Advanced Solid CancersPhase 1/2NCT00886782

A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

A Phase 1/2 study testing Cdc7-inhibitor in people with Advanced Solid Cancers and Metastatic Cancer, run by Bristol-Myers Squibb at 6 sites in 3 countries.

Terminated

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

Official record

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Trial summary

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Cancers, Metastatic Cancer
What is being tested?: Cdc7-inhibitor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 6 sitesin 3 countries
Study dates: 31 May 2009to 4 Aug 2010
Phase: Phase 1/2
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

None listed.

Who cannot join

Women who are pregnant or breastfeeding
Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
Exposure to any investigational agent within 4 weeks of study drug administration
Subjects a history of gastrointestinal disease

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

United States3 sites

Dana-Farber Cancer Institute-Vendor
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Karmanos Cancer Institute
Detroit, Michigan, 48201

Other trials in United States

Canada2 sites

Local Institution - 003
Toronto, Ontario, M5G 2M9
Local Institution
Toronto, Ontario, M5G 2M9

Other trials in Canada

France1 site

Local Institution
Villejuif, 94800

Other trials in France

About this study

Official title: A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Conditions: Advanced Solid Cancers, Metastatic Cancer
Being tested: Cdc7-inhibitor
Keywords: Advanced and/or Metastatic solid cancers
Medical subject headings: Neoplasm Metastasis

What participants receive

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

Cdc7-inhibitorDrug
Also called BMS-863233, XL413
Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months

Study groups in NCT00886782
Study group	Role	What they receive
Cdc7-inhibitor	Experimental	Not described Receives: Drug: Cdc7-inhibitor

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) of BMS-863233
DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Measured: Up to 28 days
Number of Participants With Adverse Events (AEs)
Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose to 30 days post last dose (Up to 14 months)
Number of Participants Who Died
Number of participants who died due to any cause.
Measured: From first dose to 30 days post last dose (Up to 14 months)
Number of Participants With Lab Abnormalities Grade 3-4
Number of participants with lab abnormalities grade 3-4 including hematology, chemistry, coagulation, liver and kidney function, and electrolytes using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Grade 3 = severe Grade 4 = very severe
Measured: From first dose to 30 days post last dose (Up to 14 months)

Secondary outcomes (13)

BMS-863233 Maximum Observed Plasma Concentration (Cmax)
BMS-863233 maximum observed plasma concentration (Cmax) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax)
BMS-863233 time of maximum observed plasma concentration (Tmax) is derived from plasma concentration versus time data.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
BMS-863233 Area under the concentration-time curve in one dosing interval (AUC(TAU)) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Clearance (CL)
BMS-863233 clearance (CL) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Effective Elimination Half-Life (T-HALFeff)
Effective elimination half-life (T-HALFeff) is derived from plasma concentration versus time data.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 36-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Accumulation Index (AI_AUC)
BMS-863233 accumulation index (AI_AUC) is derived from plasma concentration versus time data. AI is calculated based on ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Trough Observed Plasma Concentration (Ctrough)
BMS-863233 trough observed plasma concentration (Ctrough) is derived from plasma concentration versus time data. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Measured: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 24-hours end-of-infusion on Cycle 1 Day 2 (C1D2), (C1D7, or D8, or D9), and C1D14
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Measured: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C3D1, C4D1, C1D2, C1D15, C3D15,
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Measured: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Measured: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
Measured: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1
Objective Response Rate (ORR)
ORR is defined as the total percentage of participants whose best response is either a complete response (CR) or a partial response (PR) defined by the RECIST criteria.
CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions.
Measured: From first dose up to 14 months
Disease Control Rate (DCR)
DCR is defined as the total percentage of participants whose best response is complete response (CR), partial response (PR), or ≥ 4 months stable disease (SD) defined by the RECIST criteria.
CR= Complete disappearance of all tumor lesions. PR= Decrease, relative to baseline, of 30% or greater in the sum of the longest diameter of all "target" lesions.
SD= Failure to meet criteria for complete or partial response, in the absence of progressive disease.
Measured: From first dose up to 14 months

Timeline

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

31 May 20094 Aug 2010

First posted23 Apr 2009 (estimated)
Study start31 May 2009
Primary completion4 Aug 2010
Study completion4 Aug 2010

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 Advanced Solid CancersStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00886782
Sponsor's protocol ID: CA198-002
Other IDs: EUDRACT Number: 2009-010572-20
Status last verified: Apr 2023
First submitted: 22 Apr 2009
Last updated: 28 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Cancers trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-863233 in Subjects With Advanced and/or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT00886782
Acronym / sponsor ID: CA198-002
Conditions: Advanced Solid Cancers, Metastatic Cancer
Keywords: Advanced and/or Metastatic solid cancers
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 11 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Exelixis
Study start: 31 May 2009 (actual)
Primary completion: 4 Aug 2010 (actual)
Study completion: 4 Aug 2010 (actual)
First posted: 23 Apr 2009 (estimated)
Results: Posted 28 Apr 2023

Clinical summary

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

The purpose of this study is to determine safety, tolerability and maximum tolerated dose of BMS-863233 in subjects advanced and/or Metastatic solid tumors.

Study design

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

Arm	Type	Receives
Cdc7-inhibitor	Experimental	Drug: Cdc7-inhibitor

Who may qualify

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

Key inclusion criteria (0 listed)

Key exclusion criteria (4 listed)

Women who are pregnant or breastfeeding
Subjects with known or suspected brain metastasis, primary brain tumors, or brain as the only site of disease
Exposure to any investigational agent within 4 weeks of study drug administration
Subjects a history of gastrointestinal disease

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
Cdc7-inhibitorAlso: BMS-863233, XL413Capsules, Oral, QD x 14 days until MTD is reached, 14d per 28 day cycle/QD 12 months	Drug	Cdc7-inhibitor

Primary outcome

Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233
Time frame: Up to 28 days
DLT is defined based on adverse events that are deemed to be drug-related and occur during the first cycle of therapy using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
Number of Participants With Adverse Events (AEs)
Time frame: From first dose to 30 days post last dose (Up to 14 months)
Number of participants with any grade adverse events (AEs), any grade drug-related AEs, any grade serious adverse events (SAEs), any grade drug-related SAEs, and any grade AEs leading to discontinuation of any drug. The severity of AEs will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Number of Participants Who Died
Time frame: From first dose to 30 days post last dose (Up to 14 months)
Number of participants who died due to any cause.
Number of Participants With Lab Abnormalities Grade 3-4
Time frame: From first dose to 30 days post last dose (Up to 14 months)
Number of participants with lab abnormalities grade 3-4 including hematology, chemistry, coagulation, liver and kidney function, and electrolytes using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade 3 = severe Grade 4 = very severe

13 secondary outcomes

BMS-863233 Maximum Observed Plasma Concentration (Cmax)
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU))
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Clearance (CL)
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Effective Elimination Half-Life (T-HALFeff)
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 36-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Accumulation Index (AI_AUC)
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-hours end-of-infusion on Cycle 1 Day 1, Cycle 1 Day 14
BMS-863233 Trough Observed Plasma Concentration (Ctrough)
Time frame: PK assessment include the following timepoints: predose, 0.5-, 1-, 2-, 4-, 5-, 6-, 8-, 24-hours end-of-infusion on Cycle 1 Day 2 (C1D2), (C1D7, or D8, or D9), and C1D14
Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Time frame: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C3D1, C4D1, C1D2, C1D15, C3D15,
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval
Time frame: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1
Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Interval
Time frame: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1
Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval
Time frame: Baseline and Predose, 2-, 4-, 8-, and 24-hours post dose on Cycle 1 Day 1 (C1D1), C1D14, C3D1, C3D15, C4D1
Objective Response Rate (ORR)
Time frame: From first dose up to 14 months
Disease Control Rate (DCR)
Time frame: From first dose up to 14 months

Results and safety

Results posted to the registry on 28 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BMS-863233 25 mg	3	0
BMS-863233 50 mg	3	0
BMS-863233 100 mg	5	0

Primary outcome: Number of Participants With Dose Limiting Toxicities (DLTs) of BMS-863233

Time frame: Up to 28 days. Count of participants. Unit: Participants

Measure	BMS-863233 25 mg n = 3	BMS-863233 50 mg n = 3	BMS-863233 100 mg n = 5
Value	0	0	1

Population analysed: All treated participants

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From first dose to 30 days post last dose (Up to 14 months). Count of participants. Unit: Participants

Measure	BMS-863233 25 mg n = 3	BMS-863233 50 mg n = 3	BMS-863233 100 mg n = 5
AEs	3	3	5
Drug-related AEs	1	0	4
SAEs	1	1	4
Drug-related SAEs	0	0	2
AEs leading to discontinuation	0	0	2

Population analysed: All treated participants

Primary outcome: Number of Participants Who Died

Time frame: From first dose to 30 days post last dose (Up to 14 months). Count of participants. Unit: Participants

Measure	BMS-863233 25 mg n = 3	BMS-863233 50 mg n = 3	BMS-863233 100 mg n = 5
Value	0	1	2

Population analysed: All treated participants

Primary outcome: Number of Participants With Lab Abnormalities Grade 3-4

Time frame: From first dose to 30 days post last dose (Up to 14 months). Count of participants. Unit: Participants

Measure	BMS-863233 25 mg n = 3	BMS-863233 100 mg n = 5
Hematology: Hemoglobin, low	0	1
Hematology: Platelet Count, low	0	1
Hematology: Lymphocytes, low	0	1
Coagulation	0	0
Liver and Kidney Function	0	1
Electrolytes: Hyponatremia, low	1	1
Electrolytes: Phosphorus, low	0	1
Other Chemistry Testing	0	0

Population analysed: All treated participants

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 14 months). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 14 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMS-863233 25 mg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
BMS-863233 50 mg	1 of 3 (33.3%)	2 of 3 (66.7%)	1 of 3
BMS-863233 100 mg	4 of 5 (80%)	5 of 5 (100%)	2 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Advanced Solid Cancers

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
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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cdc7-inhibitor in people with Advanced Solid Cancers and Metastatic Cancer, run by Bristol-Myers Squibb at 6 sites in 3 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 0 inclusion and 4 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada, France. 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 combined 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.

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 28 Apr 2023). 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) of BMS-863233 (time frame: Up to 28 days). The study lists 4 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 NCT00886782.

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 28 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.