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Thyroid CarcinomaPhase 2NCT01813136

Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma

A Phase 2 study testing Continuous pazopanib (Arm A) and Intermittent pazopanib (Arm B) in people with Thyroid Carcinoma, run by Centre Leon Berard at 13 sites in France.

Completed

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

Official record
Search all trials

Trial summary

The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Carcinoma
What is being tested?
Continuous pazopanib (Arm A) and Intermittent pazopanib (Arm B)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
13 sitesFrance
Study dates
Mar 2013to Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age ≥ 18 years old,
  • Histologically confirmed diagnosis of differentiated thyroid cancer (papillary, follicular and poorly differentiated)
  • Archival tumor sample available. It will be provided for all subjects, for biomarker analysis before and/or during study treatment.
  • Patients must have been treated with therapeutic RAI. Patients may have received prior treatment with either 1 line of chemotherapy and/or up to 1 Tyrosine Kinase Inhibitor,
  • Resistance to therapeutic radioiodine (RAI) (for DTC) as demonstrated at least by one of the following:
  • Absence of iodine uptake in at least one target lesion on a post-therapy radioactive iodine scan,
Show all 30Show fewer
  • Presence of a target lesion after a cumulative radio-iodine activity of at least 600 mCi,
  • Patient with uptake who have RAI treatment of at least 100 mCi within the last 12 months and have disease progression,
  • Documented progression as per RECIST 1.1 based on 2 consecutives imaging performed within the last 12 months,
  • Measurable disease according to RECIST version 1.1,
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1,
  • Adequate organ system function defined as the following:
  • Hematology:
  • Absolute Neutrophils Count (ANC) ≥ 1.5 Gi/L
  • Hemoglobin ≥ 9 g/dL (5.6µM) (transfusion is not allowed within 7 days of screening assessments)
  • Platelets ≥ 100 Gi/L
  • Prothrombin Time (PT) ≤ 1.2 x ULN or International Normalized Ratio (INR) ≤ 1.2 Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired target of anticoagulation
  • Activated Partial Thromboplastin Time (aPTT) ≤ 1.2 x ULN
  • Electrolytes :
  • Potassium within normal ranges.
  • Hepatic :
  • Total bilirubin ≤ 1.5 x ULN
  • Alanine AminoTansferase (ALAT) and Aspartate AminoTransferase (ASAT) ≤ 2.5 x ULN Concomitant elevation in bilirubin and ASAT/ALAT above 1.0xULN is not allowed
  • Renal :
  • Serum creatinine ≤ 1.5 mg/dL (133µM) or if serum creatinine> 1.5 mg/dL, calculated creatinine clearance (ClCR) ≥ 50 mL/min (Cockcroft formula or MDRD formula for patients older than 65 years old)
  • Urine Protein to Creatinine Ratio (UPC) < 1; If UPC ratio ≥ 1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value < 1 gram to be eligible Use of urine dipstick for renal function assessment is not acceptable
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days of first dose of pazopanib. They must be willing to use effective contraception methods during the study and up to 7 days after the last pazopanib administration.
  • Affiliated to the French social security system.
  • Subjects must provide written informed consent prior to perform any study-specific procedure or assessment and must be willing to comply with treatment and follow up.
  • Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study such as bone scan) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol,

Who cannot join

  • Other histological sub-types of thyroid tumors like medullar carcinoma, anaplastic carcinoma, lymphoma or sarcoma,
  • Prior treatment with pazopanib,
  • Prior malignancy, Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
  • Symptomatic metastases of Central nervous system (CNS) requiring or having required steroids or enzyme-inducing anticonvulsants within 4 weeks before inclusion ,
  • Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
  • Active peptic ulcer disease,
Show all 36Show fewer
  • Known intraluminal metastatic lesion with risk of bleeding,
  • Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation,
  • History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to begin study treatment,
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
  • Malabsorption syndrome,
  • Major resection of the stomach or small bowel,
  • Corrected QT interval (QTc) > 480 msec (correction method according to the Bazett's method),
  • History of any one or more of the following cardiovascular conditions within the past 6 months :
  • Cardiac angioplasty or stenting,
  • Myocardial infarction,
  • Unstable angina,
  • Coronary artery bypass graft surgery,
  • Symptomatic peripheral vascular disease,
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA),
  • Cerebrovascular accident including Transient Ischemic Attack (TIA), pulmonary embolism or untreated Deep Venous Thrombosis (DVT), Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible,
  • Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) as described in the section 7.2 "Study requirements" of this protocol, Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. At least one day after antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. These three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be <140/90 mmHg (OR 150/90 mm Hg, if this criterion is approved by the coordination center) in order to be eligible.
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement are not considered to be major surgery),
  • Evidence of active bleeding or bleeding diathesis,
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage, Lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
  • Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed.
  • Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed.
  • Hemoptysis within the last 8 weeks before inclusion,
  • Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drug,
  • Treatment with any of the following anti-cancer therapies :
  • radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib (analgesic radiation therapy is allowed if the radiation field doesn't include a potential target lesion for tumor assessments),
  • chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib,
  • Administration of other oncologic drug or any non-oncologic investigational drug within 30 days (or 5 half lives whichever is longer) prior to receiving the first dose of study treatment, or planned to be administered during the study participation,
  • Unable or unwilling to discontinue use of prohibited medications listed in Section 6.2.4.c "Prohibited medications" for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study,
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity (according to the NCI-CTC AE v4.0), except alopecia,
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • CHU Angers

    Angers, 49933

  • CHU Bordeaux

    Bordeaux, 33075

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • CHRU Lille Hôpital Claude Huriez

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69373

  • Hôpital de la Timone APHM

    Marseille, 13385

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hôpital Saint-Louis APHP

    Paris, 75010

  • Hôpital de la Pitié Salpêtrière APHP

    Paris, 75651

  • Institut Jean Godinot

    Reims, 51726

  • Institut Claudius Régaud

    Toulouse, 31052

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Randomized, Multicenter, Open-label, Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma

The objective of this study is to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive Differentiated Thyroid Cancer (DTC) patients as compared to pazopanib continuous administration.

Read the detailed description

Total or near-total thyroidectomy is the primary treatment for differentiated thyroid carcinoma. Postoperatively, DTC are treated with radioiodine (131I) and thyroid stimulating hormone (TSH) suppressive levothyroxine therapy.

But 5% to 20% of patients with DTC develop distant metastases; some of them become refractory to 131I therapy.

Targeted therapies have been studied in iodine refractory DTC for several years but none of these treatments has yet been approved in DTC and clinicians continue to enroll patients in clinical trials. The agents used so far in thyroid cancer are small molecules sharing the property to inhibit various tyrosine kinase receptors such as Vascular Endothelial Growth Factor Receptor (VEGFR), Epidermal Growth Factor Receptor (EGFR), RET or c-met.

The VEGF (Vascular Endothelial Growth Factor) is one of the several pro angiogenic molecules that play a pivotal role in angiogenesis, one of the mechanisms involved in tumor growth and dissemination.

VEGF expression is highly prevalent in Papillary Thyroid Carcinoma (PTCs) (79%), Follicular Thyroid Carcinoma (FTCs) (50%) or Poorly Differentiated Thyroid Carcinoma (PDTCs) (37%) and VEGFR is respectively expressed in 76%, 83% and 25% for VEGRF-1 and 68%, 56% and 37% for VEGRF-2.

Pazopanib (GW786034 - GlaxoSmithKline) is an orally administered, potent multitarget tyrosine kinase inhibitor of VEGFR in particular (but also of PDGFR-α and -β, and stem cell factor receptor c-Kit).

The results obtained in metastatic or locally advanced refractory DTC are currently available (phase II study of 39 patients with metastatic, rapidly progressive RAI-refractory DTC, treated with pazopanib 800mg daily, were published in Lancet Oncology in 2010 by KC Bible), demonstrating the efficacy of these therapies in this indication. However, no clear data is yet available indicating the optimal duration of treatment in first line therapy: patients are currently treated until progression or until drug discontinuation due to toxicity. Indeed, patients may have some difficulties to manage the chronic mild to moderate (grade 1-2) side-effects related to long-term treatment, leading some asymptomatic patients in whom tumor is controlled by TKI treatment to ask for treatment interruption.

The intermittent administration should avoid the occurrence of long-term adverse event and subsequent dose reductions or discontinuation, thus allowing a longer control of underlying disease.

All these considerations led our reflexion in the design of the present study, that is to say to determine the feasibility of pazopanib treatment interruption with reintroduction at progression in iodine refractory progressive DTC patients as compared to pazopanib continuous administration, after 6 initial cycles of pazopanib 800 mg daily for all patients included in the study, with a strong rationale for intermittent administration of pazopanib.

Being tested
Continuous pazopanib (Arm A), Intermittent pazopanib (Arm B)
Keywords
radioiodine refractory Differentiated Thyroid Carcinoma, pazopanib, intermittent administration, time to treatment failure, TUTHYREF
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • Continuous pazopanib (Arm A)Drug

    Also called GW786034

    Daily oral administration of pazopanib 800mg (28 days cycles) from randomization until progression (according to RECIST 1.1) under treatment, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization

  • Intermittent pazopanib (Arm B)Drug

    Also called GW786034

    Temporary discontinuation of pazopanib at randomization, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization. Pazopanib will be reintroduced for 6 cycles of 28 days, with daily administration of pazopanib 800mg, as soon as the patient relapses (progressive disease according to RECIST 1.1). At the end of this additional 6 cycles, study drug will be stopped a second time.

    This sequential scheme will be maintained until the patient experiences "on-treatment" progression

Study groups in NCT01813136
Study groupRoleWhat they receive
Continuous pazopanib (Arm A)Active comparatorDaily oral administration of pazopanib 800mg (28 days cycles) from randomization until progression (according to RECIST 1.1) under treatment, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization
Receives: Drug: Continuous pazopanib (Arm A)
Intermittent pazopanib (Arm B)ExperimentalTemporary discontinuation of pazopanib at randomization, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization. Pazopanib will be reintroduced for 6 cycles of 28 days, with daily administration of pazopanib 800mg, as soon as the patient relapses (progressive disease according to RECIST 1.1). At the end of this additional 6 cycles, study drug will be stopped a second time. This sequential scheme will be maintained until the patient experiences "on-treatment" progression
Receives: Drug: Intermittent pazopanib (Arm B)

What is being measured

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

  1. Time to treatment failure (TTF)

    TTF is the time to permanent treatment discontinuation due to any cause after randomization in each arm

    Measured: up to 36 months

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    Proportion of patients with a best overall response of Complete Response (CR) or a Partial Response (PR) at the end of the first 6 cycles, according to RECIST criteria 1.1

    Measured: 6 months after inclusion

  2. Disease Control Rate (DCR)

    Proportion of patients with a best overall response of Complete Response, Partial Response or Stable Disease at the end of the first 6 cycles, according to RECIST criteria 1.1

    Measured: 6 months after inclusion

  3. Progression-Free Survival (PFS)

    Time from date of randomization to the date of event defined as the first documented progression under treatment or death due to any cause.

    Measured: up to 36 months

  4. Best response rate

    Best response observed from date of randomization

    Measured: up to 36 months

  5. Duration of response

    Time from the first documented response (CR or PR) to the first documented disease progression or death due to any cause, applies only to patients whose best overall response is CR or PR

    Measured: up to 36 months

  6. Overall Survival (OS)

    Time from date of randomization to the date of death due to any cause

    Measured: up to 36 months

  7. Objective Response Rate (ORR)

    Proportion of patients with a CR or a PR after 6 cycles from randomization.

    Measured: 6 months after randomization

  8. Disease Control Rate (SDR)

    The proportion of patients with a SD, PR or CR after 6 cycles from randomization.

    Measured: 6 months after randomization

  9. Safety profile of pazopanib

    Adverse events (AE) experienced throughout the study and assessed according the NCI-CTC AE version 4.0.

    Measured: up to 36 months

  10. Quality of Life (QoL)

    The score obtained at the EORTC Quality of Life Questionnaire C30

    Measured: At inclusion, randomization and at the end of pazopanib treatment

Timeline

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

  1. First posted18 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

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
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01813136
Sponsor's protocol ID
PAZOTHYR
Other IDs
2012-003162-41
Status last verified
Jul 2026
First submitted
11 Mar 2013
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Bible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM, Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. doi: 10.1016/S1470-2045(10)70203-5. Epub 2010 Sep 17.

    PubMed 20851682

  • Altorki N, Lane ME, Bauer T, Lee PC, Guarino MJ, Pass H, Felip E, Peylan-Ramu N, Gurpide A, Grannis FW, Mitchell JD, Tachdjian S, Swann RS, Huff A, Roychowdhury DF, Reeves A, Ottesen LH, Yankelevitz DF. Phase II proof-of-concept study of pazopanib monotherapy in treatment-naive patients with stage I/II resectable non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3131-7. doi: 10.1200/JCO.2009.23.9749. Epub 2010 Jun 1.

    PubMed 20516450

  • Billemont B, Medioni J, Taillade L, Helley D, Meric JB, Rixe O, Oudard S. Blood glucose levels in patients with metastatic renal cell carcinoma treated with sunitinib. Br J Cancer. 2008 Nov 4;99(9):1380-2. doi: 10.1038/sj.bjc.6604709. Epub 2008 Oct 7.

    PubMed 18841151

  • Borson-Chazot F, Bardet S, Bournaud C, Conte-Devolx B, Corone C, D'Herbomez M, Henry JF, Leenhardt L, Peix JL, Schlumberger M, Wemeau JL; Expert Group for French Recommendations for the Management of Differentiated Thyroid Carcinomas of Vesicular Origin; Baudin E, Berger N, Bernard MH, Calzada-Nocaudie M, Caron P, Catargi B, Chabrier G, Charrie A, Franc B, Hartl D, Helal B, Kerlan V, Kraimps JL, Leboulleux S, Le Clech G, Menegaux F, Orgiazzi J, Perie S, Raingeard I, Rodien P, Rohmer V, Sadoul JL, Schwartz C, Tenenbaum F, Toubert ME, Tramalloni J, Travagli JP, Vaudrey C. Guidelines for the management of differentiated thyroid carcinomas of vesicular origin. Ann Endocrinol (Paris). 2008 Dec;69(6):472-86. doi: 10.1016/j.ando.2008.10.002. No abstract available.

    PubMed 19137632

  • Brose M. S., et al. Effect of BRAFV600E on response to sorafenib in advanced thyroid cancer patients. J Clin Oncol (meeting Abstracts) 27.15S (2009) : 6002.

  • Carr LL, Mankoff DA, Goulart BH, Eaton KD, Capell PT, Kell EM, Bauman JE, Martins RG. Phase II study of daily sunitinib in FDG-PET-positive, iodine-refractory differentiated thyroid cancer and metastatic medullary carcinoma of the thyroid with functional imaging correlation. Clin Cancer Res. 2010 Nov 1;16(21):5260-8. doi: 10.1158/1078-0432.CCR-10-0994. Epub 2010 Sep 16.

    PubMed 20847059

  • de la Fouchardiere C, Droz JP. Targeted therapies and thyroid cancer: an update. Anticancer Drugs. 2011 Aug;22(7):688-99. doi: 10.1097/CAD.0b013e32834319c7.

    PubMed 21200314

  • Fagin JA, Tuttle RM, Pfister DG. Harvesting the low-hanging fruit: kinase inhibitors for therapy of advanced medullary and nonmedullary thyroid cancer. J Clin Endocrinol Metab. 2010 Jun;95(6):2621-4. doi: 10.1210/jc.2010-0800. No abstract available.

    PubMed 20525911

  • GSK Laboratories. Investigator's Brochure of pazopanib, version 09 dated 25 Jan. 2012.Ref Type: Unpublished Work

  • Gupta-Abramson V, Troxel AB, Nellore A, Puttaswamy K, Redlinger M, Ransone K, Mandel SJ, Flaherty KT, Loevner LA, O'Dwyer PJ, Brose MS. Phase II trial of sorafenib in advanced thyroid cancer. J Clin Oncol. 2008 Oct 10;26(29):4714-9. doi: 10.1200/JCO.2008.16.3279. Epub 2008 Jun 9.

    PubMed 18541894

  • Hutson TE, Davis ID, Machiels JP, De Souza PL, Rottey S, Hong BF, Epstein RJ, Baker KL, McCann L, Crofts T, Pandite L, Figlin RA. Efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2010 Jan 20;28(3):475-80. doi: 10.1200/JCO.2008.21.6994. Epub 2009 Dec 14.

    PubMed 20008644

  • Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9. doi: 10.1002/sim.4780010204.

    PubMed 7187087

  • Jebreel A, England J, Bedford K, Murphy J, Karsai L, Atkin S. Vascular endothelial growth factor (VEGF), VEGF receptors expression and microvascular density in benign and malignant thyroid diseases. Int J Exp Pathol. 2007 Aug;88(4):271-7. doi: 10.1111/j.1365-2613.2007.00533.x.

    PubMed 17696908

  • Iwamoto FM, Lamborn KR, Robins HI, Mehta MP, Chang SM, Butowski NA, Deangelis LM, Abrey LE, Zhang WT, Prados MD, Fine HA. Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02). Neuro Oncol. 2010 Aug;12(8):855-61. doi: 10.1093/neuonc/noq025. Epub 2010 Mar 3.

    PubMed 20200024

  • Kaplan, E. L and P. Meier. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958): 457-81.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Continuous pazopanib (Arm A) and Intermittent pazopanib (Arm B) in people with Thyroid Carcinoma, run by Centre Leon Berard at 13 sites in France.

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 30 inclusion and 36 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to treatment failure (TTF) (time frame: up to 36 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 NCT01813136, which also lists 32 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 2 Jul 2026.

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