Prostate Cancer MetastaticPhase 2NCT04028388
ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer
A Phase 2 study testing Docetaxel in Parenteral Dosage Form and ModraDoc006/r in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Modra Pharmaceuticals at 28 sites in 6 countries.
Trial summary
This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic, Castration-resistant Prostate Cancer
- What is being tested?
- Docetaxel in Parenteral Dosage Form and ModraDoc006/r
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 17 Jul 2019to 29 Nov 2021
- 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
- Age ≥ 18 years
- Histologically or cytologically proven prostate cancer with evidence of progressive mCRPC, defined as:
- Castrate levels of testosterone, defined as ≤ 50 ng/dL (or ≤ 0.50 ng/mL or 1.73 nmol/L)
- Evidence of progressive metastatic disease as defined by radiographic disease progression or Prostate Specific Antigen (PSA) progression
- With an indication for systemic treatment with docetaxel according to the standard of care
- Measurable tumour lesions, defined as pelvic and/or extra-pelvic nodal lesions ≥1.5 cm in the short axis or visceral lesions ≥1.0 cm in the longest dimensions and measurable according to RECIST v1.1, bone metastasis as evaluated with 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy
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- Resolution of toxicity of prior therapy to < grade 2 (except for alopecia), as defined by CTCAE v5.0
- Adequate haematological, renal and hepatic functions:
- Hemoglobin ≥ 6.0 mmol/l (>9.6 g/dL)
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109 /L
- Platelet count ≥ 100 x 109 /L
- Hepatic function defined by serum bilirubin ≤ Upper Limit of Normal (ULN), Alanine Amino Transferase (ALAT) and Aspartate Amino Transferase (ASAT) ≤ 1.5 x ULN concomitant with alkaline phosphatase ≤ 2.5 × ULN.
- Renal function defined by serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula, or MDRD).
- World Health Organisation Performance Status (WHO-PS) of 0-2
- Estimated life expectancy of at least 12 weeks
- Able and willing to swallow oral medication
- Able and willing to undergo radiologic scans (CT scan)
- Able and willing to give written informed consent according to local guidelines
Who cannot join
- Any treatment with investigational drugs, chemotherapy or immunotherapy within 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiotherapy (1x8 Gy dose) is allowed before and during the study, but not in the week prior to start of study treatment.
- Subjects who have had prior treatment with taxanes.
- Subjects with symptomatic brain metastases. Subjects asymptomatic in the absence of corticosteroids and anticonvulsant therapy for ≥6 weeks are eligible. Radiotherapy for brain metastasis must have been completed ≥6 weeks prior to start of trial. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Subjects are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Subjects with a history of leptomeningeal metastases are not eligible.
- Current malignancies other than mCRPC with exception of adequately treated basal or squamous cell carcinoma of the skin, or adequately treated non-muscular invasive bladder cancer.
- Absence of highly effective method of contraception as of cycle one day one (C1D1). Men enrolled in this trial must agree to use a highly effective contraceptive method throughout the study.
- Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg)
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- Unresolved (>grade 0 as defined by CTCAE version 5.0) gastrointestinal toxicities (pre-existing mucositis, diarrhea or nausea/vomiting)
- Grade ≥ 2 motor ≥ 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5.0)
- Known hypersensitivity to any of the study drugs or excipients or taxanes
- Concomitant use of P-glycoprotein (P-gp , MDR), Cytochrome P450 (CYP)3A, Organic Anion-Transporting Polypeptide (OATP)1B1, OATP1B3 and Multidrug resistance-associated protein 2 (MRP2) modulating drugs such as Ca+- entry blockers (verapamil, dihydropyridines), cyclosporine, quinidine and grapefruit juice, concomitant use of HIV medications, other protease inhibitors, (non) nucleoside analogues, or St. John's wort
- Bowel obstruction or motility disorder that may influence the resorption of drugs as judged by the treating physician
- Major surgical procedures within 21 days prior to providing informed consent
- Active acute or chronic infection, which is not controlled by appropriate medication (at the discretion of the treating physician)
- Known positivity for Human Immunodeficiency Virus HIV-1 or HIV-2 type
- Patients with known active infection of hepatitis B/C (HBC), or E (patients who are anti-HBC positive but HBsAg negative are eligible to participate in this study)
- Clinically significant (i.e. active) cardiovascular disease defined as stroke, transient ischemic attack (TIA), myocardial infarction, unstable angina, or congestive heart failure within ≤ 6 months prior to first trial treatment
- Evidence of any other medical conditions (such as treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, or pulmonary embolism within 4 weeks of randomization, or psychiatric illness, drug or alcohol abuse, physical examination or laboratory findings) that may interfere with the planned treatment, affect subject compliance or place the subject at high risk of treatment-related complications
- Legal incapacity
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
Russia12 sites
Regional State Budgetary Healthcare Institution "Altai regional oncology dispensary"
Barnaul
Limited Liability Company "EVIMED
Chelyabinsk
Regional State Budget Institution "Krasnoyarsk Territorial Clinical Hospital n.a. A.I.Kryzhanovskogo"
Krasnoyarsk
Federal State Institution "Russian Cancer Research Center named after N. N. Blokhin" RAMS
Moscow
CJSC Medical Center "AVICENNA"
Novosibirsk
Federal state budget institution "National medical research radiological center " of the Ministry of healthcare of the Russian Federation, branch - A. Tsyb Medical Radiological Research Center
Obninsk
Clinical Oncological Dispensary of Omsk Region
Omsk
Leningrad Region Onco Dispensary
Saint Petersburg
Limited Liability Company "Klinika Andros [Andros Clinic]"
Saint Petersburg
National medical research center of oncology n.a. N.N. Petrov
Saint Petersburg
Pavlov First Saint Petersburg State Medical University
Saint Petersburg
Sverdlovsk Regional Clinical Hospital No. 1
Yekaterinburg
United States4 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89119
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Providence Cancer Institute
Portland, Oregon, 97213
Hungary4 sites
Orszagos Onkologiai Intezet (National Institute of Oncology)
Budapest, 6000
Debreceni Egyetem Klinikai Központ
Debrecen
Petz Aladár Megyei Oktató Kórház
Győr
Jasz-Nagykun-Szolnok Megyei - Hetenyi Geza Korhaz - Rendelointezet - Onkologiai Kozpont
Szolnok, 9700
Germany3 sites
Universitätsmedizin Göttingen
Göttingen
Studienpraxis Urologie
Nürtingen
Universitätsklinikum Tübingen
Tübingen
Poland3 sites
Przychodnia Lekarska "KOMED"
Konin
Instytut Centrum Zdrowia Matki Polki
Lodz
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw
About this study
Official title: A Multicentre Phase 2b Trial to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC), Suitable for Treatment With a Taxane
This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane.
Read the detailed description
This is an open label 1:1 randomized Phase 2b trial to determine the efficacy and tolerability of oral ModraDoc006/r versus i.v. docetaxel in mCRPC subjects. Cohort 1 will receive i.v. docetaxel at 75 mg/m2 every 3 weeks (Q3W). Cohort 2 will receive 30 mg ModraDoc006 in combination with 200 mg ritonavir in the morning and 20 mg ModraDoc006 in combination with 100 mg ritonavir in the evening (7-12 hours after the morning dose), on Day 1, 8 and 15 of a 21-day cycle (BIDW). All patients will also receive 5 mg oral prednisone twice daily. Treatment in both cohorts will continue until disease progression, unacceptable toxicity, or discontinuation for any other reason. The end of the trial is defined as the time point when all subjects have discontinued trial treatment and have been given follow-up for safety measurements according to the trial assessment schedule.
- Being tested
- Docetaxel in Parenteral Dosage Form, ModraDoc006/r
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel in Parenteral Dosage FormDrug
Also called Taxotere
Treatment with IV docetaxel at 75 mg/m2 given as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily
ModraDoc006/rDrug
Also called oral docetaxel formulation
Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel IV | Active comparator | This study arm will receive docetaxel at 75 mg/m2 given i.v. as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily. Receives: Drug: Docetaxel in Parenteral Dosage Form |
| ModraDoc006/r | Experimental | This cohort will receive ModraDoc006/r 30 mg oral docetaxel in combination with 200 mg ritonavir in the morning and 20 mg oral docetaxel in combination with 100 mg ritonavir in the evening (7-12 hours after the morning dose), on Day 1, 8 and 15 of a 21-day cycle, plus 5 mg oral prednisone twice daily. Receives: Drug: ModraDoc006/r |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression Free Survival (rPFS)
Evaluation of rPFS that will be observed as measured by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, in patients with metastatic prostate cancer after treatment with ModraDoc006/r or docetaxel IV.
Radiographic disease progression was defined by the local assessment of:
- Progressive disease by RECIST v1.1. for soft tissue disease
- Or the appearance of 2 or more new bone lesions on bone scan (PCWG3)
Measured: Time from the date of randomization to the date of the first radiologic progression (per PCWG3 criteria) or death from any cause, whichever occurred first, an average of 1 year.
Secondary outcomes (9)
Adverse Event Profile (Safety)
The hematological and non-hematological safety profile of ModraDoc006/r will be assessed by clinical and laboratory evaluations according to CTCAE v5.0.
Measured: Evaluation of all adverse events during the complete study treatment until 28 days after the last intake, an average of 1 year.
Overall Response Rate (ORR)
Percentage of patients evaluable for radiological response (ERR) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI with best overall response of either Complete Response (CR), i.e. disappearance of all target lesions, or Partial Response (PR), i.e. ≥30% decrease in the sum of the longest diameter of target lesions. PCGW3-modified RECIST 1.1 criteria implements the requirement for confirmation of progression at least 6 weeks later for bone lesions at all measurement time points, and for soft tissue lesions after the first measurement (after 2 months) only. Tumor measurements were scheduled after every 8 treatment weeks for the first 24 weeks (i.e. during Week 9, Week 17 and Week 25) and every 12 weeks thereafter.
Measured: From baseline during the complete study treatment, including follow-up visit 28 days after the last treatment, an average of 1 year.
Disease Control Rate (DCR)
Disease control rate is calculated by the percentage of patients with Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; and Stable Disease (SD), ≤20% increase to <30% decrease in the sum of the longest diameter of target lesions per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI. Disease control rate is presented by treatment group for patients that were evaluable for radiological response for the overall study.
Measured: From baseline through study completion, an average of 1 year
Duration of Response (DOR)
DOR is defined as the median time in months from documentation of first tumor response to the first objective evidence of radiologic progression, as measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI, in the subpopulation of patients experiencing a Complete Response (CR), i.e. Disappearance of all target lesions; and Partial Response (PR), i.e. ≥30% decrease in the sum of the longest diameter of target lesions.
Measured: From baseline through study completion, an average of 1 year
Time to Progression (TTP)
Time to Progression is defined as the time from the date of randomization to the date of the first radiologic progression per PCWG3 criteria.
Measured: Time from the date of randomization to the date of the first radiologic progression, an average of 1 year.
PSA Response Rate
PSA decline of >50% from baseline with confirmatory read ≥3 weeks later, based on the Prostate Cancer Working Group 3 (PCWG3) criteria recommendations.
Measured: From baseline through study completion, an average of 1 year
PSA-PFS
Prostate-Specific Antigen Progression-Free Survival (PSA-PFS) according to Prostate Cancer Working Group 3 (PCWG3) guidance.
Prostate-specific antigen progression was defined as per PCWG3 guidance:
- If a patient presented first a decline from baseline, progression was defined as the first PSA increase that was ≥25% and ≥2 ng/mL above the nadir, and which was confirmed by a consecutive second value ≥3 weeks later that fulfilled the same criteria (i.e., a confirmed rising trend)
- If a patient did not present a decline from baseline, progression was defined as the first PSA increase that was ≥25% and ≥2 ng/mL increased from baseline beyond 12 weeks.
Measured: Time from the date of randomization to the date of the first prostate-specific antigen progression or death from any cause, whichever occurred first, an average of 1 year.
Time to PSA Progression
Time to PSA progression was defined as the time from the date of randomization to the PSA progression as defined by Prostate Cancer Working Group 3 (PCWG3).
Prostate-specific antigen progression was defined as per PCWG3 guidance:
- If a patient presented first a decline from baseline, progression was defined as the first PSA increase that was ≥25% and ≥2 ng/mL above the nadir, and which was confirmed by a consecutive second value ≥3 weeks later that fulfilled the same criteria (i.e., a confirmed rising trend)
- If a patient did not present a decline from baseline, progression was defined as the first PSA increase that was ≥25% and ≥2 ng/mL increased from baseline beyond 12 weeks.
Measured: From baseline through study completion, an average of 1 year
Number of Participants Who Experienced a First Skeletal-Related Event
Number of Participants who Experienced a first Skeletal-Related Event (SRE), i.e. the occurrence of the first skeletal-related event (i.e. radiation therapy or surgery to bone, clinically apparent pathological bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain); from the time of randomisation to the first occurrence.
Note: Due to small number of SREs the median time to SRE was not evaluable in this patient population.
Measured: From baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start17 Jul 2019
- Primary completion29 Nov 2021
- Study completion29 Nov 2021
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.
- 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
- Model description
- One-hundred RECIST 1.1 evaluable patients will be randomized 1:1 to treatment with ModraDoc006/r versus standard i.v. docetaxel. The treatment outcome will be estimated and used as the basis for the design of the future pivotal phase 3 trial. The sample size of 50 evaluable patients per cohort will provide a sufficiently precise point estimate of the primary endpoint radiographic Progression Free Survival (rPFS) in both groups to calculate the sample size for the pivotal study.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modra Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M Keessen, MSc, MBA, Study director, Modra Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028388
- Sponsor's protocol ID
- M18MDP
- Status last verified
- Jan 2024
- First submitted
- 17 Jul 2019
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Phase 2b Trial to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC), Suitable for Treatment With a Taxane
- ClinicalTrials.gov ID
- NCT04028388
- Acronym / sponsor ID
- M18MDP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Modra PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 29 Nov 2021 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane.
Detailed description
This is an open label 1:1 randomized Phase 2b trial to determine the efficacy and tolerability of oral ModraDoc006/r versus i.v. docetaxel in mCRPC subjects. Cohort 1 will receive i.v. docetaxel at 75 mg/m2 every 3 weeks (Q3W). Cohort 2 will receive 30 mg ModraDoc006 in combination with 200 mg ritonavir in the morning and 20 mg ModraDoc006 in combination with 100 mg ritonavir in the evening (7-12 hours after the morning dose), on Day 1, 8 and 15 of a 21-day cycle (BIDW). All patients will also receive 5 mg oral prednisone twice daily. Treatment in both cohorts will continue until disease progression, unacceptable toxicity, or discontinuation for any other reason. The end of the trial is defined as the time point when all subjects have discontinued trial treatment and have been given follow-up for safety measurements according to the trial assessment schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One-hundred RECIST 1.1 evaluable patients will be randomized 1:1 to treatment with ModraDoc006/r versus standard i.v. docetaxel. The treatment outcome will be estimated and used as the basis for the design of the future pivotal phase 3 trial. The sample size of 50 evaluable patients per cohort will provide a sufficiently precise point estimate of the primary endpoint radiographic Progression Free Survival (rPFS) in both groups to calculate the sample size for the pivotal study.
| Arm | Type | Receives |
|---|---|---|
| Docetaxel IV | Active comparator | Drug: Docetaxel in Parenteral Dosage FormThis study arm will receive docetaxel at 75 mg/m2 given i.v. as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily. |
| ModraDoc006/r | Experimental | Drug: ModraDoc006/rThis cohort will receive ModraDoc006/r 30 mg oral docetaxel in combination with 200 mg ritonavir in the morning and 20 mg oral docetaxel in combination with 100 mg ritonavir in the evening (7-12 hours after the morning dose), on Day 1, 8 and 15 of a 21-day cycle, plus 5 mg oral prednisone twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years
- Histologically or cytologically proven prostate cancer with evidence of progressive mCRPC, defined as:
- Measurable tumour lesions, defined as pelvic and/or extra-pelvic nodal lesions ≥1.5 cm in the short axis or visceral lesions ≥1.0 cm in the longest dimensions and measurable according to RECIST v1.1, bone metastasis as evaluated with 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy
- Resolution of toxicity of prior therapy to < grade 2 (except for alopecia), as defined by CTCAE v5.0
- Adequate haematological, renal and hepatic functions:
Key exclusion criteria (18 listed)
- Any treatment with investigational drugs, chemotherapy or immunotherapy within 4 weeks prior to receiving the first dose of investigational treatment. Palliative radiotherapy (1x8 Gy dose) is allowed before and during the study, but not in the week prior to start of study treatment.
- Subjects who have had prior treatment with taxanes.
- Subjects with symptomatic brain metastases. Subjects asymptomatic in the absence of corticosteroids and anticonvulsant therapy for ≥6 weeks are eligible. Radiotherapy for brain metastasis must have been completed ≥6 weeks prior to start of trial. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT completed at screening, demonstrating no current evidence of progressive brain metastases). Subjects are not permitted to receive anti-epileptic drugs or corticosteroid treatment indicated for brain metastasis. Subjects with a history of leptomeningeal metastases are not eligible.
- Current malignancies other than mCRPC with exception of adequately treated basal or squamous cell carcinoma of the skin, or adequately treated non-muscular invasive bladder cancer.
- Absence of highly effective method of contraception as of cycle one day one (C1D1). Men enrolled in this trial must agree to use a highly effective contraceptive method throughout the study.
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 |
|---|---|---|
| Docetaxel in Parenteral Dosage FormAlso: TaxotereTreatment with IV docetaxel at 75 mg/m2 given as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily | Drug | Docetaxel IV |
| ModraDoc006/rAlso: oral docetaxel formulationTreatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets | Drug | ModraDoc006/r |
Primary outcome
Radiographic Progression Free Survival (rPFS)
Time frame: Time from the date of randomization to the date of the first radiologic progression (per PCWG3 criteria) or death from any cause, whichever occurred first, an average of 1 year.
Evaluation of rPFS that will be observed as measured by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria, in patients with metastatic prostate cancer after treatment with ModraDoc006/r or docetaxel IV. Radiographic disease progression was defined by the local assessment of: * Progressive disease by RECIST v1.1. for soft tissue disease * Or the appearance of 2 or more new bone lesions on bone scan (PCWG3)
9 secondary outcomes
Adverse Event Profile (Safety)
Time frame: Evaluation of all adverse events during the complete study treatment until 28 days after the last intake, an average of 1 year.
Overall Response Rate (ORR)
Time frame: From baseline during the complete study treatment, including follow-up visit 28 days after the last treatment, an average of 1 year.
Disease Control Rate (DCR)
Time frame: From baseline through study completion, an average of 1 year
Duration of Response (DOR)
Time frame: From baseline through study completion, an average of 1 year
Time to Progression (TTP)
Time frame: Time from the date of randomization to the date of the first radiologic progression, an average of 1 year.
PSA Response Rate
Time frame: From baseline through study completion, an average of 1 year
PSA-PFS
Time frame: Time from the date of randomization to the date of the first prostate-specific antigen progression or death from any cause, whichever occurred first, an average of 1 year.
Time to PSA Progression
Time frame: From baseline through study completion, an average of 1 year
Number of Participants Who Experienced a First Skeletal-Related Event
Time frame: From baseline through study completion, an average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- 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.
M Keessen, MSc, MBA study director
Modra Pharmaceuticals
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel in Parenteral Dosage Form and ModraDoc006/r in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Modra Pharmaceuticals at 28 sites in 6 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 18 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: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Russia, United States, Hungary, Germany, Poland and 1 more country. 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 17 Apr 2024). 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: Time from the date of randomization to the date of the first radiologic progression (per PCWG3 criteria) or death from any cause, whichever occurred first, an average of 1 year.). 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 17 Apr 2024.