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Chemotherapy

ModraDoc006/r for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Modra Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug combo to see if it's effective and has few side effects in treating men with metastatic prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression Free Survival (rPFS)
Secondary study objectives
Adverse Event Profile (Safety)
Disease Control Rate (DCR)
Duration of Response (DOR)
+6 more
Other study objectives
Overall Health-Related Quality of Life Response
Overall Health-Related Utility
Summary of Improvement by Individual Health- Related Quality of Life Domains
+1 more

Side effects data

From 2021 Phase 2 trial • 135 Patients • NCT04028388
43%
Alopecia
27%
Fatigue
27%
Anemia
24%
Diarrhoea
22%
Neutropenia
18%
Nausea
14%
Dypnoea
12%
Leukopenia
12%
Neuropathy peripheral
12%
Oedema peripheral
10%
Back pain
8%
Nail disorder
8%
Hypoaesthesia
8%
Asthenia
8%
Stomatitis
6%
Dry skin
6%
Constipation
6%
Weight decreased
6%
Extravasation
6%
Cough
6%
Corona virus infection
6%
Musculoskeletal pain
6%
Decreased appetite
4%
Muscular weakness
4%
Aspartate aminotransferase increased
4%
Alanine aminotransferase increased
4%
Gamma-glutamyltransferase increased
2%
Dehydration
2%
Pyrexia
2%
Headache
2%
Thrombocytopenia
2%
Bone pain
2%
Bronchitis
2%
Erysipelas
2%
Cellulitis
2%
Peripheral swelling
2%
Osteomyelitis
2%
Hypocalcaemia
2%
Muscle spasms
2%
Dental caries
2%
Sepsis
2%
Peripheral sensory neuropathy
2%
Pneumonia viral (Covid-19)
2%
Blood lactate dehydrogenase increased
2%
Dysgeusia
2%
Pulmonary embolism
2%
Escherichia urinary tract infection
2%
Orthostatic hypotension
2%
Prostate cancer
2%
Death
2%
Peptic ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel IV
ModraDoc006/r

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ModraDoc006/rExperimental Treatment1 Intervention
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.
Group II: Docetaxel IVActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ModraDoc006/r
2017
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

Modra PharmaceuticalsLead Sponsor
6 Previous Clinical Trials
70 Total Patients Enrolled
EJ DeWit, MDStudy DirectorModra Pharmaceuticals
M Keessen, MSc, MBAStudy DirectorModra Pharmaceuticals
~22 spots leftby Oct 2025
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