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Neoplasms, BreastPhase 2NCT00347919

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

A Phase 2 study testing pazopanib (GW786034) 400 mg, lapatinib (GW572016) 1500 mg and lapatinib (GW572016) 1000 mg in people with Neoplasms, Breast, run by GlaxoSmithKline at 84 sites in 16 countries.

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

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein. Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
pazopanib (GW786034) 400 mg, lapatinib (GW572016) 1500 mg and lapatinib (GW572016) 1000 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
84 sitesin 16 countries
Study dates
Jul 2006to Mar 2015
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 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for inclusion in this study only if all of the following criteria apply:
  • Women ≥ 18 years of age with a life expectancy of ≥ 12 weeks.
  • Note: National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association (ADRDA).)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Histologically confirmed invasive breast cancer with incurable stage IIIb, stage IIIc with T4 lesion, or stage IV disease at primary diagnosis or at relapse after curative-intent surgery.
  • No prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy for metastatic or recurrent disease (other than neoadjuvant or adjuvant therapy). Prior hormonal therapy (e.g., tamoxifen, raloxifen or an aromatase inhibitor) for advanced or metastatic disease is permitted provided at least 2 weeks have elapsed between the completion of the prior therapy and start of study drugs.
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  • Note: Subjects must have documented progressive disease (PD) or be intolerant to hormonal therapy. This must be documented in the source documentation.
  • Prior neoadjuvant therapy and/or adjuvant therapy is permitted.
  • Note:
  • (a) Subjects who have received both neoadjuvant and adjuvant therapies must have at least 6 months between completion of the chemotherapy-component of adjuvant therapy and start of study drug(s)
  • (b) Subjects who have received only adjuvant therapy must have at least 6 months between completion of the chemotherapy-component of adjuvant therapy and start of study drug(s)
  • (c) Subjects who have received only neoadjuvant therapy must have at least 6 months between completion of neoadjuvant therapy and start of study drug(s)
  • (d) Subjects who have received trastuzumab or hormonal agents as all or part of adjuvant therapy are eligible provided: (1) 2 weeks have elapsed since last dose (2) 6 months have elapsed between the start of trastuzumab or hormonal therapy and start of study drugs.
  • Radiotherapy prior to initiation of randomized therapy to a limited area (e.g., palliative treatment for painful disease) other than the sole site of measurable and assessable disease is allowed however, subjects must have completed treatment at least 4 weeks prior to starting study drugs, and must have recovered from all treatment-related toxicities prior to starting pazopanib and/or lapatinib.
  • Documented amplification of ErbB2 by Fluorescence In Situ Hybridization (FISH) in either the primary or metastatic tumor tissue. Archived tumor tissue must be provided for ErbB2 FISH testing by the central laboratory, which will be used to determine eligibility.
  • Note: Subjects that have documented ErbB2 amplification based on prior FISH testing or documented ErbB2 overexpression based on prior immunohistochemistry (IHC) with a value of 3+ are eligible, however, archived tumor tissue must be provided for confirmation by the central laboratory. If the results from prior testing are not confirmed by the central laboratory, then the subject can continue to receive study drug(s) at the discretion of the investigator, but will be excluded from the statistical analysis.
  • Archived tumor tissue (paraffin-embedded) must be available to correlate tumor response with intra-tumoral genetic changes as well as expression levels of relevant biomarkers. Results of biomarkers will not be used to determine subject eligibility for the study.
  • Ability to swallow and retain oral medication.
  • Disease must be measurable according to Response Evaluation Criteria in Solid Tumors (RECIST).
  • Subjects must have chosen treatment with lapatinib and/or pazopanib as initial treatment over other initial treatments (such as cytotoxic chemotherapy regimens or trastuzumab as a single agent) for locally advanced or metastatic disease.
  • Adequate organ function as defined below:
  • System (Laboratory Values)
  • Hematologic:Absolute neutrophil count (ANC) (≥1.5 X 109/L) Platelets (≥100 X 109/L)
  • Hepatic:Albumin(≥2.5 g/dL)Serum bilirubin(≤1.5 X upper limit of normal (ULN) unless due to Gilbert's syndrome) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (≤2.0 X ULN)
  • Renal:Calculated creatinine clearance1 (≥50 mL/min) Urine Protein2
  • (Negative, trace or +1 by dipstick urinalysis or <1.0 gram determined by 24 hour urine protein analysis).
  • A patient should first be screened with dipstick urinalysis. If urine protein by dipstick analysis is≥2+, then a 24-hour urine protein must be assessed and 24 hour urine protein must be <1 g protein to be eligible.
  • Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram. Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive or where MUGA scans are the accepted standard. Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure are not eligible.
  • A female is eligible to enter and participate in this study if she is of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Is post-menopausal (total cessation of menses for ≥1 year)
  • Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of study medication, and agrees to use adequate contraception during study participation and for a minimum of 2 menstrual cycles after the last dose of study medication. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
  • An intrauterine device with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the clinical trial, and for at least 2 menstrual cycles after the last dose of investigational product.
  • Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
  • Oral contraceptives are not reliable due to the potential drug-drug interactions.
  • Subjects must complete all screening assessments as outlined in the protocol.
  • Subjects must provide written informed consent prior to performance of any study-specific procedures or assessments and are willing to comply with treatment and follow-up.

Who cannot join

  • A subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Subjects with bilateral breast cancer or bone metastases as the only disease site.
  • Patients with high disease burden defined as >30% replacement of hepatic parenchyma with metastases, symptomatic pulmonary metastases (e.g., clinically significant dyspnea, cough, or chest pain attributable to pulmonary metastases), or >3 visceral organs with tumor involvement.
  • History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
  • Sarcoma histology.
  • Concurrent disease or condition that would make the subject inappropriate for study participation including (1) any unresolved or unstable, serious toxicity from prior administration of another investigational drug, (2) any serious medical disorder that would interfere with the subject's safety, obtaining informed consent or compliance to the study.
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  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for ³ 2 months prior to study enrollment. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
  • Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
  • Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
  • Presence of uncontrolled infection.
  • Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
  • Concurrent treatment with an investigational agent or participation in another clinical trial.
  • Use of an investigational anti-cancer drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of pazopanib and/or lapatinib.
  • Prior use of an investigational or licensed drug that targets either vascular endothelial growth factor (VEGF) or VEGF receptors, or ErbB2 (except for trastuzumab when used in the neo-adjuvant/adjuvant setting).
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.
  • Has taken/is taking prohibited medications, Lapatinib-related, orPazopanib-related.
  • Corrected QT interval (QTc) prolongation defined as QTc interval > 480 msecs.
  • History of any one of the following cardiac conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • History of cerebrovascular accident within the past 6 months.
  • Poorly controlled hypertension (systolic blood pressure (SBP) of ≥140mmHg, or diastolic blood pressure (DBP) of ≥90mmHg).
  • Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP/DBP values from both BP assessments must be < 140/90mmHg in order for a subject to be eligible for the study.
  • Presence of any non-healing wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.
  • Evidence of bleeding diathesis or coagulopathy.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.
  • Pregnant or lactating female.
  • Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis).

Trial locations and contacts

84 sites in 16 countries.

84 sites in 16 countries

United States19 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Alhambra, California, 91801

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Dallas, Texas, 75390-9113

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Henderson, Nevada, 89052

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90095-1752

  • GSK Investigational Site

    Lubbock, Texas, 79410

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Northridge, California, 91328

  • GSK Investigational Site

    Oxnard, California, 93030

  • GSK Investigational Site

    Redondo Beach, California, 90277

  • GSK Investigational Site

    San Antonio, Texas, 78207

  • GSK Investigational Site

    Santa Barbara, California, 93105

  • GSK Investigational Site

    Santa Maria, California, 93454

  • GSK Investigational Site

    The Bronx, New York, 10461

Other trials in United States

United Kingdom10 sites

  • GSK Investigational Site

    Birmingham, B15 2TH

  • GSK Investigational Site

    Chelmsford, Essex, CM1 7ET

  • GSK Investigational Site

    Glasgow, G12 OYN

  • GSK Investigational Site

    Ipswich, IP4 5PD

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    Manchester, Lancashire, M20 4BX

  • GSK Investigational Site

    Nottingham, NG5 1PB

  • GSK Investigational Site

    Plymouth, PL6 8DH

  • GSK Investigational Site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

France7 sites

  • GSK Investigational Site

    Besançon, 25030

  • GSK Investigational Site

    Hyères, 83400

  • GSK Investigational Site

    Lille, 59020

  • GSK Investigational Site

    Lyon, 69437

  • GSK Investigational Site

    Marseille Cedex BP 156, 13273

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Strasbourg, 67000

Other trials in France

India7 sites

  • GSK Investigational Site

    Bangalore, 560029

  • GSK Investigational Site

    Delhi, 110085

  • GSK Investigational Site

    Jaipur, 302004

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    Pune, 411 004

  • GSK Investigational Site

    Pune, 411001

  • GSK Investigational Site

    Trivandrum, 695011

Other trials in India

Israel6 sites

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Jerusalem, 91031

  • GSK Investigational Site

    Petah Tikva, 49100

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Rehovot, 76100

  • GSK Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Poland6 sites

  • GSK Investigational Site

    Elblag, 82-300

  • GSK Investigational Site

    Kielce, 25-640

  • GSK Investigational Site

    Krakow, 31-108

  • GSK Investigational Site

    Olsztyn, 10-226

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Warsaw, 02-781

Other trials in Poland

Pakistan5 sites

  • GSK Investigational Site

    Islamabad, 1590

  • GSK Investigational Site

    Karachi, 74800

  • GSK Investigational Site

    Lahore, 54000

  • GSK Investigational Site

    Lahore, 54600

  • GSK Investigational Site

    Multan, 60000

Other trials in Pakistan

Russia5 sites

  • GSK Investigational Site

    Moscow, 115 478

  • GSK Investigational Site

    Moscow, 117997

  • GSK Investigational Site

    Moscow, 129128

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

South Korea4 sites

  • GSK Investigational Site

    Incheon, 400-711

  • GSK Investigational Site

    Seodaemun-gu, Seoul, 120-752

  • GSK Investigational Site

    Songpa-gu, Seoul, 138-736

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-721

Other trials in South Korea

Canada3 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • GSK Investigational Site

    Weston, Ontario, M9N 1N8

Other trials in Canada

Hungary3 sites

  • GSK Investigational Site

    Budapest, 1082

  • GSK Investigational Site

    Budapest, 1122

  • GSK Investigational Site

    Győr, H-9024

Other trials in Hungary

Peru3 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Lima, Lima Province, Lima 11

  • GSK Investigational Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Malaysia2 sites

  • GSK Investigational Site

    Bandar Tun Razak, Cheras, 59100

  • GSK Investigational Site

    Petaling Jaya, 47400

Other trials in Malaysia

Mexico2 sites

  • GSK Investigational Site

    Mérida, Yucatán, 97500

  • GSK Investigational Site

    Mexico City, CP 14080

Other trials in Mexico

Singapore1 site

  • GSK Investigational Site

    Singapore, 169610

Other trials in Singapore

Thailand1 site

  • GSK Investigational Site

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: A Phase II, Open-Label, Randomized, Multicenter Trial of GW786034 (Pazopanib) in Combination With Lapatinib (GW572016) Compared to Lapatinib Alone as First Line Therapy in Subjects With Advanced or Metastatic Breast Cancer With ErbB2 Fluorescence In Situ Hybridization (FISH) Positive Tumors

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

Being tested
pazopanib (GW786034) 400 mg, lapatinib (GW572016) 1500 mg, lapatinib (GW572016) 1000 mg, pazopanib (GW786034) 800 mg
Keywords
GW786034, Quality of Life, GW572016, Lapatinib, Pazopanib, Metastatic, Breast cancer, Genetics, FISH, Advanced
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • pazopanib (GW786034) 400 mgDrug

    400 mg administered orally once daily

  • lapatinib (GW572016) 1500 mgDrug

    1500 mg administered orally once daily.

  • lapatinib (GW572016) 1000 mgDrug

    1000 mg administered orally once daily

  • pazopanib (GW786034) 800 mgDrug

    800 mg administered orally once daily

Study groups in NCT00347919
Study groupRoleWhat they receive
monotherapy armExperimental1500 mg (6 x 250 mg tablets) oral lapatinib once daily
Receives: Drug: lapatinib (GW572016) 1500 mg
Cohort 1 combination armExperimental1000 mg (4 x 250 mg tablets) of oral lapatinib and 400 mg (4 x 100 mg tablets) of oral pazopanib taken together once daily
Receives: Drug: pazopanib (GW786034) 400 mg; Drug: lapatinib (GW572016) 1000 mg
Cohort 2 combination armExperimental1500 mg (6 x 250 mg tablets) of oral lapatinib and 800 mg (1 x 500 mg tablets plus 3 x 100 mg tablets) of oral pazopanib taken together once daily
Receives: Drug: lapatinib (GW572016) 1500 mg; Drug: pazopanib (GW786034) 800 mg

What is being measured

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

  1. Percentage of Participants With Progressive Disease at Week 12 in Cohort 1

    The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a >=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.

    Measured: Week 12

Secondary outcomes (5)

  1. Overall Survival for Cohort 1

    Overall survival (OS) is defined as the time from randomization until death due to any cause. Participants who are alive as of the date of last contact are censored. There was insufficient follow-up to adequately assess OS for Cohort 2. Median OS cannot be presented for the lapatinib arm because the upper bound of the 95% confidence interval is undefined due to insufficient follow-up.

    Measured: Randomization until death due to any cause (up to 106.43 weeks)

  2. Response at Week 12 for Cohort 1 and Cohort 2

    The percentage of participants achieving either a complete (CR) or partial (PR) tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) is presented. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Progressive disease (PD), a >=20% increase in target lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee. Participants with an unknown or missing response were treated as non-responders.

    Measured: Week 12

  3. Duration of Response in Cohort 1

    Duration of response is defined as the length of time from the time from the first observation of response until progression of disease or death. Duration of response depends on two things: (1) when response is counted as starting; (2) when response is counted as ending.There were insufficient data to adequately assess duration of response for Cohort 2. IRC, independent review committee. For participants who do not progress or die, duration of response was censored at the date of last adequate assessment.

    Measured: Time from first documented evidence of complete or partial response until the first documented sign of disease progression or death due to any cause (up to 106.71 weeks)

  4. Time to Response (Complete or Partial Response) in Cohort 1 and Cohort 2

    Time to response is defined as the time from randomization to the time of first documented evidence of a complete (CR) or partial response (PR). The time to response will depend on when the response is counted as starting. Per RECIST: CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the target dimensions of the target lesions taking as a reference the baseline sum.

    Measured: The time from randomization to the time of first documented evidence of complete or partial response (up to 81.14 weeks for Cohort 1 and 44.29 weeks for Cohort 2)

  5. Percentage of Participants With Progressive Disease at Week 12

    The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Participants were classified as having PD if their response at Week 12 was unknown or missing. Per Response Evaluation Criteria In Solid Tumors (RECIST), PD is defined as a >=20% increase in target lesions. IRC, independent review committee.

    Measured: Week 12

Timeline

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

  1. First posted4 Jul 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionAug 2008
  4. Study completionMar 2015

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
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00347919
Sponsor's protocol ID
VEG20007
Status last verified
Jan 2016
First submitted
30 Jun 2006
Last updated
25 Feb 2016
Data monitoring committee
No

Publications

  • Johnston SR, Gomez H, Stemmer SM, Richie M, Durante M, Pandite L, Goodman V, Slamon D. A randomized and open-label trial evaluating the addition of pazopanib to lapatinib as first-line therapy in patients with HER2-positive advanced breast cancer. Breast Cancer Res Treat. 2013 Feb;137(3):755-66. doi: 10.1007/s10549-012-2399-4. Epub 2013 Jan 3.

    PubMed 23283526

  • de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

    PubMed 23054212

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib (GW786034) 400 mg, lapatinib (GW572016) 1500 mg and lapatinib (GW572016) 1000 mg in people with Neoplasms, Breast, run by GlaxoSmithKline at 84 sites in 16 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 42 inclusion and 30 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, United Kingdom, France, India, Israel and 11 more countries. 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 21 Feb 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?

Percentage of Participants With Progressive Disease at Week 12 in Cohort 1 (time frame: Week 12). 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 NCT00347919, which also lists 2 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 25 Feb 2016.

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