A multicentre Phase IIb 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.

Modra Pharmaceuticals B.V.0 sites100 target enrollmentApril 25, 2019

Conditionsmetastatic Castration Resistant Prostate Cancer MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsNorvir Docetaxel

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: metastatic Castration Resistant Prostate Cancer
Sponsor: Modra Pharmaceuticals B.V.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 25, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Modra Pharmaceuticals B.V.

Eligibility Criteria

Inclusion Criteria

•1\. Age \= 18 years
•2\. Histologically or cytologically proven prostate cancer with evidence of progressive mCRPC, defined as:
•a. Castrate levels of testosterone, defined as \= 50 ng/dL (or \= 0\.50 ng/mL or 1\.73 nmol/L)
•b. Evidence of progressive metastatic disease as defined by radiographic disease progression or PSA progression
•c. With an indication for systemic treatment with docetaxel according to the standard of care
•3\. 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
•4\. Resolution of toxicity of prior therapy to \< grade 2 (except for alopecia), as defined by CTCAE v5\.0
•5\. Adequate haematological, renal and hepatic functions:
•a. Haemoglobin \= 6\.0 mmol/l (\>9\.6 g/dL)
•b. ANC \= 1\.5 x 109 /L

Exclusion Criteria

•1\. 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.
•2\. Subjects who have had prior treatment with taxanes.
•3\. 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.
•4\. 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.
•5\. 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.
•6\. Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg)
•7\. Unresolved (\>grade 0 as defined by CTCAE version 5\.0\) gastrointestinal toxicities (pre\-existing mucositis, diarrhea or nausea/vomiting)
•8\. Grade \= 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5\.0\)
•9\. Known hypersensitivity to any of the study drugs or excipients or taxanes
•10\. Concomitant use of P\-glycoprotein (P\-gp , MDR), CYP3A, OATP1B1, OATP1B3 and 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