Advanced CancerPhase 1NCT01394016

A Phase 1 Study of LY2835219 In Participants With Advanced Cancer

A Phase 1 study testing Abemaciclib and Fulvestrant in people with Advanced Cancer, run by Eli Lilly and Company at 3 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 a safe dose of Abemaciclib to be given to participants with advanced cancer and to determine any side effects that may be associated with Abemaciclib in this population. Efficacy measures will be used to assess the activity of Abemaciclib in this population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Cancer
What is being tested?: Abemaciclib and Fulvestrant
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: 3 sitesUnited States
Study dates: 7 Dec 2009to 12 Apr 2022
Phase: Phase 1
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

For all Parts (Dose escalation and expansion): The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy either after available standard therapies have ceased to provide clinical benefit (Parts A, B, C, D, E and F) or in combination with fulvestrant (Part G only)
For Dose Escalation (Part A): The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic
For Dose Expansion (Parts B, C, D, E, F and G): The participant must have histological or cytological evidence of one of the following cancers:
Part B: Non-small cell lung cancer of any subtype that is advanced and/or metastatic
Part C: Glioblastoma multiforme that has progressed or recurred after radiotherapy and/or chemotherapy
Part D: Breast cancer that is advanced and/or metastatic

Show all 21Show fewer

Part E: Melanoma that is advanced and/or metastatic
Part F: Colorectal Cancer
Part G: Breast Cancer that is not only advanced and/or metastatic but also hormone receptor positive
As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma
For Parts A and G: Have measurable or nonmeasurable disease
For Parts B, C, D, E and F: Have measurable disease
Have given written informed consent prior to any study-specific procedures
Have adequate hematologic, hepatic, and renal function
Have a performance status less than or equal to 1 for Dose Escalation (Part A) and less than or equal to 2 for Dose Confirmation (Parts B, C, D, E, F and G) on the Eastern Cooperative Oncology Group (ECOG) scale
Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) with the exception of fulvestrant (for Part G only) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug
Females with child bearing potential must have a negative serum pregnancy test within 3 days of the first dose of study drug
Have an estimated life expectancy of greater than or equal to 12 weeks
Are able to swallow capsules

Who cannot join

Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), sudden cardiac death or sudden cardiac arrest
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)
For Dose Escalation (Part A): Have central nervous system (CNS) malignancy or metastasis
For Dose Confirmation (Parts B, D, E, F and G): Have CNS metastasis that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids
For Dose Confirmation (Part C): Have glioblastoma multiforme that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids

Show all 10Show fewer

Have an acute leukemia
Have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
Females who are pregnant or lactating
Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies) Screening is not required for enrollment

Trial locations and contacts

3 sites in 1 country.

United States3 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Boston, Massachusetts, 02115
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
San Antonio, Texas, 78229
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer

Conditions: Advanced Cancer
Being tested: Abemaciclib, Fulvestrant

What participants receive

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

AbemaciclibDrug
Also called LY2835219
Administered orally.
FulvestrantDrug
Fulvestrant is administered intramuscularly into the buttocks in Part G only.

Study groups in NCT01394016
Study group	Role	What they receive
Abemaciclib	Experimental	Participants received oral Abemaciclib administered on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as appropriate on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion. Participants belonging to different Parts received the study drug as specified below: Part A: 50 mg/100 mg/150 mg/225 mg every 24 hours (Q24H) or 75mg/100 mg/150 mg/200 mg/275 mg every 12 hours (Q12H). Parts B, C, D, and E: 150 mg/200 mg Q12H. Part F: 150 mg Q12H. Part G: 200 mg Q12H along with 500 mg Fulvestrant administered intramuscularly. Receives: Drug: Abemaciclib; Drug: Fulvestrant

What is being measured

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

Number of Participants With Clinically Significant Effects
The number of participants with clinically significant findings in the study were reported in this outcome measure.
Measured: Baseline up to 233 weeks

Secondary outcomes (4)

Percentage of Participants With Tumor Response - Overall Response Rate (ORR), Disease Control Rate (DCR)
ORR is the percentage of participants who exhibit a confirmed complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
DCR is defined as the percentage of participants in the analysis population who exhibit a stable disease (SD) or confirmed CR or PR relative to baseline during the study. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Measured: Baseline through Study Completion (Up to 285 weeks)
Pharmacokinetics (PK): Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib
PK: Cmax,ss of Abemaciclib.
Measured: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
PK: Area Under the Steady State Plasma Concentration-time Curve Over 24 Hours (AUC 0-24hr,ss) of Abemaciclib
PK: AUC 0-24hr,ss of Abemaciclib.
Measured: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
Part A: Recommended Dose for Phase 2 Studies
The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from the study.
Measured: Baseline through Study Completion (Up to 285 weeks)

Timeline

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

7 Dec 200912 Apr 2022

First posted14 Jul 2011 (estimated)
Study start7 Dec 2009
Primary completion29 May 2014
Study completion12 Apr 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 (2)Papers the sponsor has linked to this study.
Other trials for Advanced CancerStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01394016
Sponsor's protocol ID: 13199
Other IDs: I3Y-MC-JPBA
Status last verified: Sep 2024
First submitted: 12 Jul 2011
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Publications

Tate SC, Sykes AK, Kulanthaivel P, Chan EM, Turner PK, Cronier DM. A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients. Clin Pharmacokinet. 2018 Mar;57(3):335-344. doi: 10.1007/s40262-017-0559-8.
PubMed 28540640
Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.
PubMed 24919854

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
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All Advanced Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of a CDK 4/6 Dual Inhibitor in Participants With Advanced Cancer
ClinicalTrials.gov ID: NCT01394016
Acronym / sponsor ID: 13199
Conditions: Advanced Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 7 Dec 2009 (actual)
Primary completion: 29 May 2014 (actual)
Study completion: 12 Apr 2022 (actual)
First posted: 14 Jul 2011 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Abemaciclib	Experimental	Drug: Abemaciclib, Drug: FulvestrantParticipants received oral Abemaciclib administered on Days 1 through 28 of a 28-day cycle except in Cycle 1, where the study drug was administered as appropriate on Day -3 and then on Days 1 to 27. The treatment was continued until a discontinuation criterion was met or under Sponsor's discretion. Participants belonging to different Parts received the study drug as specified below: Part A: 50 mg/100 mg/150 mg/225 mg every 24 hours (Q24H) or 75mg/100 mg/150 mg/200 mg/275 mg every 12 hours (Q12H). Parts B, C, D, and E: 150 mg/200 mg Q12H. Part F: 150 mg Q12H. Part G: 200 mg Q12H along with 500 mg Fulvestrant administered intramuscularly.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

For all Parts (Dose escalation and expansion): The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy either after available standard therapies have ceased to provide clinical benefit (Parts A, B, C, D, E and F) or in combination with fulvestrant (Part G only)
For Dose Escalation (Part A): The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic
For Dose Expansion (Parts B, C, D, E, F and G): The participant must have histological or cytological evidence of one of the following cancers:
As defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma
Have given written informed consent prior to any study-specific procedures

Key exclusion criteria (10 listed)

Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), sudden cardiac death or sudden cardiac arrest
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)
For Dose Escalation (Part A): Have central nervous system (CNS) malignancy or metastasis
For Dose Confirmation (Parts B, D, E, F and G): Have CNS metastasis that is radiographically or clinically unstable less than 14 days prior to receiving study drug, regardless of whether they are receiving corticosteroids

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
AbemaciclibAlso: LY2835219Administered orally.	Drug	Abemaciclib
FulvestrantFulvestrant is administered intramuscularly into the buttocks in Part G only.	Drug	Abemaciclib

Primary outcome

Number of Participants With Clinically Significant Effects
Time frame: Baseline up to 233 weeks
The number of participants with clinically significant findings in the study were reported in this outcome measure.

4 secondary outcomes

Percentage of Participants With Tumor Response - Overall Response Rate (ORR), Disease Control Rate (DCR)
Time frame: Baseline through Study Completion (Up to 285 weeks)
Pharmacokinetics (PK): Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib
Time frame: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
PK: Area Under the Steady State Plasma Concentration-time Curve Over 24 Hours (AUC 0-24hr,ss) of Abemaciclib
Time frame: Day 28 (0, 1, 2, 4, 6, 8, 10, 24 hours post-dose) of Cycle 1
Part A: Recommended Dose for Phase 2 Studies
Time frame: Baseline through Study Completion (Up to 285 weeks)

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A - Cohort 1: 50 Milligrams (mg) Abemaciclib - Every 24 Hours (Q24H)	4	2
Part A - Cohort 2: 100 mg Abemaciclib - Q24H	3	3
Part A - Cohort 3: 150 mg Abemaciclib - Q24H	3	3
Part A - Cohort 4: 225 mg Abemaciclib - Q24H	3	3
Part A - Cohort 5: 75 mg Abemaciclib - Every 12 Hours (Q12H)	3	3
Part A - Cohort 6: 100 mg Abemaciclib - Q12H	4	4
Part A - Cohort 7: 150 mg Abemaciclib - Q12H	3	3
Part A - Cohort 8: 200 mg Abemaciclib - Q12H	7	6
Part A - Cohort 9: 275 mg Abemaciclib - Q12H	3	2
Part B - 150 mg Abemaciclib - Q12H	26	24
Part B - 200 mg Abemaciclib - Q12H	42	38
Part C - 150 mg Abemaciclib - Q12H	2	2
Part C - 200 mg Abemaciclib - Q12H	15	14
Part D - 150 mg Abemaciclib - Q12H	25	22
Part D - 200 mg Abemaciclib - Q12H	22	21
Part E - 150 mg Abemaciclib - Q12H	13	10
Part E - 200 mg Abemaciclib - Q12H	13	11
Part F - 150 mg Abemaciclib - Q12H	15	13
Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant	19	16

Primary outcome: Number of Participants With Clinically Significant Effects

Time frame: Baseline up to 233 weeks. Count of participants. Unit: Participants

Measure	Part A - Cohort 1: 50 mg Abemaciclib - Q24H n = 4	Part A - Cohort 2: 100 mg Abemaciclib - Q24H n = 3	Part A - Cohort 3: 150 mg Abemaciclib - Q24H n = 3	Part A - Cohort 4: 225 mg Abemaciclib - Q24H n = 3	Part A - Cohort 5: 75 mg Abemaciclib - Q12H n = 3	Part A - Cohort 6: 100 mg Abemaciclib - Q12H n = 4	Part A - Cohort 7: 150 mg Abemaciclib - Q12H n = 3	Part A - Cohort 8: 200 mg Abemaciclib - Q12H n = 7	Part A - Cohort 9: 275 mg Abemaciclib - Q12H n = 3	Part B - 150 mg Abemaciclib - Q12H n = 26	Part B - 200 mg Abemaciclib - Q12H n = 42	Part C - 150 mg Abemaciclib - Q12H n = 2	Part C - 200 mg Abemaciclib - Q12H n = 15	Part D - 150 mg Abemaciclib - Q12H n = 25	Part D - 200 mg Abemaciclib - Q12H n = 22	Part E - 150 mg Abemaciclib - Q12H n = 13	Part E - 200 mg Abemaciclib - Q12H n = 13	Part F - 150 mg Abemaciclib - Q12H n = 15	Part G - 200 mg Abemaciclib (Q12H) + Fulvestrant n = 19
Value	0	0	0	0	0	0	0	1	2	1	5	0	1	2	4	0	2	0	6

Population analysed: All participants who received at least one dose of the study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through End of Treatment (Up to 645 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - Cohort 1: 50 mg Abemaciclib - Q24H	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Part A - Cohort 2: 100 mg Abemaciclib - Q24H	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A - Cohort 3: 150 mg Abemaciclib - Q24H	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A - Cohort 4: 225 mg Abemaciclib - Q24H	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part A - Cohort 5: 75 mg Abemaciclib - Q12H	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A - Cohort 6: 100 mg Abemaciclib - Q12H	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Part A - Cohort 7: 150 mg Abemaciclib - Q12H	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Part A - Cohort 8: 200 mg Abemaciclib - Q12H	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7
Part A - Cohort 9: 275 mg Abemaciclib - Q12H	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3
Part B - 150 mg Abemaciclib - Q12H	7 of 26 (26.9%)	26 of 26 (100%)	3 of 26
Part B - 200 mg Abemaciclib - Q12H	15 of 42 (35.7%)	42 of 42 (100%)	15 of 42
Part C - 150 mg Abemaciclib - Q12H	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Part C - 200 mg Abemaciclib - Q12H	3 of 15 (20%)	15 of 15 (100%)	7 of 15
Part D - 150 mg Abemaciclib - Q12H	5 of 25 (20%)	25 of 25 (100%)	4 of 25
Part D - 200 mg Abemaciclib - Q12H	7 of 22 (31.8%)	22 of 22 (100%)	0 of 22
Part E - 150 mg Abemaciclib - Q12H	5 of 13 (38.5%)	13 of 13 (100%)	1 of 13
Part E - 200 mg Abemaciclib - Q12H	5 of 13 (38.5%)	13 of 13 (100%)	5 of 13
Part F - 150 mg Abemaciclib - Q12H

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28540640Tate SC, Sykes AK, Kulanthaivel P, Chan EM, Turner PK, Cronier DM. A Population Pharmacokinetic and Pharmacodynamic Analysis of Abemaciclib in a Phase I Clinical Trial in Cancer Patients. Clin Pharmacokinet. 2018 Mar;57(3):335-344. doi: 10.1007/s40262-017-0559-8.
Derived from this study: PubMed 24919854Gelbert LM, Cai S, Lin X, Sanchez-Martinez C, Del Prado M, Lallena MJ, Torres R, Ajamie RT, Wishart GN, Flack RS, Neubauer BL, Young J, Chan EM, Iversen P, Cronier D, Kreklau E, de Dios A. Preclinical characterization of the CDK4/6 inhibitor LY2835219: in-vivo cell cycle-dependent/independent anti-tumor activities alone/in combination with gemcitabine. Invest New Drugs. 2014 Oct;32(5):825-37. doi: 10.1007/s10637-014-0120-7. Epub 2014 Jun 13.

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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

3 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 Abemaciclib and Fulvestrant in people with Advanced Cancer, run by Eli Lilly and Company at 3 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 21 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). 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?

Number of Participants With Clinically Significant Effects (time frame: Baseline up to 233 weeks). 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 NCT01394016, which also lists 2 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.