Carcinoma, HepatocellularPhase 1NCT02323906
Safety and Efficacy Study of CC-122 Combined With Sorafenib for Primary Liver Cancer
A Phase 1 study testing CC-122 and Sorafenib in people with Carcinoma, Hepatocellular, run by Celgene at 8 sites in United States.
Trial summary
CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in combination with sorafenib for subjects with unresectable HCC who have received no prior systemic therapy for HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- CC-122 and Sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Jan 2015to 21 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject understands and voluntarily signs an informed consent document prior to conducting any study related assessments/procedures
- Subject is 18 years of age or more at the time of signing the Informed Consent Form
- Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma according to the American Association for the Study of Liver Diseases Guidelines.A biopsy performed at screening may serve as a diagnostic biopsy for subjects with radiographic diagnosis.
- Subject has unresectable stage B (intermediate), or C (advanced) Hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer staging.Stage B subjects must have progressed after, or are not eligible for curative resection, transplantation, embolic, or ablative therapies
- Subject has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1. Evaluable target lesions may not have been treated with local therapy; previously treated lesions may only be evaluated as target lesions if they are the only lesions available and have shown objective definite progression after prior treatment. Local therapy must have been completed at least four weeks prior to baseline tumor evaluation
- Satisfactory archival tumor biopsy tissue is retrieved, or new tumor biopsy is performed, prior to starting Cycle 1
Show all 38Show fewer
- Subject has life expectancy of more than 12 weeks
- Subject has Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Subject has Child-Pugh score of less than 7 (ie, class A or better) with neither encephalopathy nor clinically significant ascites (ascites requiring paracentesis within 3 months of signing the ICF is excluded). Child-Pugh status is calculated based on clinical findings and laboratory results during the screening period.
- Subject has the following laboratory parameters at screening:
- Adequate hematologic function including:
- Absolute Neutrophil Count of at least 1.5 x 109/L
- Platelets of at least 75,000 x 106/L
- Hemoglobin of at least 9 g/dL
- International Normalized Ratio of at least 1.7
- Adequate hepatic function including:
- Serum aspartate aminotransferase and alanine amino-transferase of at least 5 times the upper limit of normal
- Serum total bilirubin of at least 3 mg/dL
- Serum albumin of at least 2.8 g/dL Note: Laboratories in combination must still be Child Pugh score less than 7
- Other laboratory parameters:
- Serum creatinine of at least 1.5 times the upper limit of normal
- Potassium within normal range or corrected with supplements
- For subjects with known or suspected cirrhosis, esophagogastroduodenoscopy ) within 12 months of signing the informed consent form, showing no evidence of untreated varices or stigmata of active bleeding (such as active ulcer, visible vessel, or blood) is required.
- Subjects with history of upper GI bleeding must have an EGD of 3 months or less prior to signing the consent form confirming adequate prior endoscopic therapy (eg, no evidence of any untreated varices, recent or active bleeding, stigmata suggesting high risk for bleeding, active ulcer). Subjects with history/suspected esophageal varices must be on optimal medical management (eg, proton pump inhibitor and non-selective beta-blocker) per local institutional policy.
- Subject is able to adhere to the study visit schedule and other protocol requirements
- Pregnancy Prevention Risk Management Plan
- Females of childbearing potential must undergo pregnancy testing based on the frequency outlined in Pregnancy Prevention Risk Minimization Plan and pregnancy results must be negative.
- Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods as specified in Pregnancy Prevention Risk Minimization Plan.
- Complete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.
- Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
- Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with Female of Childbearing Potential as specified in Pregnancy Prevention Risk Minimization Plan.
- Males must agree not to donate semen or sperm for 3 months after last dose of CC-122.
- All subjects must:
- Understand that CC-122 could have a potential teratogenic risk.
- Agree to abstain from donating blood while taking CC-122 or sorafenib and following discontinuation of their use.
- Agree not to share either study drug with another person.
- Other than the subject, Female of Childbearing Potential and males able to father a child should not handle CC-122 or touch the capsules, unless gloves are worn.
- Be counseled about pregnancy precautions and risks of fetal exposure
Who cannot join
- 1. Subject has received previous systemic therapy for Hepatocellular carcinoma including sorafenib, chemotherapy and investigational agents 2. Subject has received any local anticancer therapy ≤ 4 weeks prior to baseline tumor evaluation 3. Subject has undergone major surgery within the last 4 weeks or minor surgery within the last 2 weeks prior to signing the Informed Consent Form or who have not recovered from surgery 4. Subject has received an investigational drug or therapy for disease other than Hepatocellular carcinoma within the last 4 weeks or 5 half-lives, whichever is shorter, prior to signing the Informed Consent Form 5. Subject has completed any radiation treatment less than 2 weeks prior to signing the Informed Consent Form 6. Subject has received the last dose of α-interferon, ribavirin, sofobuvir and/or other antiviral therapies for Hepatitis C Virus (HCV) less than 4 weeks prior to signing the Informed Consent Form 7. Subject has any clinically significant bleeding, including bleeding from esophageal/gastric varices within ≤ 3 months of signing the informed consent form, which required transfusion, surgical procedure or hospitalization. Esophageal varices should be treated according to local standard practice (eg, ligation or banding and procedure completed ≤ 3 months prior to signing the informed consent form). See Inclusion Criterion 10 8. Subjects requiring therapeutic anticoagulation with either warfarin or low molecular weight heparin. Low dose low molecular weight heparin for catheter maintenance are permitted 9. Subject has tumor invasion of stomach or duodenum 10. Subject has histologic proof of fibrolamellar carcinoma 11. Subjects with known symptomatic brain metastasis 12. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) malabsorption ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03) Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of either study drug 13. Subject has history of concurrent second cancers requiring active, ongoing systemic treatment. 14. Subject has a known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory) 15. Subject has peripheral neuropathy of at least NCI CTCAE Grade 2 16. Subject has a history of persistent skin rash of at least NCI CTCAE Grade 2 17. Subject has impaired cardiac function or clinically significant cardiac disease including any of the following:
- LVEF (left ventricular ejection fraction) of 45% or less as determined by MUGA (multi-gated acquisition) or ECHO (Echocardiogram)
- Complete left bundle branch or bifascicular block
- Congenital long QT syndrome
- Persistent or clinically meaningful ventricular arrhythmias
- QTcF greater than 460 msec on Screening ECG (mean of triplicate recordings)
Show all 10Show fewer
- Unstable angina pectoris or myocardial infarction less than 6 months prior to starting either study drug
- Uncontrolled hypertension (blood pressure greater than 140/90 mmHg on at least 2 measurements on sequential visits, despite blood pressure medication)
- Subjects with baseline blood pressure 140/90 mmHg are eligible but must have optimal medication for blood pressure management h. Troponin-T value more than the upper limit of normal or BNP greater than 100 pg/mL 18. Subject has acute or chronic active infectious disorders or uncontrolled nonmalignant illnesses whose control, in the opinion of the investigator, may be jeopardized by complications of this study therapy. Chronic hepatitis B and C virus (HBV and HCV) are excepted (ie, eligible for study); HBV requires antiviral therapy 19. Subject has undergone liver transplantation or other solid organ transplantation requiring immunosuppression 20. Subject is receiving chronic treatment with systemic corticosteroids or other potentially immunosuppressive agent. Intermittent topical or local injection of corticosteroids and oral/IV aldosterone or other mineralocorticoids is allowed 21. Subjects with history of non-healing wounds or ulcers, or bone fractures less than 3 months of a prior fracture 22. Subject is being treated with concomitant strong CYP3A4 inducers such as St. John's Wort, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital. The use of concomitant strong CYP3A4 inducers may decrease sorafenib plasma concentrations and must be avoided.
- 23. Subject is a female who is pregnant or is breast feeding 24. Subject is unwilling or unable to comply with the protocol, in the opinion of the investigator 25. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 26. Subject has any condition that confounds the ability to interpret data from the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Henry Ford Hospital
Detroit, Michigan, 48202
University of Florida College of Med
Gainesville, Florida, 32610-0277
Greenville Hospital System
Greenville, South Carolina, 29605
Indiana University Cancer Center
Indianapolis, Indiana, 46202-528
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
University of California San Francisco
San Francisco, California, 94115
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1b, Multi-Center, Open-Label, Dose Finding Study of CC-122 in Combination With Sorafenib in Subjects With Unresectable Hepatocellular Carcinoma
CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in combination with sorafenib for subjects with unresectable HCC who have received no prior systemic therapy for HCC. The dose escalation phase of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part of the study using the optimal combination dose regimen.
Read the detailed description
The primary objective of the study is to determine the safety and tolerability of CC-122 administered orally in combination with sorafenib, and to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D).
The secondary objective of the study is to determine the preliminary efficacy of CC-122 in combination with sorafenib, based on response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- CC-122, Sorafenib
- Keywords
- Hepatocellular, Carcinoma, Phase 1, CC-122, Sorafenib,, Nexavar, Unresectable Hepatocellular Carcinoma, Unresectable HCCAdvanced,, Hepatocellular Carcinoma, liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-122Drug
Investigational new drug
SorafenibDrug
Also called Nexavar
Kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| CC-122 + Fixed-dose Sorafenib | Experimental | A dose escalation and expansion clinical study of CC-122 in combination with sorafenib in subjects with unresectable HCC who have received no prior systemic therapy for HCC.
The dose escalation part of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part. Receives: Drug: CC-122; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Number of Participants with Adverse Events
Measured: Up to 3 years
Dose-Limiting Toxicity (DLT)
Number of participants with a DLT. A DLT is defined as a treatment-related AE(s) occurring in Cycle 1 (including predose assessments on Cycle 2 Day 1).
Measured: 28 Days
Secondary outcomes (6)
Overall Response Rate (ORR)
Percentage of subjects with complete response or partial response using Response Evaluation Criteria in Solid Tumor (RECIST 1.1).
Measured: Up to 4 years
Disease control rate (DCR)
Percentage of subjects with complete response, partial response or stable disease using Response Evaluation Criteria in Solid Tumor (RECIST 1.1).
Measured: Up to 4 years
Duration of response (DoR)
Duration from the time of measurement criteria are first met for complete response or partial response until tumor progression using RECIST 1.1 or death.
Measured: Up to 4 years
Progression-free survival
Number of participants who survive without tumor progression using RECIST 1.1and time from the first dose date until objective tumor progression or death, whichever occurs first.
Measured: Up to 4 years
Overall survival
Number of participants who survive and the time from the first dose to death with any cause.
Measured: Up to 4 years
Time to progression (TTP)
Number of participants who do not have tumor progression using RECIST 1.1 and the time from the first dose date until objective tumor progression
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study start16 Jan 2015
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Why it stopped: Slow enrollment and business decision. No safety concerns were identified for the study drugs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristen Hege, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323906
- Sponsor's protocol ID
- CC-122-HCC-001
- Status last verified
- Mar 2017
- First submitted
- 24 Nov 2014
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Multi-Center, Open-Label, Dose Finding Study of CC-122 in Combination With Sorafenib in Subjects With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02323906
- Acronym / sponsor ID
- CC-122-HCC-001
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular, Carcinoma, Phase 1, CC-122, Sorafenib,, Nexavar, Unresectable Hepatocellular Carcinoma, Unresectable HCCAdvanced,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and business decision. No safety concerns were identified for the study drugs.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2015 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CC-122-HCC-001 is a Phase 1b dose escalation and expansion clinical study of CC-122 in combination with sorafenib for subjects with unresectable HCC who have received no prior systemic therapy for HCC. The dose escalation phase of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part of the study using the optimal combination dose regimen.
Detailed description
The primary objective of the study is to determine the safety and tolerability of CC-122 administered orally in combination with sorafenib, and to define the non-tolerated dose (NTD), the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D).
The secondary objective of the study is to determine the preliminary efficacy of CC-122 in combination with sorafenib, based on response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CC-122 + Fixed-dose Sorafenib | Experimental | Drug: CC-122, Drug: SorafenibA dose escalation and expansion clinical study of CC-122 in combination with sorafenib in subjects with unresectable HCC who have received no prior systemic therapy for HCC. The dose escalation part of the study will explore several dose levels of CC-122 in combination with sorafenib, followed by an expansion part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Subject understands and voluntarily signs an informed consent document prior to conducting any study related assessments/procedures
- Subject is 18 years of age or more at the time of signing the Informed Consent Form
- Subject has a confirmed pathologic diagnosis of Hepatocellular carcinoma according to the American Association for the Study of Liver Diseases Guidelines.A biopsy performed at screening may serve as a diagnostic biopsy for subjects with radiographic diagnosis.
- Subject has unresectable stage B (intermediate), or C (advanced) Hepatocellular carcinoma according to the Barcelona Clinic Liver Cancer staging.Stage B subjects must have progressed after, or are not eligible for curative resection, transplantation, embolic, or ablative therapies
- Subject has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1. Evaluable target lesions may not have been treated with local therapy; previously treated lesions may only be evaluated as target lesions if they are the only lesions available and have shown objective definite progression after prior treatment. Local therapy must have been completed at least four weeks prior to baseline tumor evaluation
Key exclusion criteria (10 listed)
- 1. Subject has received previous systemic therapy for Hepatocellular carcinoma including sorafenib, chemotherapy and investigational agents 2. Subject has received any local anticancer therapy ≤ 4 weeks prior to baseline tumor evaluation 3. Subject has undergone major surgery within the last 4 weeks or minor surgery within the last 2 weeks prior to signing the Informed Consent Form or who have not recovered from surgery 4. Subject has received an investigational drug or therapy for disease other than Hepatocellular carcinoma within the last 4 weeks or 5 half-lives, whichever is shorter, prior to signing the Informed Consent Form 5. Subject has completed any radiation treatment less than 2 weeks prior to signing the Informed Consent Form 6. Subject has received the last dose of α-interferon, ribavirin, sofobuvir and/or other antiviral therapies for Hepatitis C Virus (HCV) less than 4 weeks prior to signing the Informed Consent Form 7. Subject has any clinically significant bleeding, including bleeding from esophageal/gastric varices within ≤ 3 months of signing the informed consent form, which required transfusion, surgical procedure or hospitalization. Esophageal varices should be treated according to local standard practice (eg, ligation or banding and procedure completed ≤ 3 months prior to signing the informed consent form). See Inclusion Criterion 10 8. Subjects requiring therapeutic anticoagulation with either warfarin or low molecular weight heparin. Low dose low molecular weight heparin for catheter maintenance are permitted 9. Subject has tumor invasion of stomach or duodenum 10. Subject has histologic proof of fibrolamellar carcinoma 11. Subjects with known symptomatic brain metastasis 12. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) malabsorption ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03) Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of either study drug 13. Subject has history of concurrent second cancers requiring active, ongoing systemic treatment. 14. Subject has a known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory) 15. Subject has peripheral neuropathy of at least NCI CTCAE Grade 2 16. Subject has a history of persistent skin rash of at least NCI CTCAE Grade 2 17. Subject has impaired cardiac function or clinically significant cardiac disease including any of the following:
- Subjects with baseline blood pressure 140/90 mmHg are eligible but must have optimal medication for blood pressure management h. Troponin-T value more than the upper limit of normal or BNP greater than 100 pg/mL 18. Subject has acute or chronic active infectious disorders or uncontrolled nonmalignant illnesses whose control, in the opinion of the investigator, may be jeopardized by complications of this study therapy. Chronic hepatitis B and C virus (HBV and HCV) are excepted (ie, eligible for study); HBV requires antiviral therapy 19. Subject has undergone liver transplantation or other solid organ transplantation requiring immunosuppression 20. Subject is receiving chronic treatment with systemic corticosteroids or other potentially immunosuppressive agent. Intermittent topical or local injection of corticosteroids and oral/IV aldosterone or other mineralocorticoids is allowed 21. Subjects with history of non-healing wounds or ulcers, or bone fractures less than 3 months of a prior fracture 22. Subject is being treated with concomitant strong CYP3A4 inducers such as St. John's Wort, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital. The use of concomitant strong CYP3A4 inducers may decrease sorafenib plasma concentrations and must be avoided.
- 23. Subject is a female who is pregnant or is breast feeding 24. Subject is unwilling or unable to comply with the protocol, in the opinion of the investigator 25. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 26. Subject has any condition that confounds the ability to interpret data from the study
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 |
|---|---|---|
| CC-122Investigational new drug | Drug | CC-122 + Fixed-dose Sorafenib |
| SorafenibAlso: NexavarKinase inhibitor | Drug | CC-122 + Fixed-dose Sorafenib |
Primary outcome
Adverse Event
Time frame: Up to 3 years
Number of Participants with Adverse Events
Dose-Limiting Toxicity (DLT)
Time frame: 28 Days
Number of participants with a DLT. A DLT is defined as a treatment-related AE(s) occurring in Cycle 1 (including predose assessments on Cycle 2 Day 1).
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 4 years
Disease control rate (DCR)
Time frame: Up to 4 years
Duration of response (DoR)
Time frame: Up to 4 years
Progression-free survival
Time frame: Up to 4 years
Overall survival
Time frame: Up to 4 years
Time to progression (TTP)
Time frame: Up to 4 years
Results and safety
The study was stopped early (reason given: Slow enrollment and business decision. No safety concerns were identified for the study drugs.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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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.
Kristen Hege, MD study director
Celgene Corporation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-122 and Sorafenib in people with Carcinoma, Hepatocellular, run by Celgene 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 38 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Mar 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment and business decision. No safety concerns were identified for the study drugs.). Results are not available in the source record.
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?
Adverse Event (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 20 Mar 2017.