Hepatocellular CarcinomaPhase 2NCT00906373
A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver
A Phase 2 study testing IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg), IMC-A12 (cixutumumab) - 20 mg/kg and Sorafenib in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 7 sites in United States.
Trial summary
To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg), IMC-A12 (cixutumumab) - 20 mg/kg and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2009to May 2014
- 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
- The participant has histologically or cytologically confirmed, unresectable HCC
- The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
- The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
- The participant has fasting serum glucose <160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN) and/or hemoglobin A1C <7%. If baseline nonfasting glucose <160 mg/dL, fasting glucose measurement is not required
- The participant has the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- The participant has brain metastases
- The participant has acute hepatitis
- The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
- The participant has congestive heart failure > class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
ImClone Investigational Site
Burlington, Massachusetts, 01805
ImClone Investigational Site
Chicago, Illinois, 60611
ImClone Investigational Site
Los Angeles, California, 90095
ImClone Investigational Site
Metairie, Louisiana, 70006
ImClone Investigational Site
New York, New York, 10032
ImClone Investigational Site
Philadelphia, Pennsylvania, 19104
ImClone Investigational Site
Scottsdale, Arizona, 85259
About this study
Official title: A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)
To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer.
Read the detailed description
The purpose of this study is to determine progression-free survival (PFS) in participants with unresectable hepatocellular carcinoma who have received no prior systemic therapy when treated with IMC-A12 administered every three weeks in combination with oral sorafenib administered twice daily.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg), IMC-A12 (cixutumumab) - 20 mg/kg, Sorafenib
- Keywords
- Hepatocellular Carcinoma, Liver Neoplasms, Antibodies, Monoclonal
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)Biological
Also called cixutumumab, LY3012217
intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle
IMC-A12 (cixutumumab) - 20 mg/kgBiological
Also called cixutumumab, LY3012217
intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle
SorafenibDrug
400 milligrams (mg) twice per day orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, IMC A12 - 10 mg/kg | Active comparator | Treatment cycles will repeat until there is evidence of progressive disease (PD), toxicity, or withdrawal. If any participant experiences a dose-limiting toxicity (DLT), an additional 3 participants will be enrolled at this dose level (for a total of 6). If no further DLTs, enrollment into Cohort 2 will occur. Receives: Biological: IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg); Drug: Sorafenib |
| Cohort 2, IMC A12 20 - mg/kg | Active comparator | Treatment cycles will repeat until there is evidence of PD, toxicity, or withdrawal. Receives: Biological: IMC-A12 (cixutumumab) - 20 mg/kg; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.
Measured: Date of first dose of study drug up PD or death up to 12 months
Secondary outcomes (18)
Number of Participants With Adverse Events (AEs)
Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.
Measured: First day of treatment up to 22 months
Pharmacokinetic (PK): Maximum Concentration (Cmax) Cycle 1
Measured: Cycle 1, Day 1: Predose, 1 hour (h), 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Minimum Concentration (Cmin) Cycle 1
Measured: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Half-Life (t1/2) Cycle 1
Measured: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Clearance (CL) Cycle 1
Measured: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Area Under the Concentration Versus Time Curve (AUC) Cycle 1
Measured: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Volume of Distribution at Steady State (Vss) Cycle 1
Measured: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Cmax Cycle 3
Measured: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: Cmin Cycle 3
Measured: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: t1/2 Cycle 3
Measured: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: CL Cycle 3
Measured: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: AUC Cycle 3
Measured: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: Vss Cycle 3
Measured: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
Percentage of Participants With Complete Response (CR) and Partial Response (PR) [Objective Response Rate (ORR)]
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. CR was defined as the disappearance of all target and nontarget lesions and the normalization of tumor marker levels. PR was defined as having a ≥30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Participants who did not have a tumor response assessment for any reason were considered nonresponders and were included in the denominator when calculating the response rate. Percentage of participants was calculated as: CR + PR / total number of participants in the treatment group * 100.
Measured: Date of first dose of study drug to PD up to 12 months
Overall Survival (OS)
OS was defined as the time from the date of first dose of study drug to the date of death from any cause. If the participant was alive at the end of the follow-up period or was lost to follow-up, OS was censored on the last date the participant was known to be alive.
Measured: Date of first dose of study drug to date of death up to 22 months
Time to Disease Progression (TTP)
TTP is defined as the time from the date of first dose of study drug until the date of objective disease progression. Participants without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and lost to follow-up were censored at the date of the last objective tumor assessment before loss to follow-up. Participants who began new anticancer therapy prior to PD or death were censored at date of last tumor assessment prior to new therapy. Participants who died or had PD after ≥2 missed tumor assessments were censored at date of last tumor assessment prior to the missed assessments.
Measured: Date of first dose of study drug to date of PD up to 12 months
Duration of Response (DOR)
Duration of CR or PR was defined as time from first objective assessment of CR or PR until first date of PD or death from any cause. Response was defined using RECIST v 1.0 criteria. CR was defined as disappearance of all target and nontarget lesions and normalization of tumor marker levels. PR was defined as a ≥30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. PD defined as a ≥20% increase in the sum of LD of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants with no PD, who discontinued treatment for toxicity or a reason other than PD, or were lost to follow-up, were censored at date of last tumor assessment. Participants who began new anticancer therapy prior to PD or death were censored at date of last tumor assessment prior to new therapy. Participants who died or had PD after ≥2 missed tumor assessments were censored at date of last tumor assessment prior to the missed assessments
Measured: Date of first occurrence of CR or PR to first date of PD or death up to 8 months
The Number of Participants With Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)
A participant's serum sample was considered positive for antibodies against cixutumumab if it exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the anti-cixutumumab level seen in healthy untreated individuals. A participant was considered to have an anti-cixutumumab response if there were 2 consecutive positive samples or if the final sample tested was positive.
Measured: Predose, immediately prior to the first Cycle 3 and Cycle 5 infusions (3-week cycle) and 30 days after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2012
- Study completionMay 2014
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.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906373
- Sponsor's protocol ID
- 13931
- Other IDs
- CP13-0812, I5A-IE-JAEG
- Status last verified
- May 2018
- First submitted
- 20 May 2009
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 2 Study Evaluating IMC-A12 in Combination With Sorafenib as First-Line Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00906373
- Acronym / sponsor ID
- 13931
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Liver Neoplasms, Antibodies, Monoclonal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if IMC-A12 given in combination with Sorafenib is safe and effective for participants with advanced liver cancer.
Detailed description
The purpose of this study is to determine progression-free survival (PFS) in participants with unresectable hepatocellular carcinoma who have received no prior systemic therapy when treated with IMC-A12 administered every three weeks in combination with oral sorafenib administered twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, IMC A12 - 10 mg/kg | Active comparator | Biological: IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg), Drug: SorafenibTreatment cycles will repeat until there is evidence of progressive disease (PD), toxicity, or withdrawal. If any participant experiences a dose-limiting toxicity (DLT), an additional 3 participants will be enrolled at this dose level (for a total of 6). If no further DLTs, enrollment into Cohort 2 will occur. |
| Cohort 2, IMC A12 20 - mg/kg | Active comparator | Biological: IMC-A12 (cixutumumab) - 20 mg/kg, Drug: SorafenibTreatment cycles will repeat until there is evidence of PD, toxicity, or withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant has histologically or cytologically confirmed, unresectable HCC
- The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
- The participant has not received prior systemic therapy for HCC. Participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery
- The participant has fasting serum glucose <160 milligrams/deciliter (mg/dL) or below the upper limit of normal (ULN) and/or hemoglobin A1C <7%. If baseline nonfasting glucose <160 mg/dL, fasting glucose measurement is not required
- The participant has the ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (5 listed)
- The participant has brain metastases
- The participant has acute hepatitis
- The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition
- The participant has congestive heart failure > class II New York Heart Association (NYHA), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy
- The participant has experienced a hemorrhage or bleeding event ≥ National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 3 within 4 weeks prior first dose of study therapy
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 |
|---|---|---|
| IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg)Also: cixutumumab, LY3012217intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle | Biological | Cohort 1, IMC A12 - 10 mg/kg |
| IMC-A12 (cixutumumab) - 20 mg/kgAlso: cixutumumab, LY3012217intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle | Biological | Cohort 2, IMC A12 20 - mg/kg |
| Sorafenib400 milligrams (mg) twice per day orally | Drug | Cohort 1, IMC A12 - 10 mg/kg, Cohort 2, IMC A12 20 - mg/kg |
Primary outcome
Progression Free Survival (PFS)
Time frame: Date of first dose of study drug up PD or death up to 12 months
PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.
18 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: First day of treatment up to 22 months
Pharmacokinetic (PK): Maximum Concentration (Cmax) Cycle 1
Time frame: Cycle 1, Day 1: Predose, 1 hour (h), 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Minimum Concentration (Cmin) Cycle 1
Time frame: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Half-Life (t1/2) Cycle 1
Time frame: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Clearance (CL) Cycle 1
Time frame: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Area Under the Concentration Versus Time Curve (AUC) Cycle 1
Time frame: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Volume of Distribution at Steady State (Vss) Cycle 1
Time frame: Cycle 1, Day 1: Predose, 1 h, 2 h, 168 h, 336 h, and 504 h after start of infusion (immediately prior to Cycle 2)
PK: Cmax Cycle 3
Time frame: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: Cmin Cycle 3
Time frame: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: t1/2 Cycle 3
Time frame: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: CL Cycle 3
Time frame: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: AUC Cycle 3
Time frame: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
PK: Vss Cycle 3
Time frame: Cycle 3, Day 1: Predose, 2 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 504 h after start of infusion (immediately prior to Cycle 4)
Percentage of Participants With Complete Response (CR) and Partial Response (PR) [Objective Response Rate (ORR)]
Time frame: Date of first dose of study drug to PD up to 12 months
Overall Survival (OS)
Time frame: Date of first dose of study drug to date of death up to 22 months
Time to Disease Progression (TTP)
Time frame: Date of first dose of study drug to date of PD up to 12 months
Duration of Response (DOR)
Time frame: Date of first occurrence of CR or PR to first date of PD or death up to 8 months
The Number of Participants With Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)
Time frame: Predose, immediately prior to the first Cycle 3 and Cycle 5 infusions (3-week cycle) and 30 days after last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
7 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 IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg), IMC-A12 (cixutumumab) - 20 mg/kg and Sorafenib in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 7 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 5 inclusion and 5 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 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 4 Jun 2018). 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) (time frame: Date of first dose of study drug up PD or death up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2018.