ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

July 17, 2019

Primary Completion Date

November 29, 2021

Study Completion Date

November 29, 2021

Conditions
Prostate Cancer MetastaticCastration-resistant Prostate Cancer
Interventions
DRUG

Docetaxel in Parenteral Dosage Form

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

DRUG

ModraDoc006/r

Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets

Trial Locations (28)

6000

Orszagos Onkologiai Intezet (National Institute of Oncology), Budapest

9700

Jasz-Nagykun-Szolnok Megyei - Hetenyi Geza Korhaz - Rendelointezet - Onkologiai Kozpont, Szolnok

29572

Carolina Urologic Research Center, Myrtle Beach

48201

Karmanos Cancer Institute, Detroit

89119

Comprehensive Cancer Centers of Nevada, Las Vegas

97213

Providence Cancer Institute, Portland

Unknown

Nemocnice Liberec, Liberec

Urologicke oddeleni FTN, Prague

Universitätsmedizin Göttingen, Göttingen

Studienpraxis Urologie, Nürtingen

Universitätsklinikum Tübingen, Tübingen

Debreceni Egyetem Klinikai Központ, Debrecen

Petz Aladár Megyei Oktató Kórház, Győr

"Przychodnia Lekarska KOMED", Konin

Instytut Centrum Zdrowia Matki Polki, Lodz

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie, Warsaw

"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

Sponsors
All Listed Sponsors
lead

Modra Pharmaceuticals

INDUSTRY

NCT04028388 - ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer | Biotech Hunter | Biotech Hunter