1)
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Patients were asked to rate their symptoms on a scale of 0 (none) to 10 (worse possible) for the prior week giving the worst level of symptoms experienced during the preceding 7 days. A negative change from baseline score indicates improvement in symptoms.
For patients with essential thrombocythemia, queried symptoms included itching/pruritus, bone pain, night sweats, paresthesias (tingling or numbness), and weakness.
Measured: Baseline and Week 4 (Cycle 2, Day 1)
Change From Baseline to Week 4 in Health-related Quality of Life
Health-related Quality of Life was assessed using the Global Health Status/Quality of Life Scale of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale ranges from 0 to 100, with higher scores indicating higher quality of life.
Measured: Baseline and Week 4 (Cycle 2, Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study start20 Aug 2008
- Primary completion20 Jun 2010
- Study completion20 Aug 2018
Why it stopped: Termination of the clinical trial by sponsor.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative Neoplasm (MPN)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Assad, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726232
- Sponsor's protocol ID
- INCB 18424-256
- Other IDs
- Ruxolitinib, 2008-001382-28, 2008
- Status last verified
- Oct 2025
- First submitted
- 29 Jul 2008
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Pieri L, Pancrazzi A, Pacilli A, Rabuzzi C, Rotunno G, Fanelli T, Guglielmelli P, Fjerza R, Paoli C, Verstovsek S, Vannucchi AM. JAK2V617F complete molecular remission in polycythemia vera/essential thrombocythemia patients treated with ruxolitinib. Blood. 2015 May 21;125(21):3352-3. doi: 10.1182/blood-2015-01-624536. No abstract available.
PubMed 25999444
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open Label, Dose Regimen Ranging Clinical Study to Determine the Safety and Efficacy of INCB018424 in Patients With Advanced Polycythemia Vera or Essential Thrombocythemia Refractory to Hydroxyurea
- ClinicalTrials.gov ID
- NCT00726232
- Acronym / sponsor ID
- INCB 18424-256
- Conditions
- Myeloproliferative Neoplasm (MPN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Termination of the clinical trial by sponsor.
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2008 (actual)
- Primary completion
- 20 Jun 2010 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group were refractory to hydroxyurea or for whom hydroxyurea is contraindicated.
Detailed description
The study consisted of a 2-stage design, which included a dose-ranging phase (during which patients received treatment at their randomized dose) and an expansion phase (after adjustment of dose/regimen to achieve an optimal balance of efficacy and safety). During the dose-ranging phase, patients in each disease group (PV or ET) were randomly assigned in a 1:1:1 ratio independent of each other to receive 1 of 3 treatment regimens with Ruxolitinib, 10 mg twice daily (bid), 25 mg bid, or 50 mg once daily (qd). After patients completed 2 cycles of treatment with Ruxolitinib at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis using their discretion in order to achieve an optimal balance of efficacy and safety. During the expansion phase (ie, after optimization of dose), additional patients with PV or ET were enrolled to receive Ruxolitinib at the dose that was selected upon review of data from the dose-ranging phase. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib 10 mg BID | Experimental | Drug: RuxolitinibParticipants received 10 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| Ruxolitinib 25 mg BID | Experimental | Drug: RuxolitinibParticipants received 25 mg Ruxolitinib orally twice a day (BID) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
| Ruxolitinib 50 mg QD | Experimental | Drug: RuxolitinibParticipants received 50 mg Ruxolitinib orally once a day (QD) for 56 days (two 28-day cycles) during the dose-ranging phase. After patients completed 2 cycles of treatment at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis to achieve an optimal balance of efficacy and safety. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician
- Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.
- Patient meets baseline clinical lab parameters
Key exclusion criteria (4 listed)
- Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.
- Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years
- Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day
- Clinically significant cardiac disease (New York Heart Association (NYHA) Class III or IV)
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 was administered orally and supplied as 5 mg and 25 mg tablets. | Drug | Ruxolitinib 10 mg BID, Ruxolitinib 25 mg BID, Ruxolitinib 50 mg QD |
Primary outcome
Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)
Time frame: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3
For a confirmed response all criteria must have been sustained for at least 2 months. CR: * Hematocrit < 45% in men and < 42% in women * No phlebotomy for 1 month * No palpable splenomegaly * White blood cells < 10 x 10^9/L with normal differential and platelets < 400 x 10^9/L * No sustained leucopenia or thrombocytopenia (>2 weeks) * No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss) PR: * Hematocrit < 45% in men and < 42% in women * 50% reduction in phlebotomy requirements from 6 months before treatment started * 50% reduction in palpable splenomegaly
Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)
Time frame: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3.
For a confirmed response all criteria must have been sustained for at least 2 months. Complete Clinical Response: * Platelet count < 400 x 10^9/L * White blood cell count < 10 x 10^9/L with normal differential and Hematocrit ≤ upper limit of normal * Absence of sustained (> 2 weeks) anemia or leucopenia based on institutional normal ranges * Absence of systemic ET symptoms (pruritus, bone pain, weakness, night sweats, paresthesias) * Absence of palpable splenomegaly Partial Clinical Response: * Platelet count < 400 x 10^9/L * 50% reduction in palpable splenomegaly
9 secondary outcomes
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks
Time frame: Baseline and Week 12 (Cycle 4, Day 1)
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Time frame: Baseline and Week 24 (Cycle 7, Day 1)
Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Time frame: Baseline and Week 36 (Cycle 10, Day 1)
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks
Time frame: Baseline and 4 weeks (Cycle 2, Day 1)
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks
Time frame: Baseline and 24 weeks (Cycle 7, Day 1)
Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks
Time frame: Baseline and 36 weeks (Cycle 10, Day 1)
Change From Baseline to Week 4 in Polycythemia Vera Symptoms
Time frame: Baseline and Week 4 (Cycle 2, Day 1)
Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms
Time frame: Baseline and Week 4 (Cycle 2, Day 1)
Change From Baseline to Week 4 in Health-related Quality of Life
Time frame: Baseline and Week 4 (Cycle 2, Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25999444Pieri L, Pancrazzi A, Pacilli A, Rabuzzi C, Rotunno G, Fanelli T, Guglielmelli P, Fjerza R, Paoli C, Verstovsek S, Vannucchi AM. JAK2V617F complete molecular remission in polycythemia vera/essential thrombocythemia patients treated with ruxolitinib. Blood. 2015 May 21;125(21):3352-3. doi: 10.1182/blood-2015-01-624536. No abstract available.
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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.
Albert Assad, MD study director
Incyte Corporation
4 sites in 2 countries: 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 Myeloproliferative Neoplasm (MPN), run by Incyte Corporation at 4 sites in 2 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 3 inclusion and 4 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 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, 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 24 Feb 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?
Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) (time frame: Assessed after 2 cycles (56 days) of treatment on Day 1 of Cycle 3). 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 NCT00726232, 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 29 Oct 2025.