Clinical Trials /

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

NCT03732820

Description:

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
  • Official Title: A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)

Clinical Trial IDs

  • ORG STUDY ID: D081SC00001
  • SECONDARY ID: 2018-002011-10
  • NCT ID: NCT03732820

Conditions

  • Metastatic Castration-resistant Prostate Cancer

Interventions

DrugSynonymsArms
olaparibLynparzaolaparib plus abiraterone
abiraterone acetateZytigaolaparib plus abiraterone

Purpose

The purpose of this study is to evaluate the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agents (NHAs) at metastatic castration-resistant prostate cancer (mCRPC) stage.

Detailed Description

      PROpel is a phase III study evaluating the efficacy, safety, and tolerability of olaparib
      versus placebo when given in addition to abiraterone to patients with metastatic
      castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy or new
      hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC)
      (first-line setting).

      Approximately 720 patients globally will be randomized in PROpel in a 1:1 ratio to treatment
      with either olaparib and abiraterone or placebo and abiraterone. Patients will receive oral
      treatment with olaparib 300 mg twice daily + abiraterone 1000 mg once daily or placebo twice
      daily + abiraterone 1000 mg once daily. Patients in both treatment groups will also receive
      either prednisone or prednisolone 5 mg twice daily.
    

Trial Arms

NameTypeDescriptionInterventions
olaparib plus abirateroneExperimentalOlaparib is available as a film-coated tablet containing 100 milligrams (mg) or 150 milligrams (mg) of olaparib. Subjects will be administered olaparib orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.
  • olaparib
  • abiraterone acetate
placebo plus abirateronePlacebo ComparatorPlacebo to match olaparib is available as a film-coated tablet in 100 milligrams (mg) or 150 milligrams (mg). Subjects will be administered placebo orally at a dose of 300 milligrams (mg) twice daily (bid). The initial dosage of 300 milligrams (mg) twice daily will be composed of 2 x 150 milligrams (mg) tablets per dose. The 100 milligrams (mg) and 150 milligrams (mg) tablets will be used to manage dose reductions during the study. Abiraterone acetate with prednisone or prednisolone will be sourced locally as commercially available materials. Subjects will be administered abiraterone orally at a dose of 1000 milligrams (mg) once daily, in combination with prednisone or prednisolone 5 milligrams (mg) administered orally twice daily.
  • abiraterone acetate

Eligibility Criteria

        Inclusion Criteria:

          1. Capable of giving signed informed consent, which includes compliance with the
             requirements and restrictions listed in the informed consent form and in the study
             protocol.

          2. Provision of signed and dated, written informed consent form prior to any mandatory
             study specific procedures, sampling, and analyses.

          3. For inclusion in i) the optional exploratory genetic research and ii) the optional
             biomarker research, patients must fulfill the following criteria:

               -  Provision of informed consent for genetic research prior to collection of sample.

               -  Provision of informed consent for biomarker research prior to collection of
                  sample.

             If a patient declines to participate in the optional exploratory genetic research or
             the optional biomarker research, there will be no penalty or loss of benefit to the
             patient. The patient will not be excluded from other aspects of the study.

          4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of
             signing the informed consent form. For patients enrolled in Japan who are <20 years of
             age, written informed consent should be obtained from the patient and from his legally
             acceptable representative.

          5. Histologically or cytologically confirmed prostate adenocarcinoma.

          6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone
             scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan.

          7. First-line metastatic castration-resistant prostate cancer (mCRPC).

          8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral
             orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0
             nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving
             androgen deprivation therapy (ADT) at study entry should continue to do so throughout
             the study.

          9. Candidate for abiraterone therapy with documented evidence of progressive disease.

         10. Patients must have normal organ and bone marrow function measured within 28 days prior
             to administration of study treatment.

         11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no
             deterioration over the previous 2 weeks.

         12. The participant has, in the opinion of the investigator, a life expectancy of at least
             6 months.

         13. Prior to randomisation, sites must confirm availability of either an archival formalin
             fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the
             screening window, which meets the minimum pathology and sample requirements in order
             to enable homologous recombination repair (HRR) status subgroup analysis of the
             primary endpoint radiographic progression-free survival (rPFS). If there is not
             written confirmation of the availability of tumour tissue prior to randomisation, the
             patient is not eligible for the study.

         14. Male patients must use a condom during treatment and for 3 months after the last dose
             of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a
             woman of childbearing potential. Female partners of male patients should also use a
             highly effective form of contraception if they are of childbearing potential.

        Exclusion Criteria:

          1. Has a known additional malignancy that has had progression or has required active
             treatment in the last 5 years.

          2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with
             features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).

          3. Clinically significant cardiovascular disease Association Class II-IV heart failure or
             cardiac ejection fraction measurement of <50% during screening as assessed by
             echocardiography or multigated acquisition scan.

          4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.

          5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery
             stenosis).

          6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury
             (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).

          7. History of uncontrolled pituitary or adrenal dysfunction.

          8. Active infection or other medical condition that would make prednisone/prednisolone
             use contraindicated.

          9. Any chronic medical condition requiring a systemic dose of corticosteroid >10
             milligrams (mg) prednisone/prednisolone per day.

         10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical
             disorder, non-malignant systemic disease or active, uncontrolled infection.

         11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade
             >2) caused by previous cancer therapy, excluding alopecia.

         12. Patients with brain metastases. A scan to confirm the absence of brain metastases is
             not required.

         13. Patients with spinal cord compression are excluded unless they are considered to have
             received definitive treatment for this and have evidence of clinically stable disease
             for 4 weeks.

         14. Patients who are unevaluable for both bone and soft tissue progression

         15. Patients who are unable to swallow orally administered medication and patients with
             gastrointestinal disorders likely to interfere with absorption of the study
             medication.

         16. Immunocompromised patients

         17. Patients with known active hepatitis infection (ie, hepatitis B or C).

         18. Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)]
             polymerase (PARP) inhibitor, including olaparib.

         19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative
             reasons) within 3 weeks prior to study treatment. Patients who receive palliative
             radiotherapy need to stop radiotherapy 1 week before randomisation.

         20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase)
             inhibitor (eg, abiraterone, orteronel).

         21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole,
             telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or
             cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate
             CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil).
             The required washout period prior to starting study treatment is 2 weeks.

         22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital,
             enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine
             or St John's wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan,
             efavirenz or modafinil). The required period prior to starting study treatment is 5
             weeks for phenobarbital and enzalutamide and 3 weeks for other agents.

         23. Major surgery within 2 weeks of starting study treatment and patients must have
             recovered from any effects of any major surgery.

         24. Previous allogenic bone marrow transplant or double umbilical cord blood
             transplantation (dUCBT).

         25. Participation in another clinical study with an investigational product or
             investigational medical devices within 1 month of randomisation.

         26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of
             olaparib or abiraterone, or drugs with a similar chemical structure or class to
             olaparib or abiraterone.

         27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
             and Merck staff and/or staff at the study site).

         28. Judgment by the investigator that the patient should not participate in the study if
             the patient is unlikely to comply with study procedures, restrictions and
             requirements.

         29. Previous randomisation in the present study.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Radiological progression free survival (rPFS)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Radiological progression free survival (rPFS) - defined as the time from randomisation to radiographic progression, assessed by investigator per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group-3 (PCWG-3) criteria (bone), or death from any cause, whichever occurs first

Secondary Outcome Measures

Measure:Time to first subsequent anticancer therapy or death (TFST)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Time from randomisation to the earlier of the first subsequent anticancer therapy start date following study treatment discontinuation or death from any cause
Measure:Time to pain progression (TTPP)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Time to pain progression (TTPP) is defined as the time from randomisation to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and opiate analgesic use (analgesic quantification algorithm [AQA] score)
Measure:Overall survival (OS)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Time from randomisation to death from any cause
Measure:Time to opiate use
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Time from randomisation to the first opiate use for cancer-related pain
Measure:Time to a Symptomatic Skeletal-Related Event (SSRE)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:A Symptomatic Skeletal-Related Event (SSRE) is defined as use of radiation therapy to bone in order to prevent or relieve skeletal complications, occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral, resulting from minimal or no trauma), occurrence of radiologically confirmed spinal cord compression or a tumour-related orthopaedic surgical intervention.
Measure:Circulating Tumour Cells (CTC) conversion
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Proportion of patients who achieve a decline in the number of Circulating Tumour Cells (CTCs) from ≥5 cells/7.5 mL at baseline to <5 cells/7.5 mL at any time post baseline in whole blood (Circulating Tumour Cells (CTC) conversion rate)
Measure:Time to second progression or death (PFS2)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Time from randomisation to second progression or clinical progression or death
Measure:Brief Pain Inventory-Short Form (BPI-SF)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:To assess progression in pain severity domain, change in pain interference domain, and pain palliation
Measure:Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
Time Frame:From date of randomization to study completion (up to 4 years)
Safety Issue:
Description:Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) total score, Functional Assessment of Cancer Therapy- General (FACT-G) total score, trial outcome index, functional well-being, physical well-being, prostate cancer subscale, and Functional Assessment of Cancer Therapy (FACT) Advanced Prostate Symptom Index-6 (FAPSI-6)
Measure:Homologous Recombination Repair (HRR) gene status
Time Frame:At baseline
Safety Issue:
Description:Tumour and blood samples for mutations in Breast Cancer 1 gene (BRCA1), or Breast Cancer 2 gene (BRCA2), Ataxia-telangiectasia mutated (ATM) and 12 other Homologous Recombination Repair (HRR) genes will be evaluated.
Measure:Maximum plasma concentration at steady state [Cmax,ss]
Time Frame:Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of olaparib, in the presence of abiraterone.
Measure:Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
Time Frame:Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of olaparib, in the presence of abiraterone.
Measure:Minimum plasma concentration at steady state [Cmin,ss]
Time Frame:Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of olaparib, in the presence of abiraterone.
Measure:Partial area under the concentration-time curve in 0-8 h [AUC0-8])
Time Frame:Week 5 from 45 min before the first olaparib dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of olaparib, in the presence of abiraterone.
Measure:Maximum plasma concentration at steady state [Cmax,ss]
Time Frame:Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of abiraterone and its active metabolite Δ4-abiraterone, in the presence and absence of olaparib.
Measure:Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss]
Time Frame:Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of abiraterone and its active metabolite Δ4-abiraterone, in the presence and absence of olaparib.
Measure:Minimum plasma concentration at steady state [Cmin,ss]
Time Frame:Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of abiraterone and its active metabolite Δ4-abiraterone, in the presence and absence of olaparib.
Measure:Partial area under the concentration-time curve [AUC0-8])
Time Frame:Week 5 from 45 min before the abiraterone dose, up to 9 hours post dose
Safety Issue:
Description:To characterize the steady state Pharmacokinetics (PK) of abiraterone and its active metabolite Δ4-abiraterone, in the presence and absence of olaparib.
Measure:Number of adverse events
Time Frame:From the time of signature of informed consent throughout the treatment period (up to 4 years plus 30 days)
Safety Issue:
Description:Percentage of patients with any adverse event (AE), adverse event (AE) leading to study drug discontinuation, adverse event (AE) leading to death, serious adverse event (SAE), adverse event (AE) related to study drug, serious adverse event (SAE) related to study drug
Measure:Vital signs-blood pressure
Time Frame:From the time of signature of informed consent throughout the treatment period (up to 4 years plus 30 days)
Safety Issue:
Description:To assess systolic and diastolic blood pressure as variable of safety and tolerability of the combination of olaparib and arbiraterone vs placebo and arbiraterone
Measure:Vital signs-pulse rate
Time Frame:From the time of signature of informed consent throughout the treatment period (up to 4 years)
Safety Issue:
Description:To assess pulse rate as variable of safety and tolerability of the combination of olaparib and arbiraterone vs placebo and arbiraterone
Measure:Vital signs-body temperature
Time Frame:From the time of signature of informed consent throughout the treatment period (up to 4 years)
Safety Issue:
Description:To assess body temperature as variable of safety and tolerability of the combination of olaparib and arbiraterone vs placebo and arbiraterone
Measure:ECG
Time Frame:From the time of signature of informed consent throughout the treatment period (up to 4 years)
Safety Issue:
Description:To assess 12 lead resting ECG as variable of safety and tolerability of the combination of olaparib and arbiraterone vs placebo and arbiraterone. According to Clinical Study Protocol all ECGs should be assessed by the investigator as to whether they are clinically significantly abnormal / not clinically significantly abnormal.
Measure:Change in Albumin (g/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Albumin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Alkaline phosphatase (U/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Alkaline phosphatase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Aspartate aminotransferase (U/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Aspartate aminotrasnferase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Amylase (U/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Amylase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Alanine aminotransferase (U/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Alanine aminotransferase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Total bilirubin (μmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Total bilirubin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Direct bilirubin
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Direct bilirubin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Calcium (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Calcium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Chloride (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Chloride recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Creatinine (μmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Creatinine recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Gamma glutamyltransferase (U/L)
Time Frame:At screening only
Safety Issue:
Description:Data for Gamma glutamyltransferase recorded in the eCRF will be listed and summarized by treatment group.
Measure:Change in Fasting gucose (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Fasting glucose recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Lactate dehydrogenase (U/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Lactate dehydrogenase recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Magnesium (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Magnesium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Potassium (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Potassium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Phosphorus ((mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Phosphorus will be recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Sodium (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Sodium recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Carbon dioxide (mEq/L )
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Carbon dioxide recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Total protein (g/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for protein recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for urea or urea nitrogen recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in absolute neutrophil count (/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for absolute neutrophil recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in absolute lymphocyte count (/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for absolute lymphocyte recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in haemoglobin (g/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for haemoglobin recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in platelet count with differential (/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for platelet count with differential recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in total white blood cell count with differential(/L)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for WBC count recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in red blood cell count (/l)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for RBC count recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Haematocrit (%)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for Haematocrit recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Change in Mean Cell Volume (fL)
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for MCV count recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Urinalysis:change in blood
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for blood testing recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Urinalysis: Change in protein
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for urine protein recorded in the eCRF will be listed and summarized by treatment group and visit.
Measure:Urinalysis: change in glucose
Time Frame:At scheduled visits from screening to 30 days after last dose of study medication
Safety Issue:
Description:Data for urine glucose recorded in the eCRF will be listed and summarized by treatment group and visit.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • metastatic castration-resistant prostate cancer (mCRPC)

Last Updated

December 6, 2019