Colorectal CancerPhase 2NCT00967616
Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy
A Phase 2 study testing CS7017 and irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) in people with Colorectal Cancer and Neoplasms, Colorectal, run by Daiichi Sankyo at 18 sites in 5 countries.
Trial summary
This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoplasms, Colorectal
- What is being tested?
- CS7017 and irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Sep 2009to Apr 2013
- 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
- Metastatic CRC that has progressed following first-line therapy.
- Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST], Version 1.0.
- Male or female ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade ≤ 1.
- Adequate organ and bone marrow function as evidenced by:
Show all 16Show fewer
- Hemoglobin ≥ 9 g/dL (transfusion and/or growth factor support allowed)
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min
- Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN in participants with no liver metastasis and ≤ 5.0 x ULN in participants with liver metastasis
- Total bilirubin ≤ 1.5 x ULN
- Women of childbearing potential must be willing to consent to using effective contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter. Men who are the partner of a woman of childbearing potential must be willing to consent to using effective contraception (eg, vasectomy or barrier with spermicide) while on treatment and for 3 months thereafter.
- All female participants of childbearing potential must have a negative pregnancy test (serum or urine) result before initiating study treatment.
- Participants must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Independent Ethics Committee (IEC)- or Institutional Review Board (IRB)-approved informed consent form (ICF) (including HIPAA authorization, if applicable) before performance of any study-specific procedures or tests.
- Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- First-line treatment with an irinotecan-based regimen (eg, FOLFIRI).
- Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
- Treatment with chemotherapy, other thiazolidinediones (TZD), RT, surgery, immunotherapy, biological therapy, or any investigational anticancer agent within 4 weeks before start of study treatment.
- History of any of the following conditions within 6 months before initiating study treatment:
- Diabetes mellitus requiring treatment with insulin or TZD agents
- Myocardial infarction with significant impairment of cardiac function (eg, ejection fraction ≤ 50%)
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- Severe/unstable angina pectoris
- Coronary/peripheral artery bypass graft
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
- Participants with clinically active brain metastases (defined as untreated, symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms); uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Participants with treated brain metastasis will be included in the study if they have recovered from the acute, toxic effects of RT. A minimum of 15 days must have elapsed between the end of RT and enrollment into the study.
- History of malignancy other than CRC, unless there is an expectation that the malignancy has been cured, and tumor-specific treatment for the malignancy has not been administered within the previous 5 years.
- Clinically significant, severe, active infection requiring IV antibiotic or antiviral agents.
- Pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Participants with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
- Need for concomitant use of other TZD agents during the study.
- Previous administration of CS-7017.
- Pregnant or breast feeding.
- Known to be homozygous for the UGT1A1*28 allele.
- Known history of severe hypersensitivity reactions to any of the components of CS-7017, irinotecan, leucovorin, or 5-FU.
- Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment.
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
United States6 sites
Georgia Cancer Specialists
Atlanta, Georgia, 30341
Victor Priego
Bethesda, Maryland, 20817
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Gabrail Cancer Center
Canton, Ohio, 44718
St. Jude Heritage Medical Group
Fullerton, California, 92835
John Marshall
Washington D.C., District of Columbia, 20007
Peru4 sites
Hospital Nacional Alberto Sabogai Sologuren
Callao
Hospital Nacional Dos de Mayo
Lima, 01
Oncosalud SAC
Lima, 41
Hospital Nacional Dos de Mayo
Lima
Brazil3 sites
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul - PUC-RS
Porto Alegre, 90610-000
Instituto Nacional de Cancer INCA
Rio de Janeiro, 20231-050
ICAVC
São Paulo, 01209-000
Chile3 sites
Fundacion Arturo Lopez Perez
Santiago, 8320000
Instituto Nacional del Cancer
Santiago, 8380455
Instituto Oncologico Clinica Renaca
Viña del Mar, 2540364
Argentina2 sites
Instituto FIDES Oncologia y Especialidades Medicas
Buenos Aires, B1900BAJ
CAIPO Centro para la Atencion Integral del Paciente Oncologico
San Miguel de Tucumán, T4000GTB
About this study
Official title: Randomized, Active-Controlled, Open-Label Phase 2 Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy
This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.
- Conditions
- Colorectal Cancer, Neoplasms, Colorectal
- Being tested
- CS7017, irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)
- Keywords
- metastatic, colon, rectum, combination, chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS7017Drug
CS-7017 (0.25mg tablet) Two CS-7017 tablets will be administered by mouth (PO) BID every 12 hours. FOLFIRI will be administered IV once every 2 weeks.
irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)Drug
Also called Irinotecan, Leucovorin, 5-FU, 5-fluorouracil
FOLFIRI will be administered IV once every 2 weeks.
The FOLFIRI regimen consists of:
- Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes
- Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion
- 5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion)
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI | Active comparator | Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of:
* Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion) Receives: Drug: irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) |
| CS7017+FOLFIRI | Experimental | Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered by mouth (PO) twice a day (BID) every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of:
* Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes
* Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion
* 5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion) Receives: Drug: CS7017; Drug: irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression-Free Survival at 16 Weeks After Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
Progression-free survival (PFS) was defined as the time from randomization until the first objective evidence of disease progression or death from any cause.
Measured: Baseline to 16 weeks postdose
Secondary outcomes (4)
Median Overall Progression-Free Survival Following Administration of CS-7017 in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) (FOLFIRI) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
Progression-free survival (PFS) was defined as the time from randomization until the first objective evidence of disease progression or death from any cause.
Measured: Baseline to approximately 3 years postdose
Median Overall Progression-Free Survival: Sensitivity Analysis Including Clinical Progression After Administration of CS-7017 and Irinotecan, Leucovorin, and 5-Fluorouracil After Failure of First-line Therapy of Metastatic Colorectal Cancer
Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first. The sensitivity analysis included clinical progression as an event.
Measured: Baseline to approximately 3 years postdose
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil (FOLFIRI) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
As per Response Evaluation Criteria for Solid Tumors v1.0, best overall response was characterized as confirmed complete response (CR) defined as disappearance of all target lesions, confirmed partial response (PR) defined as ≥30% decrease from baseline, stable disease (SD) defined as neither progressive disease (PD) nor PR, and PD defined as ≥20% increase from smallest sum of longest diameter recorded since treatment started. Objective response rate (ORR) was defined as CR + PR. If there is no tumor assessment after the first dose of study drug, the best overall response is classified as Inevaluable.
Measured: Baseline to approximately 3 years postdose
Treatment-Emergent Adverse Events Occurring in ≥10% of Participants Following Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (FOLFIRI) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
An adverse event (AE) >30 days after last dose of study drug was not included as a treatment-emergent adverse events (TEAE) unless considered related to treatment.
Measured: Baseline to 30 days post last dose, up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2013
- Study completionApr 2013
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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967616
- Sponsor's protocol ID
- CS7017-A-U203
- Status last verified
- Apr 2020
- First submitted
- 27 Aug 2009
- Last updated
- 4 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Active-Controlled, Open-Label Phase 2 Study of CS-7017 in Combination With FOLFIRI in Subjects With Metastatic Colorectal Cancer Who Failed First-Line Therapy
- ClinicalTrials.gov ID
- NCT00967616
- Acronym / sponsor ID
- CS7017-A-U203
- Conditions
- Colorectal Cancer, Neoplasms, Colorectal
- Keywords
- metastatic, colon, rectum, combination, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 4 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2, randomized, active-controlled, open-label, parallel group, multicenter study will be conducted at up to 18 study centers in the US, Central America, and South America. Adult subjects with metastatic colorectal cancer (CRC) who failed first-line chemotherapy will participate in the study, which will be conducted on an outpatient basis. It is anticipated that 100 subjects will be enrolled to obtain approximately 90 evaluable subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI | Active comparator | Drug: irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)Participants who received irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). FOLFIRI was administered by intravenous (IV) injection once every 2 weeks. The FOLFIRI regimen consisted of: * Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes * Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion * 5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion) |
| CS7017+FOLFIRI | Experimental | Drug: CS7017, Drug: irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)Participants who received CS7017 plus irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI). Two CS-7017 tablets were administered by mouth (PO) twice a day (BID) every 12 hours. FOLFIRI was administered IV once every 2 weeks. The FOLFIRI regimen consisted of: * Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes * Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion * 5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Metastatic CRC that has progressed following first-line therapy.
- Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST], Version 1.0.
- Male or female ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade ≤ 1.
Key exclusion criteria (20 listed)
- First-line treatment with an irinotecan-based regimen (eg, FOLFIRI).
- Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study.
- Treatment with chemotherapy, other thiazolidinediones (TZD), RT, surgery, immunotherapy, biological therapy, or any investigational anticancer agent within 4 weeks before start of study treatment.
- History of any of the following conditions within 6 months before initiating study treatment:
- Participants with clinically active brain metastases (defined as untreated, symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms); uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis. Participants with treated brain metastasis will be included in the study if they have recovered from the acute, toxic effects of RT. A minimum of 15 days must have elapsed between the end of RT and enrollment into 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 |
|---|---|---|
| CS7017CS-7017 (0.25mg tablet) Two CS-7017 tablets will be administered by mouth (PO) BID every 12 hours. FOLFIRI will be administered IV once every 2 weeks. | Drug | CS7017+FOLFIRI |
| irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI)Also: Irinotecan, Leucovorin, 5-FU, 5-fluorouracilFOLFIRI will be administered IV once every 2 weeks. The FOLFIRI regimen consists of: * Irinotecan, 180 mg/m^2 IV infusion over 30 to 120 minutes * Leucovorin, 400 mg/m^2 IV infusion to match the duration of the irinotecan infusion * 5-FU, 1200 mg/m^2/day x 2 days (total 2400 mg/m^2 over 46 to 48 hours continuous infusion) | Drug | CS7017+FOLFIRI, FOLFIRI |
Primary outcome
Percentage of Participants With Progression-Free Survival at 16 Weeks After Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
Time frame: Baseline to 16 weeks postdose
Progression-free survival (PFS) was defined as the time from randomization until the first objective evidence of disease progression or death from any cause.
4 secondary outcomes
Median Overall Progression-Free Survival Following Administration of CS-7017 in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) (FOLFIRI) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
Time frame: Baseline to approximately 3 years postdose
Median Overall Progression-Free Survival: Sensitivity Analysis Including Clinical Progression After Administration of CS-7017 and Irinotecan, Leucovorin, and 5-Fluorouracil After Failure of First-line Therapy of Metastatic Colorectal Cancer
Time frame: Baseline to approximately 3 years postdose
Best Overall Response and Objective Response Rate Following Administration of CS-7017 in Combination With Irinotecan, Leucovorin, and 5-Fluorouracil (FOLFIRI) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
Time frame: Baseline to approximately 3 years postdose
Treatment-Emergent Adverse Events Occurring in ≥10% of Participants Following Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (FOLFIRI) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer
Time frame: Baseline to 30 days post last dose, up to approximately 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CS7017 and irinotecan, leucovorin, and 5-fluorouracil (5-FU) (FOLFIRI) in people with Colorectal Cancer and Neoplasms, Colorectal, run by Daiichi Sankyo at 18 sites in 5 countries.
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 16 inclusion and 20 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 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Peru, Brazil, Chile, Argentina. 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 May 2020). 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?
Percentage of Participants With Progression-Free Survival at 16 Weeks After Administration of CS-7017 Combined With Irinotecan, Leucovorin, and 5-Fluorouracil (5-FU) After Failure of First-line Therapy in Treatment of Metastatic Colorectal Cancer (time frame: Baseline to 16 weeks postdose). 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 May 2020.