Non-small Cell Lung Cancer (NSCLC)Phase 1NCT00683904
Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer
A Phase 1 study testing Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL and Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL in people with Non-small Cell Lung Cancer (NSCLC), run by R-Pharm at 1 site in Japan.
Trial summary
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL and Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2008to Sep 2009
- 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
- Age ≥20 years
- Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
- Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent
- No prior chemotherapy-containing regimens for the treatment of NSCLC
- Eastern Cooperative Oncology Group performance status of 0-1
- Life expectancy of at least 12 weeks
- Accessible for treatment and follow up; patients who could be hospitalized for first 15 days of Cycle 1
- Adequate recovery from previous systemic therapy (at least 3 weeks for surgery or radiation therapy)
Who cannot join
- Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug
- Women pregnant or breast feeding
- Women with a positive pregnancy test result on enrollment or prior to study drug administration
- Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP
- Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases
- Prior radiation must not have included ≥30% of major bone-marrow-containing areas (pelvis, lumbar spine)
Show all 22Show fewer
- Common Terminology Criteria (CTC) Grade 2 or greater neuropathy
- Psychiatric or other disorders rendering the patient incapable of complying with protocol requirements
- Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix (Patients with a history of malignancy but without evidence of disease for 5 years are eligible)
- Serious uncontrolled medical disorder or active systemic infection that would impair the ability of the subject to receive protocol therapy.
- Myocardial infarction, unstable angina, or unstable congestive heart failure within 6 months
- Known history of infection with human immunodeficiency virus
- Inadequate bone marrow function
- Inadequate hepatic function
- Inadequate renal function
- Known prior severe hypersensitivity reaction (CTC Grade 2 or greater) to agents containing Cremophor®EL
- Known severe hypersensitivity reaction to agents containing carboplatin and other platinum
- Prior treatment with an epothilone and/or with platinum
- History of high-dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years
- On treatment with strong Cytochrome P450 3A4 inhibitor
- Current imprisonment
- Compulsorily detention for treatment of psychiatric or physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment
The purpose of this study is to determine the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL, Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mLDrug
Also called IXEMPRA, BMS-247550
On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mLDrug
After all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL | Active comparator | Not described Receives: Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL | Active comparator | Not described Receives: Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Toxicity (DLT)
DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.
Measured: Days 1 through 21 (Cycle 1)
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2
The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.
Measured: Days 1 through 21 (Cycle 1)
Secondary outcomes (13)
Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation
An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongs existing hospitalization. An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.
Measured: Days 1 through 21 (Cycle 1)
Number of Participants With Grade 3 or Greater Treatment-related AEs
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs graded according to CTC, Version 3.0. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening. Treatment-related comprises certainly, probably, and possibly related and of unknown relationship to study drug.
Measured: Days 1 through 21 (Cycle 1)
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
LLN=lower level of normal; ULN=upper level of normal. Hemoglobin (g/dL; LLN=11.3; ULN=14.9); leukocytes (*10^3 c/uL; LLN=4.1; ULN=6.1); lymphocytes (*10^3 c/uL); neutrophils (absolute), neutrophils + bands (*10^3 c/uL); platelet count (*10^9 c/L; LLN=131; ULN=365)
Appendix 7.1.2
Measured: At screening and Days 8 and 15 of Cycle 1 (21 days)
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
ULN=upper limit of normal; LLN=lower limit of normal. Alkaline phosphatase=ALP(LLN=115; ULN=359) (U/L); alanine aminotransferase=ALT (LLN=8; ULN=42)(U/L); aspartate aminotransferase=AST (LLN=13; ULN=33) (U/L); albumin (LLN=3.7; ULN=5.2)(g/dL); bilirubin (LLN=0.3; ULN=1.2)(mg/dL); calcium (LLN=8.7; ULN=10.3)(mg/dL); creatinine (LLN=0.6; ULN=1.1)(mg/dL); potassium (LLN=3.6; ULN=4.9) (mEq/L); sodium (LLN=138; ULN=146) (mEq/L)
Measured: At screening and Days 8 and 15 of Cycle 1 (21 days)
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Toxicities graded according to CTC, Version 3. Protein Gr 1: <1.0 g/24 hrs (1+); Gr 2: 1.0 to 3.4 g/24 hrs (2+ to 3+ ); Gr 3: >=3.5 g/24 hrs (4+); Gr 4: Nephrotic syndrome. Note: + = qualitative measure of urine chemistry.
Measured: At screening and Days 8 and 15 of Cycle 1 (21 days)
Number of Participants With Abnormalities in Blood Pressure and Heart Rate
Blood pressure and heart rate obtained before ixabepilone infusion, every 1 hour during and at the end of ixabepilone infusion, and at the end of carboplatin infusion in Cycle 1. For subsequent cycles, vital signs obtained before ixabepilone infusion, at the end of ixabepilone infusion, and at the end of carboplatin infusion. Any new or worsening clinically significant changes since last entry were recorded as appropriate AE or SAE.
Measured: At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
Participants weighed same day as serum chemistry tests. Body surface area recalculated only if body weight changes >10%. ECOG criteria used to assess disease progression and affects on daily living abilities and to determine appropriate treatment and prognosis. Grade 1=Restricted physical activity but ambulatory and capable of light work; Grade 2=Ambulatory, capable of self care, but unable to carry out any work activities; Grade 3=Capable of limited self care, confined to bed or chair 50% or more of waking hours; Grade 4=Completely disabled, totally confined to bed or chair.
Measured: At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
Tumor response was assessed using the RECIST assessment: Complete response (CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial response (PR)=At least 30% reduction in the sum of the longest diameters of all target lesions; Progressive disease (PD)=At least 20% increase in the sum of the longest diameters of all target lesions; Stable disease (SD)=Neither PR nor PD criteria were met.
Measured: Days 1 through 21 (Cycle 1)
Maximum Observed Plasma Concentration of Ixabepilone
Measured: Days 1 to 8 of Cycle 1 (21 days)
Time of Maximum Observed Plasma Concentration of Ixabepilone
Measured: Days 1 to 8 of Cycle 1 (21 days)
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone
Measured: Days 1 to 8 of Cycle 1 (21 days)
Volume of Distribution at Steady State of Ixabepilone
Measured: Days 1 to 8 of Cycle 1 (21 days)
Total Body Clearance of Ixabepilone
Measured: Days 1 to 8 of 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.
- First posted26 May 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionSep 2009
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 Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683904
- Sponsor's protocol ID
- CA163-160
- Status last verified
- Feb 2016
- First submitted
- 22 May 2008
- Last updated
- 10 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Ixabepilone in Combination With Carboplatin in Patients With Non-small Cell Lung Cancer as First-line Treatment
- ClinicalTrials.gov ID
- NCT00683904
- Acronym / sponsor ID
- CA163-160
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 15 Apr 2011
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 the maximum tolerated dose, dose-limiting toxicity, and recommended Phase II dose of ixabepilone in combination with carboplatin in patients with non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL | Active comparator | Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL | Active comparator | Drug: Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥20 years
- Histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC)
- Advanced NSCLC, defined as stage IIIB (without indications for radiotherapy), stage IV, or recurrent
- No prior chemotherapy-containing regimens for the treatment of NSCLC
- Eastern Cooperative Oncology Group performance status of 0-1
Key exclusion criteria (22 listed)
- Women of childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for study period and for up to 4 weeks after last dose of study drug
- Women pregnant or breast feeding
- Women with a positive pregnancy test result on enrollment or prior to study drug administration
- Sexually active fertile men not using effective birth control for the entire study period and for up to 3 months after the last dose of study drug if their partners are WOCBP
- Patients with symptomatic or requiring treatment for brain metastases and/or leptomeningeal metastases
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 |
|---|---|---|
| Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mLAlso: IXEMPRA, BMS-247550On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, intravenous (IV) solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 5 mg/min/mL, intravenous IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. | Drug | Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL |
| Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mLAfter all participants in Dose Level 1 (ixabepilone, 32 mg/m^2 + carboplatin, 5 mg/min/mL) have been observed for 1 full 21-day cycle, Dose Level 2(ixabepilone, 32 mg/m^2 + carboplatin, 6 mg/min/mL) opened. On Day 1 of each 21-day cycle, ixabepilone, 32 mg/m^2, IV solution administered as a 3-hour infusion; 30 minutes after the end of ixabepilone infusion, carboplatin, 6 mg/min/mL, IV solution infused over 30 minutes. Repeated once every 3 weeks, for a maximum of 6 cycles. | Drug | Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL |
Primary outcome
Number of Participants With Dose-limiting Toxicity (DLT)
Time frame: Days 1 through 21 (Cycle 1)
DLT is defined as any of the following: Common Terminology Criteria (CTC), Version 3, Grade(Gr) 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for at least 5 days or febrile neutropenia; Gr 4 thrombocytopenia (<25,000 cells/mm^3 or bleeding needing platelet transfusion); Gr 3 or 4 nausea, vomiting, or diarrhea, despite medical intervention; any other drug-related Gr 3 or 4 nonhematologic toxicity, except Gr 3 injection site reaction, fatigue/asthenia, transient arthralgia/myalgia, or transient electrolytes abnormal. Gr 1=Mild; Gr 2=Moderate; Gr 3=Severe; Gr 4=Life-threatening.
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of Carboplatin in Combination With Ixabepilone, 32 mg/m^2
Time frame: Days 1 through 21 (Cycle 1)
The MTD was defined as the highest dose evaluated for which less than one sixth of patients experience a DLT in Cycle 1. The recommended phase 2 dose is the MTD defined in Cycle 1, with consideration given to chronic cumulative toxicity occurring at later cycles.
13 secondary outcomes
Number of Participants With Death as Outcome, Treatment-related Serious Adverse Events (SAEs), SAEs, Adverse Events (AEs), and Treatment-related AEs Leading to Discontinuation
Time frame: Days 1 through 21 (Cycle 1)
Number of Participants With Grade 3 or Greater Treatment-related AEs
Time frame: Days 1 through 21 (Cycle 1)
Number of Participants With Abnormalities in Hematology Laboratory Values by Worst CTC Grade
Time frame: At screening and Days 8 and 15 of Cycle 1 (21 days)
Number of Participants With Abnormalities in Serum Chemistry Laboratory Values by Worst CTC Grade
Time frame: At screening and Days 8 and 15 of Cycle 1 (21 days)
Number of Participants With Abnormalities in Urine Testing Results by Worst CTC Grade
Time frame: At screening and Days 8 and 15 of Cycle 1 (21 days)
Number of Participants With Abnormalities in Blood Pressure and Heart Rate
Time frame: At screening and Day 1 of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
Number of Participants With Abnormalities in Weight and Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: At screening of Cycle 1 (21 days) and Day 1 of Cycle 2 (Study day 22)
Number of Participants at Each Response Evaluation Criteria in Solid Tumors (RECIST) Assessment
Time frame: Days 1 through 21 (Cycle 1)
Maximum Observed Plasma Concentration of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Time of Maximum Observed Plasma Concentration of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Volume of Distribution at Steady State of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Total Body Clearance of Ixabepilone
Time frame: Days 1 to 8 of Cycle 1 (21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ixabepilone, 32 mg/m^2 + Carboplatin, 5 mg/min/mL and Ixabepilone, 32 mg/m^2 + Carboplatin, 6 mg/min/mL in people with Non-small Cell Lung Cancer (NSCLC), run by R-Pharm at 1 site in Japan.
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 8 inclusion and 22 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 15 Apr 2011). 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 Toxicity (DLT) (time frame: Days 1 through 21 (Cycle 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.