Pancreatic CancerPhase 2NCT02581215
Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer
A Phase 2 study testing mFOLFIRINOX and Ramucirumab in people with Pancreatic Cancer, run by Walid Shaib, MD at 8 sites in United States.
Trial summary
This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- mFOLFIRINOX and Ramucirumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Sep 2016to 27 Jan 2022
- 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
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. .
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 7 days prior to registration.
- Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PCA) who present for first line chemotherapy treatment.
- No prior first line systemic treatment (prior adjuvant or neoadjuvant treatment is permitted). Subjects whose disease has progressed after 6 months of last systemic chemotherapy or chemo-radiation in the adjuvant or neoadjuvant setting are eligible.
- Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Baseline tumor assessment should be performed using high resolution computed tomography (CT) scans or magnetic resonance imaging (MRI).
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- Urine protein < 1+ on dipstick test or routine urinalysis. If the proteinuria on these tests is ≥2+, then a 24-hour urine test must be collected and must demonstrate < 1g proteins in 24 hours to allow participation.
- Estimated life expectancy of >12 weeks, as assessed by the site investigator.
- If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods) due to unknown risk of teratogenicity of ramucirumab
Who cannot join
- Subjects with histology other than adenocarcinoma; Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma or lymphoma of the pancreas.
- Ongoing or active infection.
- Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia. Symptomatic heart failure per New York Heart Association (NYHA) Class II-IV.
- Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management.
- Acute or sub-acute intestinal obstruction.
- Interstitial pneumonia or interstitial fibrosis of the lung, which in the opinion of the site investigator could compromise the subject or the study.
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- Pleural effusion or ascites that causes > grade 1 dyspnea.
- Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis; clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
- Grade 3 or higher bleeding event ≤ 3 months prior to randomization.
- Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, ≤ 6 months prior to randomization.
- History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to randomization.
- Documented and/or symptomatic or known brain or leptomeningeal metastases.
- GI perforation/fistula
- Documented and/or symptomatic or known brain or leptomeningeal metastases.
- Severely immune-compromised (other than being on steroids), including known HIV infection.
- Concurrent active malignancy other than adequately treated non-melanoma skin cancer, other noninvasive carcinoma, or in situ neoplasm. A subject with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years.
- Breast-feeding or pregnant.
- Prior autologous or allogeneic organ or tissue transplantation.
- Known allergy to any of the treatment components.
- Major surgery within 28 days prior to the first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 2 days prior to first dose of protocol therapy. The patient has elective or planned major surgery to be performed during the course of the clinical trial.
- Any condition that does not permit compliance with the study schedule including psychological, geographical or medical.
- Receiving medications that can effect clotting ability: warfarin, aspirin (once-daily aspirin use- maximum dose 325 mg/day is permitted), nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. .
- Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University: Winship Cancer Institute
Atlanta, Georgia, 30322
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Community Healthcare System
Munster, Indiana, 46321
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Thomas Jefferson University Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Mayo Clinic-Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Phase II Randomized, Double-Blind Study of mFOLFIRINOX Plus Ramucirumab Versus mFOLFIRINOX Plus Placebo in Advanced Pancreatic Cancer Patients: Hoosier Cancer Research Network GI14-198
This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.
Read the detailed description
OUTLINE: This is a multi-center study.
EXPERIMENTAL ARM A:
- Oxaliplatin 85 mg/m^2 over 2-4 hours
- Irinotecan 165 mg/m^2 over 90 minutes
- 5-FU 2,400 mg/m^2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
- Arm A will receive ramucirumab (RAM) administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
CONTROL ARM B :
- Oxaliplatin 85 mg/m2 over 2-4 hours
- Irinotecan 165 mg/m2 over 90 minutes
- 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
- Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were RAM.
In order to demonstrate adequate organ function, all screening labs must be obtained within 7 days prior to registration:
Hematological:
- Hemoglobin ≥ 9 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
- Platelet Count (PLT) ≥ 100,000/mm^3
Renal:
- Creatinine ≤ 1.5 mg/dL or Creatinine clearance^1 ≥ 40 mL/min
- Albumin ≥ 2.5 g/dL
Hepatic:
- Bilirubin ≤ 1.5 mg/dL
- Aspartate aminotransferase (AST) ≤ 3 × ULN or < 5 xULN in the setting of liver metastases
- Alanine aminotransferase (ALT) ≤ 3 × ULN or < 5 xULN in the setting of liver metastases
Coagulation:
- International Normalized Ratio (INR) (Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy) ≤1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x ULN
- Conditions
- Pancreatic Cancer
- Being tested
- mFOLFIRINOX, Ramucirumab, Placebo
- Keywords
- mFOLFIRINOX, Ramucirumab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFIRINOXDrug
mFOLFIRINOX:
- Oxaliplatin 85 mg/m2 over 2-4 hours
- Irinotecan 165 mg/m2 over 90 minutes
- 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
RamucirumabDrug
Also called Cyramza
Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
PlaceboOther
Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Experimental Arm | Experimental | mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks. Receives: Drug: mFOLFIRINOX; Drug: Ramucirumab |
| Arm B: Placebo Arm | Placebo comparator | mFOLFIRINOX will be administered every 2 weeks, and consist of:
* Oxaliplatin 85 mg/m2 over 2-4 hours
* Irinotecan 165 mg/m2 over 90 minutes
* 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
* Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab Receives: Drug: mFOLFIRINOX; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) at 9 Month
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
PFS is defined as time of registration until disease progression met by RECIST 1.1 or death from any cause.
Measured: 9 months
Secondary outcomes (3)
Overall Survival (OS)
Overall survival is defined by the date of randomization to date of death from any cause.
Measured: Up to a maximum of 53 months
Response Rate (RR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
Overall Response (OR) = CR + PR.
Measured: Up to 44 months
Number of Participants With Adverse Events
Adverse events will be assessed to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: From date of first dose until 30 days after the last treatment, assessed up to 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start11 Sep 2016
- Primary completion5 Aug 2021
- Study completion27 Jan 2022
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 (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid Shaib, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, Walid Shaib, MD, Hoosier Cancer Research Network
- Investigators
- Walid Shaib, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581215
- Sponsor's protocol ID
- HCRN GI14-198
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2015
- Last updated
- 1 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shaib WL, Manali R, Liu Y, El-Rayes B, Loehrer P, O'Neil B, Cohen S, Khair T, Robin E, Huyck T, Bekaii-Saab T. Phase II randomised, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients (HCRN GI14-198). Eur J Cancer. 2023 Aug;189:112847. doi: 10.1016/j.ejca.2023.02.030. Epub 2023 Mar 11.
PubMed 37268519
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double-Blind Study of mFOLFIRINOX Plus Ramucirumab Versus mFOLFIRINOX Plus Placebo in Advanced Pancreatic Cancer Patients: Hoosier Cancer Research Network GI14-198
- ClinicalTrials.gov ID
- NCT02581215
- Acronym / sponsor ID
- HCRN GI14-198
- Conditions
- Pancreatic Cancer
- Keywords
- mFOLFIRINOX, Ramucirumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Walid Shaib, MDUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Hoosier Cancer Research Network
- Study start
- 11 Sep 2016 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 1 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, multicenter, double-blinded, randomized, 2-arm trial evaluating the efficacy and safety of mFOLFIRINOX plus ramucirumab (Arm A) vs. mFOLFIRINOX plus placebo (Arm B) in 94 subjects with advanced pancreatic cancer, not amenable to curative treatment. Both arms will continue treatment until disease progression or unacceptable toxicity.
Detailed description
OUTLINE: This is a multi-center study.
EXPERIMENTAL ARM A:
- Oxaliplatin 85 mg/m^2 over 2-4 hours
- Irinotecan 165 mg/m^2 over 90 minutes
- 5-FU 2,400 mg/m^2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
- Arm A will receive ramucirumab (RAM) administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
CONTROL ARM B :
- Oxaliplatin 85 mg/m2 over 2-4 hours
- Irinotecan 165 mg/m2 over 90 minutes
- 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia.
- Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were RAM.
In order to demonstrate adequate organ function, all screening labs must be obtained within 7 days prior to registration:
Hematological:
- Hemoglobin ≥ 9 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3
- Platelet Count (PLT) ≥ 100,000/mm^3
Renal:
- Creatinine ≤ 1.5 mg/dL or Creatinine clearance^1 ≥ 40 mL/min
- Albumin ≥ 2.5 g/dL
Hepatic:
- Bilirubin ≤ 1.5 mg/dL
- Aspartate aminotransferase (AST) ≤ 3 × ULN or < 5 xULN in the setting of liver metastases
- Alanine aminotransferase (ALT) ≤ 3 × ULN or < 5 xULN in the setting of liver metastases
Coagulation:
- International Normalized Ratio (INR) (Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy) ≤1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x ULN
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Experimental Arm | Experimental | Drug: mFOLFIRINOX, Drug: RamucirumabmFOLFIRINOX will be administered every 2 weeks, and consist of: * Oxaliplatin 85 mg/m2 over 2-4 hours * Irinotecan 165 mg/m2 over 90 minutes * 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia. * Arm A will receive ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks. |
| Arm B: Placebo Arm | Placebo comparator | Drug: mFOLFIRINOX, Other: PlacebomFOLFIRINOX will be administered every 2 weeks, and consist of: * Oxaliplatin 85 mg/m2 over 2-4 hours * Irinotecan 165 mg/m2 over 90 minutes * 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia. * Arm B will receive a placebo infusion every 2 weeks. Due to the double-blinded nature of this study, the volume of placebo will be calculated as if it were ramucirumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information. .
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 7 days prior to registration.
- Histologic or cytological diagnosis of recurrent or metastatic pancreas adenocarcinoma (PCA) who present for first line chemotherapy treatment.
- No prior first line systemic treatment (prior adjuvant or neoadjuvant treatment is permitted). Subjects whose disease has progressed after 6 months of last systemic chemotherapy or chemo-radiation in the adjuvant or neoadjuvant setting are eligible.
Key exclusion criteria (23 listed)
- Subjects with histology other than adenocarcinoma; Examples include: neuroendocrine tumors, acinar cell cancer, sarcoma or lymphoma of the pancreas.
- Ongoing or active infection.
- Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia. Symptomatic heart failure per New York Heart Association (NYHA) Class II-IV.
- Uncontrolled or poorly-controlled hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) despite standard medical management.
- Acute or sub-acute intestinal obstruction.
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 |
|---|---|---|
| mFOLFIRINOXmFOLFIRINOX: * Oxaliplatin 85 mg/m2 over 2-4 hours * Irinotecan 165 mg/m2 over 90 minutes * 5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia. | Drug | Arm A: Experimental Arm, Arm B: Placebo Arm |
| RamucirumabAlso: CyramzaRamucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks. | Drug | Arm A: Experimental Arm |
| PlaceboPlacebo infusion with volume calculated as if it were ramucirumab every 2 weeks. | Other | Arm B: Placebo Arm |
Primary outcome
Progression Free Survival (PFS) at 9 Month
Time frame: 9 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time of registration until disease progression met by RECIST 1.1 or death from any cause.
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to a maximum of 53 months
Response Rate (RR)
Time frame: Up to 44 months
Number of Participants With Adverse Events
Time frame: From date of first dose until 30 days after the last treatment, assessed up to 44 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37268519Shaib WL, Manali R, Liu Y, El-Rayes B, Loehrer P, O'Neil B, Cohen S, Khair T, Robin E, Huyck T, Bekaii-Saab T. Phase II randomised, double-blind study of mFOLFIRINOX plus ramucirumab versus mFOLFIRINOX plus placebo in advanced pancreatic cancer patients (HCRN GI14-198). Eur J Cancer. 2023 Aug;189:112847. doi: 10.1016/j.ejca.2023.02.030. Epub 2023 Mar 11.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
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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.
Walid Shaib, MD principal investigator
Emory University
8 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 mFOLFIRINOX and Ramucirumab in people with Pancreatic Cancer, run by Walid Shaib, MD at 8 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 9 inclusion and 23 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 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 1 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) at 9 Month (time frame: 9 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 NCT02581215, 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 1 Jan 2025.