Prostate Cancer MetastaticPhase 2PRIMCABNCT02379390
Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide
A Phase 2 study testing Cabazitaxel XRP6258, Ezalutamide and Abiraterone acetate in people with Prostate Cancer Metastatic, run by Sanofi at 24 sites in 2 countries.
Trial summary
Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B)… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- Cabazitaxel XRP6258, Ezalutamide and Abiraterone acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 17 Jun 2015to 10 May 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic disease.
- Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide within 12 months of treatment initiation (≤12 months) by at least one of the following:
- Progression in measurable disease Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Appearance of 2 or more new bone lesions according to Prostate Cancer Working Group 2 (PCWG2).
- Rising PSA defined (PCWG2) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart.
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- A PSA value of at least 2 nanogram/milliliter (ng/mL) is required at study entry.
- Effective castration (serum testosterone levels ≤0.5 ng/mL).
- Prior AR targeted therapy (abiraterone acetate or enzalutamide) must be stopped at least 2 weeks before study treatment.
- Signed written informed consent.
Who cannot join
- Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. No further anti-cancer therapy after the previous AR targeted therapy and before inclusion. Prior docetaxel in hormone sensitive setting is allowed if completed >1 year before randomization. Prior immunotherapy is allowed.
- Less than 28 days elapsed from prior treatment with immunotherapy, radiotherapy, or surgery to the time of randomization.
- Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) at the time of randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status >1.
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
- Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which treatment has been completed ≥5 years ago and from which the patient has been disease-free for ≥5 years.
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- Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
- Acquired immunodeficiency syndrome (AIDS)-related illnesses or known Human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
- Any severe acute or chronic medical condition including uncontrolled diabetes mellitus, severe renal impairment, history of cardiovascular disease (uncontrolled hypertension, arterial thrombotic events in the past 6 months, congestive heart failure, severe or unstable angina pectoris, recent myocardial infraction within last 6 months or uncontrolled cardiac arrhythmia), which could impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
- Participants with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and up to 6 months after the last administered dose. The definition of "effective method of contraception" will be based on the Investigator's judgment.
- Known allergies, hypersensitivity or intolerance to prednisone or excipients of abiraterone acetate or enzalutamide. History of hypersensitivity to docetaxel or polysorbate 80.
- Known history of mineralocorticoid excess or deficiency (not applicable to participants who have already been treated with abiraterone acetate in first line before inclusion).
- History of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold (not applicable to participants who have already been treated with enzalutamide in first line before inclusion).
- Unable to swallow a whole tablet or capsule.
- Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin <10.0 g/dL.
- Absolute neutrophil count <1.5 x 10^9/L.
- Platelet count <100 x 10^9/L.
- Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) >1.5 x Upper limit of normal (ULN).
- Total bilirubin >1.0 x ULN.
- Potassium <3.5 mmol/L.
- Serum albumin <3.0 g/dL.
- Child-Pugh Class B and C.
- Contraindications to the use of corticosteroid treatment.
- Symptomatic peripheral neuropathy grade ≥2 NCI CTCAE v4.0.
- Concomitant vaccination with yellow fever vaccine.
- The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States14 sites
Investigational Site Number 840028
Anaheim, California, 92801
Investigational Site Number 840024
Anchorage, Alaska, 99508
Investigational Site Number 840002
Boca Raton, Florida, 33486
Investigational Site Number 840022
Canton, Ohio, 44718
Investigational Site Number 840001
Covington, Louisiana, 70433
Investigational Site Number 840027
Lakeland, Florida, 33805
Investigational Site Number 840017
Metairie, Louisiana, 70006
Investigational Site Number 840030
Muscle Shoals, Alabama, 35661
Investigational Site Number 840016
Myrtle Beach, South Carolina, 29572
Investigational Site Number 840026
Omaha, Nebraska, 68198
Investigational Site Number 840015
Ottawa, Illinois, 61350
Investigational Site Number 840006
Port Saint Lucie, Florida, 34952
Investigational Site Number 840012
Rockville, Maryland, 20850
Investigational Site Number 840004
Sacramento, California, 95817
Canada10 sites
Investigational Site Number 124003
Edmonton, T6G 1Z2
Investigational Site Number 124010
Greenfield Park, J4V2H1
Investigational Site Number 124005
Hamilton, L8V 5C2
Investigational Site Number 124004
London, N6A 4L6
Investigational Site Number 124002
Montreal, H2L 4M1
Investigational Site Number 124006
Montreal, H2W1S6
Investigational Site Number 124007
Ottawa, K1H8L6
Investigational Site Number 124009
Québec, G1R 2J6
Investigational Site Number 124008
Saskatoon, S7N4H4
Investigational Site Number 124001
Vancouver, N5Z4E6
About this study
Official title: Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABazitaxel to Alternative Androgen Receptors (AR) Targeted Therapy
Primary Objective:
To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months).
Read more
Secondary Objective:
- To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).
- Progression Free Survival (PFS).
- Overall Survival (OS).
- Tumor response rate in participants with measurable disease (RECIST 1.1)
- Pain response and time to pain progression.
- Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.
- To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).
- To evaluate safety in the 2 treatment arms.
Read the detailed description
The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participants refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cutoff date, or withdrawal of participant consent.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Cabazitaxel XRP6258, Ezalutamide, Abiraterone acetate, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabazitaxel XRP6258Drug
Also called Jevtana
EzalutamideDrug
Also called Xtandi
Abiraterone acetateDrug
Also called Zytiga
PrednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | Participants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment. Receives: Drug: Cabazitaxel XRP6258; Drug: Prednisone |
| Abiraterone acetate or Enzalutamide | Active comparator | Participants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment. Receives: Drug: Ezalutamide; Drug: Abiraterone acetate; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-Free Survival (rPFS)
rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
Measured: Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)
Secondary outcomes (10)
Number of Participants With Prostate Specific Antigen (PSA) Response
PSA response was defined as decline of serum PSA from baseline by >= 50 percent (%).
Measured: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Progression-free Survival (PFS)
PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.
Measured: Baseline upto progression or death due to any cause (maximum duration: 1059 days)
Overall Survival
Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.
Measured: Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)
Time to PSA Progression
Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.
Measured: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Number of Participants Achieving Tumor Response
Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.
Measured: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Duration of Tumor Response
Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.
Measured: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score
Pain response was analyzed using the brief pain inventory-short form (BPI-SF).
Measured: Baseline until the end of study (maximum duration: 1059 days)
Time to Pain Progression
Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.
Measured: Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)
Percentage of Participants With Symptomatic Skeletal Event (SSE)
SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.
Measured: Baseline until the end of study (maximum duration: 1059 days)
Time to Occurrence of Any Symptomatic Skeletal Events (SSE)
Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.
Measured: Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start17 Jun 2015
- Primary completion10 May 2018
- Study completion10 May 2018
Why it stopped: Unsatisfactory patient accrual
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 Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379390
- Sponsor's protocol ID
- LPS14022
- Other IDs
- U1111-1160-6008
- Acronym
- PRIMCAB
- Status last verified
- Jun 2019
- First submitted
- 27 Feb 2015
- Last updated
- 21 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABazitaxel to Alternative Androgen Receptors (AR) Targeted Therapy
- ClinicalTrials.gov ID
- NCT02379390
- Acronym / sponsor ID
- PRIMCAB / LPS14022
- Conditions
- Prostate Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsatisfactory patient accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2015 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 21 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months).
Secondary Objective:
- To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).
- Progression Free Survival (PFS).
- Overall Survival (OS).
- Tumor response rate in participants with measurable disease (RECIST 1.1)
- Pain response and time to pain progression.
- Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE.
- To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).
- To evaluate safety in the 2 treatment arms.
Detailed description
The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participants refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cutoff date, or withdrawal of participant consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: Cabazitaxel XRP6258, Drug: PrednisoneParticipants received Cabazitaxel 25 mg/m^2, intravenously for 1 hour along with prednisone 10 mg orally on Day 1 of every treatment cycle (each cycle was of 3 weeks) until disease progression, unacceptable toxicity, or participant's refusal of further study treatment. |
| Abiraterone acetate or Enzalutamide | Active comparator | Drug: Ezalutamide, Drug: Abiraterone acetate, Drug: PrednisoneParticipants received abiraterone acetate 1000 mg (4 tablets of 250 mg), orally once daily along with prednisone 5 mg, orally twice daily from Day 1 to 21 in each treatment cycle (each cycle was of 3 weeks) or enzalutamide 160 mg, orally, until disease progression, unacceptable toxicity, or participant's refusal of further study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of histologically or cytologically confirmed prostate adenocarcinoma.
- Metastatic disease.
- Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide within 12 months of treatment initiation (≤12 months) by at least one of the following:
- Progression in measurable disease Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Appearance of 2 or more new bone lesions according to Prostate Cancer Working Group 2 (PCWG2).
Key exclusion criteria (27 listed)
- Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago. No further anti-cancer therapy after the previous AR targeted therapy and before inclusion. Prior docetaxel in hormone sensitive setting is allowed if completed >1 year before randomization. Prior immunotherapy is allowed.
- Less than 28 days elapsed from prior treatment with immunotherapy, radiotherapy, or surgery to the time of randomization.
- Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.0) at the time of randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status >1.
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal 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 |
|---|---|---|
| Cabazitaxel XRP6258Also: Jevtana | Drug | Cabazitaxel |
| EzalutamideAlso: Xtandi | Drug | Abiraterone acetate or Enzalutamide |
| Abiraterone acetateAlso: Zytiga | Drug | Abiraterone acetate or Enzalutamide |
| Prednisone | Drug | Abiraterone acetate or Enzalutamide, Cabazitaxel |
Primary outcome
Radiographic Progression-Free Survival (rPFS)
Time frame: Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)
rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
10 secondary outcomes
Number of Participants With Prostate Specific Antigen (PSA) Response
Time frame: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Progression-free Survival (PFS)
Time frame: Baseline upto progression or death due to any cause (maximum duration: 1059 days)
Overall Survival
Time frame: Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)
Time to PSA Progression
Time frame: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Number of Participants Achieving Tumor Response
Time frame: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Duration of Tumor Response
Time frame: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score
Time frame: Baseline until the end of study (maximum duration: 1059 days)
Time to Pain Progression
Time frame: Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)
Percentage of Participants With Symptomatic Skeletal Event (SSE)
Time frame: Baseline until the end of study (maximum duration: 1059 days)
Time to Occurrence of Any Symptomatic Skeletal Events (SSE)
Time frame: Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- 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.
Clinical Sciences & Operations study director
Sanofi
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel XRP6258, Ezalutamide and Abiraterone acetate in people with Prostate Cancer Metastatic, run by Sanofi at 24 sites in 2 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 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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 21 Jun 2019). 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?
Radiographic Progression-Free Survival (rPFS) (time frame: Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)). 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 21 Jun 2019.