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Prostate CancerPhase 2NCT00683475

A Study of IMC-A12 or Ramucirumab Plus Mitoxantrone and Prednisone in Prostate Cancer

A Phase 2 study testing IMC-A12, Mitoxantrone and Prednisone in people with Prostate Cancer, run by Eli Lilly and Company at 36 sites in United States.

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 purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
IMC-A12, Mitoxantrone and Prednisone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
36 sitesUnited States
Study dates
Aug 2008to Sep 2011
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has histologically-confirmed adenocarcinoma of the prostate
  • The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
  • The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
  • The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
  • The participant must have evidence of progressive disease defined as at least one of the following;
  • Progressive measurable disease: using conventional solid tumor criteria
Show all 17Show fewer
  • Bone scan progression: at least two new lesions on bone scan
  • Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
  • The participant has a PSA ≥ 2 ng/mL
  • The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
  • The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
  • The participant has adequate hematologic function (absolute neutrophil count [ANC]≥1500/uL, hemoglobin ≥9 g/dL, and platelets ≥100,000/uL)
  • The participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present)
  • The participant has adequate renal function (creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
  • The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
  • The participant has adequate coagulation function (an international normalized ratio [INR] ≤ 1.5 and a Partial Thromboplastin Time [PTT] ≤ 5 seconds above the ULN [unless on oral anticoagulant therapy]). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
  • The participant has a fasting serum glucose level of < 160 mg/dL, or below the ULN

Who cannot join

  • The participant has received more than one prior cytotoxic chemotherapy regimen for metastatic disease. (Participants who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.)
  • The participant has received prior therapy with mitoxantrone for advanced prostate cancer (prior adjuvant therapy with mitoxantrone is permitted)
  • The participant has a history of symptomatic congestive heart failure or has a pre-study echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) that is ≥ 10% below the LLN
  • The participant has received radiotherapy ≤ 21 days prior to first dose of IMC-A12 or Ramucirumab
  • The participant is receiving corticosteroids (dexamethasone, prednisone, or others) at a dose > 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
  • The participant has known or suspected brain or leptomeningeal metastases
Show all 35Show fewer
  • The participant has uncontrolled or poorly controlled hypertension
  • The participant has poorly controlled diabetes mellitus. Inclusion Criteria:
  • The participant has histologically-confirmed adenocarcinoma of the prostate
  • The participant has radiographic evidence of metastatic prostate cancer (stage M1 or D2)
  • The participant has prostate cancer unresponsive or refractory to hormone therapy (androgen-independent)
  • The participant has had disease progression (clinical or radiographic) while receiving docetaxel, or within 120 days of receiving docetaxel-based chemotherapy and in the opinion of the investigator is unlikely to derive significant benefit from additional docetaxel-based therapy, or was intolerant to therapy with this agent
  • The participant must have evidence of progressive disease defined as at least one of the following;
  • Progressive measurable disease: using conventional solid tumor criteria
  • Bone scan progression: at least two new lesions on bone scan
  • Increasing PSA: at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2
  • The participant has a PSA ≥ 2 ng/mL
  • The participant has prior surgical or medical castration with a serum testosterone of <50 ng/mL. If the method of castration is luteinizing hormone releasing level hormone (LHRH) agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment
  • The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2
  • The participant has adequate hematologic function (absolute neutrophil count [ANC]≥1500/uL, hemoglobin ≥9 g/dL, and platelets ≥100,000/uL)
  • The participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase [AST] and alanine transaminase [ALT]≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present)
  • The participant has adequate renal function (creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 40 mL/min)
  • The participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
  • The participant has adequate coagulation function (an international normalized ratio [INR] ≤ 1.5 and a partial thromboplastin time [PTT] ≤ 5 seconds above the ULN [unless on oral anticoagulant therapy]). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3)
  • The participant has a fasting serum glucose level of < 160 mg/dL, or below the ULN
  • The participant has received more than one prior cytotoxic chemotherapy regimen for metastatic disease. (Participants who have had a treatment break followed by a second docetaxel-based regimen with subsequent disease progression are eligible.)
  • The participant has received prior therapy with mitoxantrone for advanced prostate cancer (prior adjuvant therapy with mitoxantrone is permitted)
  • The participant has a history of symptomatic congestive heart failure or has a pre-study echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) that is ≥ 10% below the LLN
  • The participant has received radiotherapy ≤ 21 days prior to first dose of IMC-A12 or Ramucirumab
  • The participant is receiving corticosteroids (dexamethasone, prednisone, or others) at a dose > 5 mg prednisone orally (PO) two times per day (BID) or equivalent. Participants receiving corticosteroids at higher doses may be eligible if their corticosteroid therapy is tapered to study levels (prednisone 5 mg PO BID) prior to first dose of study medication, without concomitant clinical deterioration
  • The participant has known or suspected brain or leptomeningeal metastases
  • The participant has uncontrolled or poorly controlled hypertension
  • The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
  • The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness with a history of diabetes are allowed to participate, provided that their blood glucose is within normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary or therapeutic regimen for this condition
  • The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • ImClone Investigational Site

    Abilene, Texas, 79606

  • ImClone Investigational Site

    Ann Arbor, Michigan, 48109

  • ImClone Investigational Site

    Atlanta, Georgia, 30318

  • ImClone Investigational Site

    Billings, Montana, 59101

  • ImClone Investigational Site

    Boca Raton, Florida, 33486

  • ImClone Investigational Site

    Buffalo, New York, 14263

  • ImClone Investigational Site

    Cedar Rapids, Iowa, 52402

  • ImClone Investigational Site

    Chicago, Illinois, 60611

  • ImClone Investigational Site

    Chlcago, Illinois, 60637

  • ImClone Investigational Site

    Cleveland, Ohio, 44195

  • ImClone Investigational Site

    Dallas, Texas, 75246

  • ImClone Investigational Site

    Durham, North Carolina, 27710

  • ImClone Investigational Site

    East Setauket, New York, 11733

  • ImClone Investigational Site

    Evanston, Illinois, 60201

  • ImClone Investigational Site

    Greenville, South Carolina, 29605

  • ImClone Investigational Site

    Houston, Texas, 77030-4009

  • ImClone Investigational Site

    Houston, Texas, 77030

  • ImClone Investigational Site

    Knoxville, Tennessee, 37920

  • ImClone Investigational Site

    La Jolla, California, 92093

  • ImClone Investigational Site

    Madison, Wisconsin, 53792

  • ImClone Investigational Site

    Maryville, Illinois, 62062

  • ImClone Investigational Site

    Metairie, Louisiana, 70006

  • ImClone Investigational Site

    Nashville, Tennessee, 37203

  • ImClone Investigational Site

    New Haven, Connecticut, 06520

  • ImClone Investigational Site

    New York, New York, 10016

  • ImClone Investigational Site

    New York, New York, 10019

  • ImClone Investigational Site

    New York, New York, 10021

  • ImClone Investigational Site

    New York, New York, 10032

  • ImClone Investigational Site

    Philadelphia, Pennsylvania, 19111

  • ImClone Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • ImClone Investigational Site

    Port Saint Lucie, Florida, 34952

  • ImClone Investigational Site

    Rochester, Minnesota, 55905

  • ImClone Investigational Site

    Roseland, New Jersey, 07068

  • ImClone Investigational Site

    Seattle, Washington, 98104

  • ImClone Investigational Site

    Seattle, Washington, 98109

  • ImClone Investigational Site

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized Study of IMC-A12 or IMC-1121B Plus Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy

The purpose of this study is to determine whether IMC-A12 or IMC-1121B (ramucirumab) with Mitoxantrone and Prednisone is effective in the treatment of metastatic androgen- independent prostate cancer (APIC).

Read the detailed description

Prostate cancer is the most frequently diagnosed cancer in men and the second leading cause of cancer-related death in men in the United States. Chemotherapy, either as a single agent or in combination, may lead to clinical response, pain control, and/or improved quality of life. Docetaxel is now the first-line standard therapy for AIPC. Mitoxantrone was approved in 1996 for use in combination with corticosteroids as initial chemotherapy for pain related to advanced Hormone Refractory Prostate Cancer (HRPC). Hormonal manipulations and docetaxel-based chemotherapy are often effective in metastatic prostate cancer; however, disease becomes refractory to these interventions in the majority of men. Although mitoxantrone continues to be a significant agent in the treatment of HRPC, there exists a need for more efficacious therapy in docetaxel-refractory- AIPC. Because of the potential contribution of Insulin Like Growth Factor Receptor (IGF-IR) and VEGFR-2 mediated pathways in prostate cancer pathogenesis, it is hypothesized that each of these biological agents in combination with mitoxantrone and prednisone will result in clinically meaningful activity in AIPC. Therefore, ImClone plans to conduct a randomized Phase 2 trial to assess the safety and efficacy of IMC-A12 or IMC-1121B (ramucirumab) in combination with mitoxantrone and prednisone in participants with AIPC.

Conditions
Prostate Cancer
Being tested
IMC-A12, Mitoxantrone, Prednisone, IMC-1121B (ramucirumab)
Keywords
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • IMC-A12Biological

    Also called cixutumumab, LY3012217

    IMC-A12 is to be administered as an I.V. infusion, 6 mg/kg over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. IMC-A12 treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met.

  • MitoxantroneDrug

    Mitoxantrone is to be administered as an I.V. infusion, at 12 milligrams/square meter (mg/m^2) over 5-15 minutes on Day 1 during a 3-week (21-day) cycle. Mitoxantrone treatment is to be continued for a maximum of 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤ 144 mg/m^2) or until there is evidence of disease progression, death, or intolerable toxicity.

  • PrednisoneDrug

    Prednisone (5 mg) is to be self-administered PO BID, each day of the 21-day cycle.

  • IMC-1121B (ramucirumab)Biological

    Also called ramucirumab, IMC-1121B, LY3009806

    IMC-1121B (ramucirumab) is to be administered as an intravenous (IV) infusion, 6 milligrams/kilogram (mg/kg) over 1 hour on Days 1, 8, and 15 of each 3-week (21-day) cycle. Ramucirumab treatment is to continue until there is evidence of disease progression, death, intolerable toxicity, or other withdrawal criteria are met.

Study groups in NCT00683475
Study groupRoleWhat they receive
IMC-1121B (ramucirumab) + Mitoxantrone + PrednisoneExperimentalNot described
Receives: Drug: Mitoxantrone; Drug: Prednisone; Biological: IMC-1121B (ramucirumab)
IMC-A12 + Mitoxantrone + PrednisoneExperimentalNot described
Receives: Biological: IMC-A12; Drug: Mitoxantrone; Drug: Prednisone

What is being measured

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

  1. Composite Progression-free Survival (cPFS)

    Defined as the median time from randomization to the earliest of:

    1. Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);
    2. Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;
    3. New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)
    4. Symptomatic progression (for participants without measurable disease);
    5. Other clinical events attributable to prostate cancer that require major interventions; or
    6. Death from any cause

    Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.

    Measured: Randomization to composite progressive disease, up to 23.4 months

Secondary outcomes (16)

  1. Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

    Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section.

    Measured: Randomization to 36.3 months

  2. Time to Radiographic Evidence of Disease Progression

    Time between date of randomization and earliest date of radiographic progression defined as either:

    1. Tumor progression by RECIST;
    2. Evidence of progression by bone scan;
    3. New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).

    Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy.

    Measured: Randomization to date of radiographic progression, up to 36.3 months

  3. Prostate Specific Antigen (PSA) Response Rate

    PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline.

    Measured: Baseline up to data cut-off date (up to 36.3 months)

  4. Composite Progression-free Survival (cPFS) at 6-months

    Data presented are the percentage of participants without disease progression at 6 months.

    Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.

    Measured: 6 months

  5. Composite Progression-free Survival (cPFS) at 9-months

    Data presented are the percentage of participants without disease progression at 9 months.

    Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.

    Measured: 9 months

  6. Composite Progression-free Survival (cPFS) at 12-months

    Data presented are the percentage of participants without disease progression at 12 months.

    Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy.

    Measured: 12 months

  7. Overall Survival (OS)

    Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive.

    Measured: First dose to death due to any cause up to 36.3 months

  8. Objective Response Rate (ORR)

    Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.

    Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.

    Measured: Baseline to date of progressive disease or death up to 36.3 months

  9. Maximum Concentration (Cmax) at Study Day 1

    Maximum Concentration (Cmax) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 1

  10. Maximum Concentration (Cmax) at Study Day 15

    Maximum concentration (Cmax) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 15

  11. Maximum Concentration (Cmax) at Study Day 16

    Maximum concentration (Cmax) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 16

  12. Maximum Concentration (Cmax) at Study Day 30

    Maximum concentration (Cmax) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 30

  13. Minimum Concentration (Cmin) at Study Day 1

    Minimum concentration (Cmin) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 1

  14. Minimum Concentration (Cmin) at Study Day 15

    Minimum concentration (Cmin) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 15

  15. Minimum Concentration (Cmin) at Study Day 16

    Minimum concentration (Cmin) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 16

  16. Minimum Concentration (Cmin) at Study Day 30

    Minimum concentration (Cmin) of Ramucirumab.

    All samples were assayed 36 months post sample collection, which exceeds the established long-term serum stability period for ramucirumab. Therefore, concentration data were invalid and pharmacokinetic (PK) analyses could not be conducted.

    Measured: Day 30

Timeline

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

  1. First posted23 May 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionSep 2011
  4. Study completionSep 2011

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
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00683475
Sponsor's protocol ID
13924
Other IDs
CP18-0601, I4T-IE-JVBS
Status last verified
Oct 2014
First submitted
19 May 2008
Last updated
16 Oct 2014
Data monitoring committee
Yes

Publications

  • Hussain M, Rathkopf D, Liu G, Armstrong A, Kelly WK, Ferrari A, Hainsworth J, Joshi A, Hozak RR, Yang L, Schwartz JD, Higano CS. A randomised non-comparative phase II trial of cixutumumab (IMC-A12) or ramucirumab (IMC-1121B) plus mitoxantrone and prednisone in men with metastatic docetaxel-pretreated castration-resistant prostate cancer. Eur J Cancer. 2015 Sep;51(13):1714-24. doi: 10.1016/j.ejca.2015.05.019. Epub 2015 Jun 13.

    PubMed 26082390

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMC-A12, Mitoxantrone and Prednisone in people with Prostate Cancer, run by Eli Lilly and Company at 36 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 17 inclusion and 35 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 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 18 Jun 2014). 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?

Composite Progression-free Survival (cPFS) (time frame: Randomization to composite progressive disease, up to 23.4 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 NCT00683475, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.

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