Solid TumorsPhase 1NCT01047007

A Dose Escalation Study of Adavosertib(MK1775) in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005

A Phase 1 study testing adavosertib 20 mg, 5-FU 1000 mg/m^2/day and CDDP in people with Solid Tumors, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Solid Tumors
What is being tested?: adavosertib 20 mg, 5-FU 1000 mg/m^2/day and CDDP
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: No sites listed yet
Study dates: 18 Jan 2010to 15 Jun 2011
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
Parts 2-B and 3: Patient must have a histologically or cytologically confirmed locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a candidate of 5-Fluorouracil and Cisplatin regimen defined in this study
Patient must have performance status of 0 or 1 on the ECOG Performance Scale

Who cannot join

Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
Patient with a known primary central nervous system tumor
Patient has known hypersensitivity to any of the components of the combination study therapy or its analogs
Patient is receiving "alternative" cancer medications such as plant-derived products and their analogs with anti-tumor activity within 1 week prior to entering the study.
Patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy

About this study

Official title: A Phase I Dose Escalation Study of MK1775 in Monotherapy, in Combination With 5-Fluorouracil, and in Combination With 5-Fluorouracil and Cisplatin in Patients With Advanced Solid Tumor

The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.

Conditions: Solid Tumors
Being tested: adavosertib 20 mg, 5-FU 1000 mg/m^2/day, CDDP, adavosertib 65 mg
Keywords: Head and Neck Cancer, Esophageal Cancer, Gastric Cancer
Medical subject headings: Head and Neck Neoplasms, Esophageal Neoplasms, Stomach Neoplasms

What participants receive

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

adavosertib 20 mgDrug
Also called MK-1775
Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle.
5-FU 1000 mg/m^2/dayDrug
5-FU 1000 mg/m^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle
CDDPDrug
Also called Cisplatin
CDDP 60 mg/m^2 to 100 mg/m^2 administered as an IV infusion on Day 1.
adavosertib 65 mgDrug
Also called MK-1775
Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle.

Study groups in NCT01047007
Study group	Role	What they receive
Part 1: adavosertib 65 mg BID	Experimental	Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. Receives: Drug: adavosertib 65 mg
Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg	Experimental	Participants received 20 mg of adavosertib administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle. Receives: Drug: adavosertib 20 mg; Drug: 5-FU 1000 mg/m^2/day
Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg	Experimental	Participants received 20 mg of adavosertib administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle. Receives: Drug: adavosertib 20 mg; Drug: 5-FU 1000 mg/m^2/day
Parts 2B +3: adavosertib+5-FU+CDDP	Experimental	Participants were to receive 20 mg or 65 mg of adavosertib administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1. Receives: Drug: adavosertib 20 mg; Drug: 5-FU 1000 mg/m^2/day; Drug: CDDP; Drug: adavosertib 65 mg

What is being measured

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

Number of Participants With Dose Limiting Toxicities (DLTs)
DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2.
Measured: Cycle 1 (21 days)
Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer
The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic esophageal, head and neck, or gastric cancer was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.
Measured: Cycle 1 (21 days)

Secondary outcomes (1)

MTD of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Solid Tumors
The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic solid tumors was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.
Measured: Cycle 1 (21 days)

Timeline

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

18 Jan 201015 Jun 2011

First posted12 Jan 2010 (estimated)
Study start18 Jan 2010
Primary completion15 Jun 2011
Study completion15 Jun 2011

Why it stopped: The study has been terminated due to business reasons.

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 Solid TumorsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01047007
Sponsor's protocol ID: 1775-005
Other IDs: MK1775-005
Status last verified: Aug 2023
First submitted: 11 Jan 2010
Last updated: 21 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Dose Escalation Study of MK1775 in Monotherapy, in Combination With 5-Fluorouracil, and in Combination With 5-Fluorouracil and Cisplatin in Patients With Advanced Solid Tumor
ClinicalTrials.gov ID: NCT01047007
Acronym / sponsor ID: 1775-005
Conditions: Solid Tumors
Keywords: Head and Neck Cancer, Esophageal Cancer, Gastric Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study has been terminated due to business reasons.
Enrolment: 11 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 18 Jan 2010 (actual)
Primary completion: 15 Jun 2011 (actual)
Study completion: 15 Jun 2011 (actual)
First posted: 12 Jan 2010 (estimated)
Results: Posted 17 Jul 2018

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Part 1: adavosertib 65 mg BID	Experimental	Drug: adavosertib 65 mgParticipants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.
Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg	Experimental	Drug: adavosertib 20 mg, Drug: 5-FU 1000 mg/m^2/dayParticipants received 20 mg of adavosertib administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.
Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg	Experimental	Drug: adavosertib 20 mg, Drug: 5-FU 1000 mg/m^2/dayParticipants received 20 mg of adavosertib administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle.
Parts 2B +3: adavosertib+5-FU+CDDP	Experimental	Drug: adavosertib 20 mg, Drug: 5-FU 1000 mg/m^2/day, Drug: CDDP, Drug: adavosertib 65 mgParticipants were to receive 20 mg or 65 mg of adavosertib administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m^2 to 100 mg/m^2 of CDDP administered as an IV infusion on Day 1.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
Parts 2-B and 3: Patient must have a histologically or cytologically confirmed locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a candidate of 5-Fluorouracil and Cisplatin regimen defined in this study
Patient must have performance status of 0 or 1 on the ECOG Performance Scale

Key exclusion criteria (5 listed)

Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
Patient with a known primary central nervous system tumor
Patient has known hypersensitivity to any of the components of the combination study therapy or its analogs
Patient is receiving "alternative" cancer medications such as plant-derived products and their analogs with anti-tumor activity within 1 week prior to entering the study.
Patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy

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
adavosertib 20 mgAlso: MK-1775Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle.	Drug	Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg, Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg, Parts 2B +3: adavosertib+5-FU+CDDP
5-FU 1000 mg/m^2/day5-FU 1000 mg/m^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle	Drug	Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg, Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg, Parts 2B +3: adavosertib+5-FU+CDDP
CDDPAlso: CisplatinCDDP 60 mg/m^2 to 100 mg/m^2 administered as an IV infusion on Day 1.	Drug	Parts 2B +3: adavosertib+5-FU+CDDP
adavosertib 65 mgAlso: MK-1775Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle.	Drug	Part 1: adavosertib 65 mg BID, Parts 2B +3: adavosertib+5-FU+CDDP

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (21 days)
DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity preventing treatment for ≥3 weeks or preventing administration of ≥8 of 10 doses in Parts 1 or 2A1 or 4 of 5 doses in Part 2A2.
Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer
Time frame: Cycle 1 (21 days)
The maximum tolerated dose (MTD) of MK-1775 in combination with 5-FU/CDDP for participants with locally advanced or metastatic esophageal, head and neck, or gastric cancer was determined based on DLTs that occurred during Cycle 1 of Parts 2B and 3. The MTD for MK-1775 in combination with 5-FU/CDDP was defined as the dose level at which approximately 30% of the participants were expected to experience a DLT for the combination therapy. The study was terminated early and Parts 2B and 3 were not performed. No participants received the 5-FU/CDDP regimen therefore the MTD for MK-1775 in combination with 5-FU/CDDP was not established.

1 secondary outcome

MTD of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Solid Tumors
Time frame: Cycle 1 (21 days)

Results and safety

Results posted to the registry on 17 Jul 2018, 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 1: MK-1775 65 mg BID	3	1
Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg	6	0
Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg	2	0
Parts 2B +3: MK-1775 + 5-FU + CDDP	0	0

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs)

Time frame: Cycle 1 (21 days). Number. Unit: Participants

Measure	Part 1: MK-1775 65 mg BID n = 3	Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg n = 6	Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg n = 2	Parts 2B +3: MK-1775 + 5-FU + CDDP n = 0
Value	0	1	1	–

Population analysed: The DLT-evaluable population consisted of participants who received at least one dose of MK-1775 and completed Cycle 1 of Parts 1, 2A1, 2A2, or discontinued due to toxicity.

Primary outcome: Maximum Tolerated Dose (MTD) of MK1775 in Combination With 5-FU/CDDP Determined by Number of DLTs Per Dose Level: Locally Advanced or Metastatic Esophageal, Head and Neck, or Gastric Cancer

Time frame: Cycle 1 (21 days)

Population analysed: Participants who received at least one dose of MK-1775 in combination with 5-FU/CDDP and completed Cycle 1 of Parts 2B and 3. No participants received the 5-FU/CDDP regimen due to early termination of the study.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of MK-1775 alone or in combination with 5-FU through follow-up; up to 7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: MK-1775 65 mg BID	0 of 3 (0%)	3 of 3 (100%)	Not reported
Part 2 A1: MK-1775 20 mg BID + 5-FU 1000 mg	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
Part 2 A2: MK-1775 20 mg QD + 5-FU 1000 mg	1 of 2 (50%)	1 of 2 (50%)	Not reported

Limitations and caveats (from the sponsor): Study terminated due to business reasons. Study Parts 2B and 3 were not done.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing adavosertib 20 mg, 5-FU 1000 mg/m^2/day and CDDP in people with Solid Tumors, run by Merck Sharp & Dohme LLC.

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 3 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: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

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 17 Jul 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?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (21 days)). 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?

On the ClinicalTrials.gov record for NCT01047007.

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 21 Sep 2023.