Ovarian CancerPhase 2NCT00090610
Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer
A Phase 2 study testing Docetaxel and Carboplatin in people with Ovarian Cancer, run by Duke University at 19 sites in United States.
Trial summary
The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Docetaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2003to Oct 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal carcinoma.
- The patient's tumor is platinum-sensitive, which means that the patient had a complete response to front-line treatment with a platinum compound and had a treatment-free interval without clinical evidence of progressive disease for greater than 6 months.
- The patient has received one and only one prior chemotherapy regimen for the treatment of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is allowed. Patients who have received consolidation treatment are allowed. Prior treatment with Taxotere® is not allowed.
- o Consolidation therapy is allowed including a different cytotoxic agent than the agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and immunotherapy.
- Patients may have received one prior regimen with a biologic therapy, either combined with cytotoxic therapy in the front-line setting, or as a single-agent for this recurrence. The biologic therapy must be discontinued at least three weeks prior to registration.
- Measurable or evaluable disease either by radiologic imaging, or physical exam, or by measurement of CA125 < 70 on two occasions at least one week apart.
Show all 15Show fewer
- At least 3 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal.
- At least 3 weeks since major surgery, with full recovery. Patients who have undergone a secondary tumor debulking or cytoreductive surgery for this malignancy are excluded.
- Eastern Cooperative Oncology Group (ECOG) performance status < 2.
- Age > 18 years.
- Absolute neutrophil count > 1,500/mm3; platelet count > 100,000/mm3; Hemoglobin > 8.0 g/dl
- Serum bilirubin Within Normal Limits (WNL); AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
- If there is childbearing potential, a serum pregnancy test must be negative.
- Patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months following the completion of treatment.
- Informed consent has been obtained.
Who cannot join
- Prior treatment with Taxotere®.
- Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the disease. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of Hormone Replacement therapy is permitted.
- Serious concurrent medical or psychiatric illness, including serious active infection.
- Peripheral neuropathy > grade 2.
- History of other malignancy within the last 5 years, except for basal cell skin carcinoma.
- The patient is pregnant or nursing.
- Patients with a history of severe hypersensitivity reaction to cisplatin, carboplatin, mannitol, or drugs formulated with Polysorbate 80.
- Secondary debulking for this recurrence.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Hope: A Woman's Cancer Center
Asheville, North Carolina, 28816
Southwest Regional Cancer Center
Austin, Texas, 78705
Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology
Baltimore, Maryland, 21237-3998
Hematology-Onc. Assoc. of The Quad Cities
Bettendorf, Iowa, 52722
University of North Carolina/ Division of Gyn Oncology
Chapel Hill, North Carolina, 27599-7570
MUSC-Div of Gyn/Oncology
Charleston, South Carolina, 29425
Carolinas Medical Center/Gyn Oncology Department
Charlotte, North Carolina, 28232
Duke University/Division of Gynecologic Oncology
Durham, North Carolina, 27710-0001
Florida Gynecologic Oncology
Fort Myers, Florida, 33901
Cancer Center at Hackensack
Hackensack, New Jersey, 07601
University of Iowa
Iowa City, Iowa, 52242
Jupiter Medical Center-Gynecology Oncology and Gynecology
Jupiter, Florida, 33458
The West Cancer Clinic
Memphis, Tennessee, 38120
Columbia University College of Physicians and Surg
New York, New York, 10032
Gynecologic Oncology and Surgery
Oklahoma City, Oklahoma, 73112
Florida Hospital/Gyn/Onc Department
Orlando, Florida, 32804
PA Hematology/Oncology Associates
Philadelphia, Pennsylvania, 19106
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Multicenter, Randomized, Phase II Comparative Study to Compare Efficacy & Safety of Taxotere®/Carboplatin Combination Therapy vs Sequential Therapy w/ Taxotere® Then Carboplatin as Second-line Treatment of Patients w/ Relapsed, Platinum-sensitive Ovarian Cancer
The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.
Read the detailed description
Primary Objective
The primary objective of the study is to compare the progression-free survival of two treatment regimens:
Taxotere® 30 mg/m2 IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression. (A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.)
Versus
Taxotere® 30 mg/m2 IV on Days 1 and 8, repeated every 21 days up to 6 cycles or until disease progression. Followed by carboplatin (AUC 6) IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere®. A patient who has achieved a complete response on Taxotere® will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin. Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression. (A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.)
Secondary Objectives
The secondary objectives of the study are to compare the objective response rates (defined as a complete response plus partial response), duration of tumor response, median survival, QOL and safety in patients treated with the two regimens described above.
- Conditions
- Ovarian Cancer
- Being tested
- Docetaxel, Carboplatin
- Keywords
- Relapsed ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin
For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin
CarboplatinDrug
Also called Paraplatin
Arm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel.
Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Combination Therapy | Experimental | Docetaxel 30mg/m2 mg IV on Days 1 and 8, in combination with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression Receives: Drug: Docetaxel; Drug: Carboplatin |
| Arm 2 - Sequential Therapy | Experimental | Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression. Once subjects have completed 6 cycles of docetaxel, they receive carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression. Receives: Drug: Docetaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression
Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease.
Measured: Every 6 months, to 18 months
Secondary outcomes (4)
Objective Response Rate
Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.
OR = CR + PR
Measured: Every 6 months, starting at 12 months to 24 months
Quality of Life
Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)
With these instruments, a higher score indicates better health-related quality of life.
Measured: Baseline performed 14 days before first dose, then every other cycle and at study termination
Recurrence-Free Survival
Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.
Measured: Every 6 months starting at 12 months, to 24 months
Median Overall Survival
Measured: Every 6 months starting at 12 months, to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2004 (estimated)
- Study startOct 2003
- Primary completionMar 2009
- Study completionOct 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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Angeles A Secord, MD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090610
- Sponsor's protocol ID
- Pro00008381
- Other IDs
- DUKE UNIVERSITY MEDICAL CENTER, DUMC03
- Status last verified
- Dec 2012
- First submitted
- 27 Aug 2004
- Last updated
- 25 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Alvarez Secord A, Berchuck A, Higgins RV, Nycum LR, Kohler MF, Puls LE, Holloway RW, Lewandowski GS, Valea FA, Havrilesky LJ. A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer. Cancer. 2012 Jul 1;118(13):3283-93. doi: 10.1002/cncr.26610. Epub 2011 Nov 9.
PubMed 22072307Pokrzywinski R, Secord AA, Havrilesky LJ, Puls LE, Holloway RW, Lewandowski GS, Higgins RV, Nycum LR, Kohler MF, Revicki DA. Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: results from a randomized clinical trial. Gynecol Oncol. 2011 Dec;123(3):505-10. doi: 10.1016/j.ygyno.2011.08.015. Epub 2011 Sep 25.
PubMed 21945310Havrilesky LJ, Pokrzywinski R, Revicki D, Higgins RV, Nycum LR, Kohler MF, Berchuck A, Myers ER, Secord AA. Cost-effectiveness of combination versus sequential docetaxel and carboplatin for the treatment of platinum-sensitive, recurrent ovarian cancer. Cancer. 2012 Jan 15;118(2):386-91. doi: 10.1002/cncr.26199. Epub 2011 May 19.
PubMed 21598242
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Phase II Comparative Study to Compare Efficacy & Safety of Taxotere®/Carboplatin Combination Therapy vs Sequential Therapy w/ Taxotere® Then Carboplatin as Second-line Treatment of Patients w/ Relapsed, Platinum-sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00090610
- Acronym / sponsor ID
- Pro00008381
- Conditions
- Ovarian Cancer
- Keywords
- Relapsed ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Oct 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 31 Aug 2004 (estimated)
- Results
- Posted 4 Feb 2013
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 compare the progression-free survival of two treatment regimens for relapsed ovarian cancer.
Detailed description
Primary Objective
The primary objective of the study is to compare the progression-free survival of two treatment regimens:
Taxotere® 30 mg/m2 IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression. (A patient who has completed 6 cycles of treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.)
Versus
Taxotere® 30 mg/m2 IV on Days 1 and 8, repeated every 21 days up to 6 cycles or until disease progression. Followed by carboplatin (AUC 6) IV every 21 days if the patient does not achieve a complete response or has disease progression on Taxotere®. A patient who has achieved a complete response on Taxotere® will be followed until the subsequent recurrence at which time she will then receive single-agent carboplatin. Carboplatin treatment will be discontinued if the patient has completed 6 cycles of treatment and has achieved a complete response or has disease progression. (A patient who has completed 6 cycles of carboplatin treatment and who has achieved a partial response or stable disease may either continue or stop treatment at the investigator's discretion.)
Secondary Objectives
The secondary objectives of the study are to compare the objective response rates (defined as a complete response plus partial response), duration of tumor response, median survival, QOL and safety in patients treated with the two regimens described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Combination Therapy | Experimental | Drug: Docetaxel, Drug: CarboplatinDocetaxel 30mg/m2 mg IV on Days 1 and 8, in combination with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression |
| Arm 2 - Sequential Therapy | Experimental | Drug: Docetaxel, Drug: CarboplatinDocetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression. Once subjects have completed 6 cycles of docetaxel, they receive carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically confirmed epithelial ovarian cancer, peritoneal serous cancer, or tubal carcinoma.
- The patient's tumor is platinum-sensitive, which means that the patient had a complete response to front-line treatment with a platinum compound and had a treatment-free interval without clinical evidence of progressive disease for greater than 6 months.
- The patient has received one and only one prior chemotherapy regimen for the treatment of this malignancy. Prior treatment with paclitaxel and/or a platinum compound is allowed. Patients who have received consolidation treatment are allowed. Prior treatment with Taxotere® is not allowed.
- o Consolidation therapy is allowed including a different cytotoxic agent than the agent used in the front-line regimen, intraperitoneal therapy, biologic therapy, and immunotherapy.
- Patients may have received one prior regimen with a biologic therapy, either combined with cytotoxic therapy in the front-line setting, or as a single-agent for this recurrence. The biologic therapy must be discontinued at least three weeks prior to registration.
Key exclusion criteria (8 listed)
- Prior treatment with Taxotere®.
- Concurrent immunotherapy or hormonal therapy for the specific purpose of treatment for the disease. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to enrollment in order for the patient to be eligible to participate in this trial. Continuation of Hormone Replacement therapy is permitted.
- Serious concurrent medical or psychiatric illness, including serious active infection.
- Peripheral neuropathy > grade 2.
- History of other malignancy within the last 5 years, except for basal cell skin carcinoma.
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 |
|---|---|---|
| DocetaxelAlso: TaxotereFor Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin | Drug | Arm 1 - Combination Therapy, Arm 2 - Sequential Therapy |
| CarboplatinAlso: ParaplatinArm 1: AUC 6 IV on Days 1 and 8, repeated every 21 days for 6 cycles or until disease progression, combined with docetaxel. Arm 2: AUC 6 IV every 21 days for 6 cycles or until disease progression, following six cycles of treatment with docetaxel | Drug | Arm 1 - Combination Therapy, Arm 2 - Sequential Therapy |
Primary outcome
Progression-free Survival (PFS)
Time frame: Every 6 months, to 18 months
Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease.
4 secondary outcomes
Objective Response Rate
Time frame: Every 6 months, starting at 12 months to 24 months
Quality of Life
Time frame: Baseline performed 14 days before first dose, then every other cycle and at study termination
Recurrence-Free Survival
Time frame: Every 6 months starting at 12 months, to 24 months
Median Overall Survival
Time frame: Every 6 months starting at 12 months, to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22072307Alvarez Secord A, Berchuck A, Higgins RV, Nycum LR, Kohler MF, Puls LE, Holloway RW, Lewandowski GS, Valea FA, Havrilesky LJ. A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer. Cancer. 2012 Jul 1;118(13):3283-93. doi: 10.1002/cncr.26610. Epub 2011 Nov 9.
- Results publication: PubMed 21945310Pokrzywinski R, Secord AA, Havrilesky LJ, Puls LE, Holloway RW, Lewandowski GS, Higgins RV, Nycum LR, Kohler MF, Revicki DA. Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: results from a randomized clinical trial. Gynecol Oncol. 2011 Dec;123(3):505-10. doi: 10.1016/j.ygyno.2011.08.015. Epub 2011 Sep 25.
- Results publication: PubMed 21598242Havrilesky LJ, Pokrzywinski R, Revicki D, Higgins RV, Nycum LR, Kohler MF, Berchuck A, Myers ER, Secord AA. Cost-effectiveness of combination versus sequential docetaxel and carboplatin for the treatment of platinum-sensitive, recurrent ovarian cancer. Cancer. 2012 Jan 15;118(2):386-91. doi: 10.1002/cncr.26199. Epub 2011 May 19.
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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.
Angeles A Secord, MD study chair
Duke University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Carboplatin in people with Ovarian Cancer, run by Duke University at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 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 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 Feb 2013). 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?
Progression-free Survival (PFS) (time frame: Every 6 months, to 18 months). 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 NCT00090610, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.