Prostate CancerPhase 1/2KHLADNCT00953576
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
A Phase 1/2 study testing ketoconazole, hydrocortisone and dutasteride in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ketoconazole, hydrocortisone and dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2009to 11 Apr 2013
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CRPC with metastatic bone disease. At least one site of metastatic disease must be amenable to a needle biopsy. Bone sites include lumbar vertebrae, pelvic bones and long bones. Excluded sites are thoracic, cervical vertebrae, skull and rib lesions
- Patients may have had a number of previous hormonal therapies including ketoconazole and abiraterone, provided these were discontinued >3 months before starting the trial
- Patients may have had any number of previous cytotoxic therapies
- Castrate resistant disease as defined by PSA working group. Patients must have a rise in PSA on two successive determinations at least one week apart and PSA levels 5ng/ml or greater and testosterone levels <50
- Adequate renal, hepatic and bone marrow function as outlined in protocol
- PTT< 60, INR <1.5NL unless on warfarin therapy
Show all 16Show fewer
- > 6 month life expectancy
- At least a 4 week interval from previous treatment other than LHRH analog and bisphosphonates. Patients on bicalutamide must have discontinued this medication for at least 6 weeks to be eligible
- Patients receiving bisphosphonate can be maintained on this therapy
- No major surgery or radiation therapy within 4 weeks
- No strontium-89 or samarium-153 therapy within 4 weeks
- ECG showing normal QT interval
- No thromboembolism in past 6 months
- Age > 18 years
- Investigator must check current patient medications against the list of CYP3A4 inhibitors and inducers prior to registration
- Echocardiogram or MUGA demonstrating ejection fraction within institutional normal limits
Who cannot join
- No previous therapy with lapatinib
- No previous therapy with ketoconazole within 3 months of starting trial
- The use of complementary therapy directed at prostate cancer treatment excluding the following: green tea, commercial multivitamin preparations. Vitamin B complex, C, D, E and multivitamins are permitted if these are being taken at less than 3 times the RDA
- The concomitant use of drugs known to be narrow therapeutic index CYP3A4 substrates are excluded
- Drugs that are sensitive to CYP3A4 substrates are excluded
- Patients taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes are excluded.
Show all 18Show fewer
- Patients who have alcohol or drug dependence currently or in the last 6 months are excluded from this study
- Any other events, other than those defined above, in the opinion of the investigator, may make the patient ineligible for this trial
- No contraindication to biopsy such as bleeding disorders. Patients on anticoagulants such as warfarin must be able to safely stop the drug for a three-day period. Patients may not go on heparin during this time
- No active malignancy other than skin cancer or superficial bladder cancer
- Cardiac disease: congestive heart failure > class II NYHA. Patients must no have unstable angina or new onset angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients must have an ejection fraction within normal limits at the enrolling institution based on an echocardiogram
- Uncontrolled hypertension defined as sustained BP > 160 and diastolic > 100 despite optimal medical management
- Known HIV or chronic Hep B or C
- Thrombolic or embolic events such as CVA within the last 6 months
- Pulmonary hemorrhage or any bleeding event CTCAE Grade 2 or greater within 6 months of first dose of study drug of KHAD
- Serious non-healing wound, ulcer, or bone fracture
- Evidence of history of bleeding diathesis or coagulopathy
- Major surgery or significant traumatic injury within 4 weeks of first study drug of KHAD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase I/II Trial of Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Castration Resistant Prostate Cancer With Pre- and Post-therapy Tumor Biopsies
The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope that signaling from the receptors will be turned off and therefore make the participant's cancer more responsive to KHAD treatment.
Read the detailed description
The current study builds on investigators' KHAD experience by further targeting pathways that may still be enhancing AR activity despite reduced testosterone and DHT. Importantly, studies from several groups have shown that EGFR and Her2/Neu activation can enhance AR signaling and increase AR transcriptional activity in response to low levels of androgens. Evaluation in the clinic and lab has shown that there is increased expression of EGFR or Her2/Neu in CRPC. In addition to upregulation in EGFR and Her2/Neu protein expression, signaling through these receptors may be enhanced in some tumors by increases in growth factor levels or other mechanisms. Based on these results, the investigators suggest that EGFR and Her2/Neu contribute to enhancing AR transcriptional activity especially at low androgen levels. If this hypothesis is correct, then dual blockade of EGFR and Her2/Neu in CRPC should enhance the ability of KHAD to abrogate AR activity. Moreover, as androgens can protect PCa cells from cell death in response to EGFR/Her2/Neu/PI3 kinase pathway inhibition, we propose that KHAD plus lapatinib may be a particularly active combination therapy for CRPC.
- Conditions
- Prostate Cancer
- Being tested
- ketoconazole, hydrocortisone, dutasteride, lapatinib
- Keywords
- castration resistant prostate cancer, KHAD
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoconazoleDrug
Also called Nizoral
hydrocortisoneDrug
Also called Cortef, Hydrocortone
dutasterideDrug
Also called Avodart
lapatinibDrug
Also called lapatinib ditosylate, Tyverb
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose Level 1 (DL1): KHAD+L (250 mg) | Experimental | For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day
Participants are treated until unacceptable toxicity, disease progression or withdrawal. Receives: Drug: ketoconazole; Drug: hydrocortisone; Drug: dutasteride; Drug: lapatinib |
| Phase I Dose Level 2 (DL2): KHAD+L (500 mg) | Experimental | For the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day Receives: Drug: ketoconazole; Drug: hydrocortisone; Drug: dutasteride; Drug: lapatinib |
| All Phase I Participants | Experimental | For the initial four weeks (1 cycle=28 days), participants receive KHAD treatment.
Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day
Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: according to the established dose escalation schedule
Participants are treated until unacceptable toxicity, disease progression or withdrawal. Receives: Drug: ketoconazole; Drug: hydrocortisone; Drug: dutasteride; Drug: lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lapatinib Maximum Tolerated Dose (MTD) [Phase I]
The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.
Measured: The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).
Lapatinib Dose Limiting Toxicity (DLT) [Phase I]
A DLT is defined as an adverse event (AE) occurring during the first cycle of KHLAD treatment that are determined to related to the Lapatinib or the combination as follows:
- Any Grade 3 or greater non-hematological treatment related (possible, probable, or definite attribution) including diarrhea
- Grade 4 or greater for hematological toxicities, regardless of attribution.
- Grade 3 skin reactions, pulmonary reactions, regardless of attribution.
Measured: The evaluation for DLT occurred continuously through one cycle of treatment (28 days).
Plasma Lapatinib Levels [Phase I]
Plasma lapatinib levels were measured after day 28 of KHLAD treatment. Participants were instructed to fast prior to samples being taken.
Measured: After first 28 days of KHLAD treatment
Secondary outcomes (1)
Grade 3-4 Treatment-Related Adverse Events Rate
All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted to calculate the proportion of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.
Measured: Assessed each cycle throughout treatment. Treatment duration in months was a median (range) of 5.4 months (range 1 day-8.3 months). Thus, AEs were evaluated up to 8.3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study start29 Sep 2009
- Primary completion11 Apr 2013
- Study completion11 Apr 2013
Why it stopped: The study terminated early due to concerns about drug toxicity.
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- The Phase I dose escalation schedule was to evaluate up to 4 dose levels of lapatinib as well as one step down dose for ketoconazole (-1). This is not a 'parallel assignment' since this dose escalation design proceeds in sequence not in parallel.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Prostate Cancer Foundation Clinical Research Consortium, GlaxoSmithKline
- Responsible party
- Principal investigator, Glenn Bubley, MD, Dana-Farber Cancer Institute
- Investigators
- Glenn Bubley, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953576
- Sponsor's protocol ID
- 08-374
- Acronym
- KHLAD
- Status last verified
- Jul 2018
- First submitted
- 4 Aug 2009
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Castration Resistant Prostate Cancer With Pre- and Post-therapy Tumor Biopsies
- ClinicalTrials.gov ID
- NCT00953576
- Acronym / sponsor ID
- KHLAD / 08-374
- Conditions
- Prostate Cancer
- Keywords
- castration resistant prostate cancer, KHAD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated early due to concerns about drug toxicity.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Prostate Cancer Foundation Clinical Research Consortium, GlaxoSmithKline
- Study start
- 29 Sep 2009 (actual)
- Primary completion
- 11 Apr 2013 (actual)
- Study completion
- 11 Apr 2013 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 4 Sep 2018
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 research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope that signaling from the receptors will be turned off and therefore make the participant's cancer more responsive to KHAD treatment.
Detailed description
The current study builds on investigators' KHAD experience by further targeting pathways that may still be enhancing AR activity despite reduced testosterone and DHT. Importantly, studies from several groups have shown that EGFR and Her2/Neu activation can enhance AR signaling and increase AR transcriptional activity in response to low levels of androgens. Evaluation in the clinic and lab has shown that there is increased expression of EGFR or Her2/Neu in CRPC. In addition to upregulation in EGFR and Her2/Neu protein expression, signaling through these receptors may be enhanced in some tumors by increases in growth factor levels or other mechanisms. Based on these results, the investigators suggest that EGFR and Her2/Neu contribute to enhancing AR transcriptional activity especially at low androgen levels. If this hypothesis is correct, then dual blockade of EGFR and Her2/Neu in CRPC should enhance the ability of KHAD to abrogate AR activity. Moreover, as androgens can protect PCa cells from cell death in response to EGFR/Her2/Neu/PI3 kinase pathway inhibition, we propose that KHAD plus lapatinib may be a particularly active combination therapy for CRPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The Phase I dose escalation schedule was to evaluate up to 4 dose levels of lapatinib as well as one step down dose for ketoconazole (-1). This is not a 'parallel assignment' since this dose escalation design proceeds in sequence not in parallel.
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose Level 1 (DL1): KHAD+L (250 mg) | Experimental | Drug: ketoconazole, Drug: hydrocortisone, Drug: dutasteride, Drug: lapatinibFor the initial four weeks (1 cycle=28 days), participants receive KHAD treatment. Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 250 mg orally 1x day Participants are treated until unacceptable toxicity, disease progression or withdrawal. |
| Phase I Dose Level 2 (DL2): KHAD+L (500 mg) | Experimental | Drug: ketoconazole, Drug: hydrocortisone, Drug: dutasteride, Drug: lapatinibFor the initial four weeks (1 cycle=28 days), participants will receive KHAD treatment. Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants will start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: 500 mg orally 1x day |
| All Phase I Participants | Experimental | Drug: ketoconazole, Drug: hydrocortisone, Drug: dutasteride, Drug: lapatinibFor the initial four weeks (1 cycle=28 days), participants receive KHAD treatment. Ketoconazole: 400 mg orally 3x day Hydrocortisone: 30 mg (a.m.) and 10 mg (p.m.) orally 2x day Dutasteride: 0.5 mg orally 1x day Participants start KHLAD on day 29 or d1 of cycle 2/ week 5. Lapatinib: according to the established dose escalation schedule Participants are treated until unacceptable toxicity, disease progression or withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with CRPC with metastatic bone disease. At least one site of metastatic disease must be amenable to a needle biopsy. Bone sites include lumbar vertebrae, pelvic bones and long bones. Excluded sites are thoracic, cervical vertebrae, skull and rib lesions
- Patients may have had a number of previous hormonal therapies including ketoconazole and abiraterone, provided these were discontinued >3 months before starting the trial
- Patients may have had any number of previous cytotoxic therapies
- Castrate resistant disease as defined by PSA working group. Patients must have a rise in PSA on two successive determinations at least one week apart and PSA levels 5ng/ml or greater and testosterone levels <50
- Adequate renal, hepatic and bone marrow function as outlined in protocol
Key exclusion criteria (18 listed)
- No previous therapy with lapatinib
- No previous therapy with ketoconazole within 3 months of starting trial
- The use of complementary therapy directed at prostate cancer treatment excluding the following: green tea, commercial multivitamin preparations. Vitamin B complex, C, D, E and multivitamins are permitted if these are being taken at less than 3 times the RDA
- The concomitant use of drugs known to be narrow therapeutic index CYP3A4 substrates are excluded
- Drugs that are sensitive to CYP3A4 substrates are excluded
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 |
|---|---|---|
| ketoconazoleAlso: Nizoral | Drug | All Phase I Participants, Phase I Dose Level 1 (DL1): KHAD+L (250 mg), Phase I Dose Level 2 (DL2): KHAD+L (500 mg) |
| hydrocortisoneAlso: Cortef, Hydrocortone | Drug | All Phase I Participants, Phase I Dose Level 1 (DL1): KHAD+L (250 mg), Phase I Dose Level 2 (DL2): KHAD+L (500 mg) |
| dutasterideAlso: Avodart | Drug | All Phase I Participants, Phase I Dose Level 1 (DL1): KHAD+L (250 mg), Phase I Dose Level 2 (DL2): KHAD+L (500 mg) |
| lapatinibAlso: lapatinib ditosylate, Tyverb | Drug | All Phase I Participants, Phase I Dose Level 1 (DL1): KHAD+L (250 mg), Phase I Dose Level 2 (DL2): KHAD+L (500 mg) |
Primary outcome
Lapatinib Maximum Tolerated Dose (MTD) [Phase I]
Time frame: The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).
The MTD of lapatinib in combination with KHAD is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various dose levels of lapatinib under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the lapatinib dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached and the Recommended Phase II Dose (RP2D) will be based on safety and pharmacokinetic results.
Lapatinib Dose Limiting Toxicity (DLT) [Phase I]
Time frame: The evaluation for DLT occurred continuously through one cycle of treatment (28 days).
A DLT is defined as an adverse event (AE) occurring during the first cycle of KHLAD treatment that are determined to related to the Lapatinib or the combination as follows: 1. Any Grade 3 or greater non-hematological treatment related (possible, probable, or definite attribution) including diarrhea 2. Grade 4 or greater for hematological toxicities, regardless of attribution. 3. Grade 3 skin reactions, pulmonary reactions, regardless of attribution.
Plasma Lapatinib Levels [Phase I]
Time frame: After first 28 days of KHLAD treatment
Plasma lapatinib levels were measured after day 28 of KHLAD treatment. Participants were instructed to fast prior to samples being taken.
1 secondary outcome
Grade 3-4 Treatment-Related Adverse Events Rate
Time frame: Assessed each cycle throughout treatment. Treatment duration in months was a median (range) of 5.4 months (range 1 day-8.3 months). Thus, AEs were evaluated up to 8.3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Glenn Bubley, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ketoconazole, hydrocortisone and dutasteride in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 2 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 16 inclusion and 18 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 4 Sep 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?
Lapatinib Maximum Tolerated Dose (MTD) [Phase I] (time frame: The evaluation for MTD occurred continuously through one cycle of KHLAD treatment (28 days).). The study lists 3 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 4 Sep 2018.