GliomaPhase 2NCT00047879

Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas

A Phase 2 study testing PEG-interferon alfa-2b and Thalidomide in people with Glioma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioma
What is being tested?: PEG-interferon alfa-2b and Thalidomide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Oct 2002to Jun 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
Patients must have evaluable or measurable disease and have shown unequivocal evidence for tumor recurrence or progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and the initiation of treatment, a new 20 baseline MR/CT scan is required. The same type of scan, i.e., MRI or CT must be used throughout the period of treatment for tumor measurement.
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the following conditions apply:
They have recovered from the effects of surgery
Measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. Patients must have evaluable disease.
To best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively. If the 96 hour scan is more than 2 weeks from registration, the scan needs to be repeated.

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The baseline on-study MR/CT is performed within 14 days of registration and on a steroid dosage that has been stable. If the steroid dose is increased between the date of imaging and the initiation of Peg-Intron with or without Thalidomide, a new baseline MR/CT is required on stable steroids for 5 days.
Patient must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to study entry.
Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium scanning, MR spectroscopy or surgical documentation of disease.
Prior therapy. There are no limitations to number of prior therapies.
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Patients must be > 18 years old, and with a life expectancy > 8 weeks.
Patients must have a Karnofsky performance status of > 60.
Patients must have recovered from the toxic effects of prior therapy (including resolution of effects on laboratory values): 2 weeks from any investigational agent, 4 weeks from prior cytotoxic therapy, 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents e.g. tamoxifen, cis- retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the PI.
Patients must have adequate bone marrow function (WBC > 3,000/l, ANC > 1,500 mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 gm%), adequate liver function (SGOT and bilirubin < 2 times the upper limit of normal), and adequate renal function (creatinine < 1.5 mg/dL or creatinine clearance > 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion.
Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate.
Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control for 1 month prior, during and for 4 months after treatment with thalidomide. It has been proposed that thalidomide may interfere with hormonal-based contraception, therefore, barrier methods of contraception (i.e. diaphragm, condom) MUST be used rather than, or in addition to birth control pills.
No peripheral neuropathy > grade 1.
No concurrent use of other investigational agents.

Who cannot join

Patients must not have:
Serious active infection
Disease that will obscure toxicity or dangerously alter drug metabolism
Serious intercurrent medical illness.
Significant illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy.
Patients must not have received prior therapy with Peg-Intron or Thalidomide.
Concurrent chemotherapy, immunotherapy, or radiotherapy is not permitted.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas

This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron) alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself. Stopping the growth of new vessels can slow or prevent tumor growth. The Food and Drug Administration has approved various interferons for treating several diseases, including melanoma and some leukemias. These drugs block new vessel growth in patients with recurrent tumors, but in high doses they produce serious side effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high doses given several times a week. Thalidomide, currently approved to treat leprosy, also blocks development of new blood vessel formation. In a recent study of thalidomide given to 36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least 2 months, and at least 3 had responses to treatment lasting 6 to 14 months.

Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing following standard treatment and does not respond to radiation therapy may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests (including a pregnancy test for women of childbearing potential), and magnetic resonance imaging (MRI) or computed tomography (CT) of the head.

Patients will continue treatment cycles as long as the drug is tolerated without serious side effects and the tumor is not growing. While on the study, patients will undergo various tests and procedures as follows:

Physical and neurologic examinations every 6 weeks MRI or CT brain scan every 6 weeks to assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure.

Read the detailed description

Background:

There is a growing belief that angiogenesis inhibition represents a potentially promising, novel therapeutic approach to highly vascular solid tumors like malignant gliomas. Thalidomide and Peg-Intron (IFN - Interferon) are attractive drugs to use in combination to test the hypothesis of combination anti-angiogenesis therapy inhibition given their proven activity as single agents in patients with malignant gliomas and their spectrum of largely non-overlapping toxicities.

Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects of low dose, continuous IFN administration, we are interested in evaluating the use of pegylated IFN in combination with thalidomide. Thus, we are proposing a phase II trial of pegylated IFN with thalidomide in patients with recurrent gliomas.

Objectives:

To obtain preliminary evidence of anti-tumor efficacy of PEG-Intron in combination with thalidomide in patients with recurrent high grade gliomas as assessed by prolongation of progression-free survival compared to historical controls.

A secondary endpoint in this trial is to determine the response rate associated with the combination therapy in each of the two strata and to evaluate and document all toxicities from PEG-Intron in combination with thalidomide at the doses prescribed in this protocol in this patient population.

Eligibility:

Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).

Patients must not have received prior therapy with Peg-Intron or Thalidomide.

Design:

Patients will be treated with weekly PEG-Intron plus daily oral thalidomide. All patients will be treated for 6 weeks following which patients will have a repeat MRI scan to assess disease response.

Conditions: Glioma
Being tested: PEG-interferon alfa-2b, Thalidomide
Keywords: Brain Tumors, Experimental, Toxicities, Efficacy, Progression-Free, Brain Tumor, Glioma
Medical subject headings: Glioma, Brain Neoplasms

What participants receive

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

PEG-interferon alfa-2bBiological
Also called Pegasys
0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection
ThalidomideDrug
Also called Thalomid
Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.

Study groups in NCT00047879
Study group	Role	What they receive
Glioblastoma multiforme stratum	Other	Glioblastoma multiforme is one of the most common and aggressive types of brain tumor. Receives: Biological: PEG-interferon alfa-2b; Drug: Thalidomide
Anaplastic Glioma Stratum	Other	Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy. Receives: Biological: PEG-interferon alfa-2b; Drug: Thalidomide

What is being measured

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

Progression-free Survival
Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy.
Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles.
Measured: 6 months

Secondary outcomes (2)

Number of Participants With Complete or Partial Response
Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan.
Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component.
Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions.
Measured: 6 months
The Number of Participants With Adverse Events
Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Measured: 4 months

Timeline

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

Oct 2002Jun 2009

First posted23 Oct 2002 (estimated)
Study startOct 2002
Primary completionJun 2009
Study completionJun 2009

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 (3)Papers the sponsor has linked to this study.
Other trials for GliomaStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00047879
Sponsor's protocol ID: 030002
Other IDs: 03-C-0002, 030002
Status last verified: Sep 2011
First submitted: 19 Jun 2006
Last updated: 26 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Dinapoli RP, Brown LD, Arusell RM, Earle JD, O'Fallon JR, Buckner JC, Scheithauer BW, Krook JE, Tschetter LK, Maier JA, et al. Phase III comparative evaluation of PCNU and carmustine combined with radiation therapy for high-grade glioma. J Clin Oncol. 1993 Jul;11(7):1316-21. doi: 10.1200/JCO.1993.11.7.1316.
PubMed 8315428
Takamiya Y, Friedlander RM, Brem H, Malick A, Martuza RL. Inhibition of angiogenesis and growth of human nerve-sheath tumors by AGM-1470. J Neurosurg. 1993 Mar;78(3):470-6. doi: 10.3171/jns.1993.78.3.0470.
PubMed 8433151
Fine HA, Figg WD, Jaeckle K, Wen PY, Kyritsis AP, Loeffler JS, Levin VA, Black PM, Kaplan R, Pluda JM, Yung WK. Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. J Clin Oncol. 2000 Feb;18(4):708-15. doi: 10.1200/JCO.2000.18.4.708.
PubMed 10673511

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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Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

All Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas
ClinicalTrials.gov ID: NCT00047879
Acronym / sponsor ID: 030002
Conditions: Glioma
Keywords: Brain Tumors, Experimental, Toxicities, Efficacy, Progression-Free, Brain Tumor, Glioma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Oct 2002
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 23 Oct 2002 (estimated)
Results: Posted 26 Oct 2011

Clinical summary

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

Detailed description

Background:

Objectives:

Eligibility:

Patients must not have received prior therapy with Peg-Intron or Thalidomide.

Design:

Patients will be treated with weekly PEG-Intron plus daily oral thalidomide. All patients will be treated for 6 weeks following which patients will have a repeat MRI scan to assess disease response.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Glioblastoma multiforme stratum	Other	Biological: PEG-interferon alfa-2b, Drug: ThalidomideGlioblastoma multiforme is one of the most common and aggressive types of brain tumor.
Anaplastic Glioma Stratum	Other	Biological: PEG-interferon alfa-2b, Drug: ThalidomideAnaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.

Who may qualify

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

Key inclusion criteria (20 listed)

Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified).
Patients must have evaluable or measurable disease and have shown unequivocal evidence for tumor recurrence or progression by MRI or CT scan. This scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and the initiation of treatment, a new 20 baseline MR/CT scan is required. The same type of scan, i.e., MRI or CT must be used throughout the period of treatment for tumor measurement.
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the following conditions apply:
They have recovered from the effects of surgery
Measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. Patients must have evaluable disease.

Key exclusion criteria (7 listed)

Patients must not have:
Serious active infection
Disease that will obscure toxicity or dangerously alter drug metabolism
Serious intercurrent medical illness.
Significant illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy.

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
PEG-interferon alfa-2bAlso: Pegasys0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection	Biological	Anaplastic Glioma Stratum, Glioblastoma multiforme stratum
ThalidomideAlso: ThalomidTwo 50mg tablets (100 mg total dose) every night before bedtime starting on day one.	Drug	Anaplastic Glioma Stratum, Glioblastoma multiforme stratum

Primary outcome

Progression-free Survival
Time frame: 6 months
Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy. Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles.

2 secondary outcomes

Number of Participants With Complete or Partial Response
Time frame: 6 months
The Number of Participants With Adverse Events
Time frame: 4 months

Results and safety

Results posted to the registry on 26 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glioblastoma Multiforme Stratum	4	0
Anaplastic Glioma Stratum	3	0

Primary outcome: Progression-free Survival

Time frame: 6 months. Number. Unit: Percent of participants

Population analysed: The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glioblastoma Multiforme Stratum	3 of 4 (75%)	4 of 4 (100%)	Not reported
Anaplastic Glioma Stratum	2 of 3 (66.7%)	2 of 3 (66.7%)	Not reported

Limitations and caveats (from the sponsor): Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8315428Dinapoli RP, Brown LD, Arusell RM, Earle JD, O'Fallon JR, Buckner JC, Scheithauer BW, Krook JE, Tschetter LK, Maier JA, et al. Phase III comparative evaluation of PCNU and carmustine combined with radiation therapy for high-grade glioma. J Clin Oncol. 1993 Jul;11(7):1316-21. doi: 10.1200/JCO.1993.11.7.1316.
Background: PubMed 8433151Takamiya Y, Friedlander RM, Brem H, Malick A, Martuza RL. Inhibition of angiogenesis and growth of human nerve-sheath tumors by AGM-1470. J Neurosurg. 1993 Mar;78(3):470-6. doi: 10.3171/jns.1993.78.3.0470.
Background: PubMed 10673511Fine HA, Figg WD, Jaeckle K, Wen PY, Kyritsis AP, Loeffler JS, Levin VA, Black PM, Kaplan R, Pluda JM, Yung WK. Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. J Clin Oncol. 2000 Feb;18(4):708-15. doi: 10.1200/JCO.2000.18.4.708.
MedlinePlusLink provided by the sponsor.
Drug Information PortalLink provided by the sponsor.
U.S. FDA ResourcesLink provided by the sponsor.

Related trials for Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
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Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

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.

Howard A Fine, M.D. principal investigator

NCI, NIH

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PEG-interferon alfa-2b and Thalidomide in people with Glioma, run by National Cancer Institute (NCI) at 1 site 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 20 inclusion and 7 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 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 26 Oct 2011). 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?

Progression-free Survival (time frame: 6 months). 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 NCT00047879, which also lists 3 linked publications.

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 26 Oct 2011.