Stage III Squamous Cell Carcinoma of the HypopharynxPhase 2NCT00410826
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
A Phase 2 study testing erlotinib hydrochloride, cisplatin and 3-dimensional conformal radiation therapy in people with Stage III Squamous Cell Carcinoma of the Hypopharynx and Stage III Squamous Cell Carcinoma of the Larynx, run by University of Washington at 9 sites in United States.
Trial summary
This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- What is being tested?
- erlotinib hydrochloride, cisplatin and 3-dimensional conformal radiation therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2006to May 2012
- 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
- Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the World Health Organization (WHO) classification
- Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Sixth Edition (2002)
- Unresectable or resection with significant morbidity
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
- Bilirubin =< 1.5 x upper limit of normal (ULN)
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- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN
- Calculated creatinine clearance >= 55ml/min (using the Cockcroft-Gault formula)
- Platelet count >= 100 x 10^9 /L
- Absolute neutrophil count (ANC) >= 1.25 x 10^9 /L
- Signed informed consent
- Male and female patients with reproductive potential must use an acceptable contraceptive method
- Authorization from a dentist to begin radiation therapy
Who cannot join
- Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- Inability or unwillingness to comply with radiotherapy
- Evidence of clinically significant congestive heart failure; patients must be able to tolerate hydration required during cisplatin chemotherapy
- Diarrhea > grade 1 at the time of enrollment
- Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck
- Prior treatment with an investigational or marketed inhibitor of the EGFR pathway
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- Use of cytochrome P450 3A4 (CYP3A4) inducers
- Presence of systemic metastases (M1)
- Pregnant or breast-feeding women
- Known human immunodeficiency virus (HIV) infection
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of New Mexico Health Science CCOP
Albuquerque, New Mexico, 87131
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Tennessee Cancer Institute-Boston Cancer Group PLC
Memphis, Tennessee, 38104
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
Multicare Health System
Tacoma, Washington, 98415
New Hanover Radiation Oncology Center
Wilmington, North Carolina, 28401
About this study
Official title: Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer
Read the detailed description
PRIMARY OBJECTIVES:
- Compare the complete response rate in patients with locally advanced head and neck cancer, treated with cisplatin, radiotherapy and erlotinib (erlotinib hydrochloride) versus cisplatin and radiotherapy alone.
SECONDARY OBJECTIVES:
- Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.
II. Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.
III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control.
IV. Correlate epidermal growth factor receptor (EGFR), p16 and excision repair cross-complementing 1 (ERCC-1) expression with response outcome to therapy with cisplatin and radiation with and without erlotinib.
- Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck (SCCHN) or response to therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cisplatin intravenously (IV) on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days -7 to 47.
ARM II: Patients receive cisplatin and undergo radiotherapy as in Arm I.
Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at the time of screening undergo a neck dissection.
After completion of study treatment, patients are followed up periodically for 5 years.
- Conditions
- Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Being tested
- erlotinib hydrochloride, cisplatin, 3-dimensional conformal radiation therapy, intensity-modulated radiation therapy, quality-of-life assessment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called CP-358,774, erlotinib, OSI-774
Given orally
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
3-dimensional conformal radiation therapyRadiation
Also called 3D-CRT, conformal radiation therapy
35 fractions
intensity-modulated radiation therapyRadiation
Also called IMRT
35 fractions
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer) | Experimental | Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride PO once daily on days -7 to 47. Receives: Drug: erlotinib hydrochloride; Drug: cisplatin; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy; Procedure: quality-of-life assessment |
| Arm II (chemotherapy, radiotherapy) | Active comparator | Patients receive cisplatin and radiotherapy as in Arm I. Receives: Drug: cisplatin; Radiation: 3-dimensional conformal radiation therapy; Radiation: intensity-modulated radiation therapy; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
Measured: 12 weeks after the completion of therapy
Secondary outcomes (2)
Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
Measured: 30 days after the completion of therapy
Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Every 3 months for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2012
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 Stage III Squamous Cell Carcinoma of the HypopharynxStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Renato Martins, Fred Hutchinson Cancer Center
- Investigators
- Renato Martins, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410826
- Sponsor's protocol ID
- 6106
- Other IDs
- NCI-2009-01546
- Status last verified
- May 2013
- First submitted
- 11 Dec 2006
- Last updated
- 10 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
PubMed 25057165Bauman JE, Austin MC, Schmidt R, Kurland BF, Vaezi A, Hayes DN, Mendez E, Parvathaneni U, Chai X, Sampath S, Martins RG. ERCC1 is a prognostic biomarker in locally advanced head and neck cancer: results from a randomised, phase II trial. Br J Cancer. 2013 Oct 15;109(8):2096-105. doi: 10.1038/bjc.2013.576. Epub 2013 Sep 24.
PubMed 24064970Martins RG, Parvathaneni U, Bauman JE, Sharma AK, Raez LE, Papagikos MA, Yunus F, Kurland BF, Eaton KD, Liao JJ, Mendez E, Futran N, Wang DX, Chai X, Wallace SG, Austin M, Schmidt R, Hayes DN. Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomized phase II trial. J Clin Oncol. 2013 Apr 10;31(11):1415-21. doi: 10.1200/JCO.2012.46.3299. Epub 2013 Mar 4.
PubMed 23460709
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00410826
- Acronym / sponsor ID
- 6106
- Conditions
- Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Nasopharynx, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- May 2012 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Posted 2 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells. It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer
Detailed description
PRIMARY OBJECTIVES:
- Compare the complete response rate in patients with locally advanced head and neck cancer, treated with cisplatin, radiotherapy and erlotinib (erlotinib hydrochloride) versus cisplatin and radiotherapy alone.
SECONDARY OBJECTIVES:
- Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.
II. Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.
III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control.
IV. Correlate epidermal growth factor receptor (EGFR), p16 and excision repair cross-complementing 1 (ERCC-1) expression with response outcome to therapy with cisplatin and radiation with and without erlotinib.
- Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck (SCCHN) or response to therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cisplatin intravenously (IV) on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days -7 to 47.
ARM II: Patients receive cisplatin and undergo radiotherapy as in Arm I.
Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at the time of screening undergo a neck dissection.
After completion of study treatment, patients are followed up periodically for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer) | Experimental | Drug: erlotinib hydrochloride, Drug: cisplatin, Radiation: 3-dimensional conformal radiation therapy, Radiation: intensity-modulated radiation therapy, Procedure: quality-of-life assessmentPatients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47. Patients also receive erlotinib hydrochloride PO once daily on days -7 to 47. |
| Arm II (chemotherapy, radiotherapy) | Active comparator | Drug: cisplatin, Radiation: 3-dimensional conformal radiation therapy, Radiation: intensity-modulated radiation therapy, Procedure: quality-of-life assessmentPatients receive cisplatin and radiotherapy as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx; patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the World Health Organization (WHO) classification
- Stage III or IV according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Sixth Edition (2002)
- Unresectable or resection with significant morbidity
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable Disease, defined according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Key exclusion criteria (10 listed)
- Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- Inability or unwillingness to comply with radiotherapy
- Evidence of clinically significant congestive heart failure; patients must be able to tolerate hydration required during cisplatin chemotherapy
- Diarrhea > grade 1 at the time of enrollment
- Prior radiotherapy, chemotherapy, or investigational treatment for squamous cell carcinoma of head and neck
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 |
|---|---|---|
| erlotinib hydrochlorideAlso: CP-358,774, erlotinib, OSI-774Given orally | Drug | Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer) |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) |
| 3-dimensional conformal radiation therapyAlso: 3D-CRT, conformal radiation therapy35 fractions | Radiation | Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) |
| intensity-modulated radiation therapyAlso: IMRT35 fractions | Radiation | Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (chemo, radiotherapy, enzyme inhibitor/radiosensitizer), Arm II (chemotherapy, radiotherapy) |
Primary outcome
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
Time frame: 12 weeks after the completion of therapy
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
2 secondary outcomes
Safety as Assessed Through Summaries of Adverse Events and Laboratory Test Results by Treatment Arm
Time frame: 30 days after the completion of therapy
Progression Free Survival of Patients With Locally Advanced Head and Neck Cancer Treated With Cisplatin and Radiotherapy, With and Without Erlotinib Hydrochloride
Time frame: Every 3 months for up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25057165Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.
- Derived from this study: PubMed 24064970Bauman JE, Austin MC, Schmidt R, Kurland BF, Vaezi A, Hayes DN, Mendez E, Parvathaneni U, Chai X, Sampath S, Martins RG. ERCC1 is a prognostic biomarker in locally advanced head and neck cancer: results from a randomised, phase II trial. Br J Cancer. 2013 Oct 15;109(8):2096-105. doi: 10.1038/bjc.2013.576. Epub 2013 Sep 24.
- Derived from this study: PubMed 23460709Martins RG, Parvathaneni U, Bauman JE, Sharma AK, Raez LE, Papagikos MA, Yunus F, Kurland BF, Eaton KD, Liao JJ, Mendez E, Futran N, Wang DX, Chai X, Wallace SG, Austin M, Schmidt R, Hayes DN. Cisplatin and radiotherapy with or without erlotinib in locally advanced squamous cell carcinoma of the head and neck: a randomized phase II trial. J Clin Oncol. 2013 Apr 10;31(11):1415-21. doi: 10.1200/JCO.2012.46.3299. Epub 2013 Mar 4.
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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.
Renato Martins principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
9 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 erlotinib hydrochloride, cisplatin and 3-dimensional conformal radiation therapy in people with Stage III Squamous Cell Carcinoma of the Hypopharynx and Stage III Squamous Cell Carcinoma of the Larynx, run by University of Washington at 9 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 13 inclusion and 10 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 10 May 2013. 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. 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 2 Apr 2013). 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?
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm (time frame: 12 weeks after the completion of therapy). 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 NCT00410826, 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 10 May 2013.