docetaxel micellar / Vivesto - LARVOL DELTA

Dose escalation phase Ib trial of a new micellar docetaxel compound in patients with metastatic castration-resistant prostate cancer (mCRPC), SAKK 67/20 (ESMO-TAT 2025) - P1 | "Background: Docetaxel micellar (DM) is a novel formulation of docetaxel, with N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt (XMeNa) as excipient, not requiring pre/post infusional steroids... DM at a 3-weekly dose of 75 and 90 mg/m2 without steroids has a manageable safety profile. Preliminary clinical activity is as expected for docetaxel in mCRPC. The study was prematurely terminated by the sponsor due to strategic decision and slow recruitment."

Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SAKK 67/20: Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Swiss Group for Clinical Cancer Research | Phase classification: P1b ➔ P1 | Trial completion date: Dec 2024 ➔ Jan 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Jan 2024; SAKK decided to premature terminate this trial as additional follow-up visits do not further contribute to the efficacy data. This decision does not adversely impact the patients.

Metastases • Phase classification • Trial completion date • Trial primary completion date • Trial termination • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Vivesto AB Announces Early Termination of Patient Enrollment in the Investigator-Initiated Phase 1B Docetaxel Micellar Study (Market Screener) - "Vivesto AB announced early termination of patient enrollment in the Docetaxel micellar advanced prostate cancer Phase 1b study with the Swiss Group for Clinical Cancer Research (SAKK). The open-label, multicenter, single-stage Phase 1b study has closed its accrual after enrollment of 11 of the planned 18 patients, since Vivesto believes that the data generated will be sufficient ahead of switching into development with a new formulation based on its improved XR-18 micelle technology platform."

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

SAKK 67/20: Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC (clinicaltrials.gov) - P1b | N=11 | Active, not recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Recruiting ➔ Active, not recruiting | N=18 ➔ 11 | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EAU and APCCC session: A focus on mHSPC (European Association of Urology) - "During 'Optimal treatment for high volume de novo patients who are elderly' by Prof. Christopher Sweeney (US), he stated that 'For patients with poor prognosis of three years of ADT (androgen deprivation therapy) alone, with four or more bone metastases and/or visceral metastases, if they're chemofit, I propose trying abiraterone, darolutamide, enzalutamide plus docetaxel. If the patients are not candidates for docetaxel, I propose abiraterone, enzalutamide, and apalutamide.'"

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Choosing AR-Targeted Therapy in CSPC: Monitoring Responses to Novel Hormonal Agents in Metastatic CSPC (Targeted Oncology) - "During a live virtual event, Daniel C. Danila, MD, discussed how to treat a patient with de novo metastatic castration-sensitive prostate cancer and monitor for disease progression....The phase 3 PEACE-1 trial [NCT01957436] presented at the 2021 European Society of Medical Oncology [ESMO] Congress demonstrated that using docetaxel in addition to abiraterone up-front improved overall survival [OS], and that's a great addition to the armamentarium."

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Update on Progress of SAKK Investigator-Initiated Phase 1b trial of Docetaxel Micellar in Advanced Prostate Cancer (Oasmia Press Release) - "Oasmia Pharmaceutical AB (Oasmia)...announces that the first patient has now fully completed the study in the Investigator-Initiated Phase 1b trial of Docetaxel micellar for advanced prostate cancer (trial SAKK 67/20 of the Swiss Group for Clinical Cancer Research SAKK). Furthermore, the first of three dosing groups in the trial has been successfully recruited and the first patient has started in the second dose group."

Enrollment status • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

First Patient enrolled in the SAKK Investigator-Initiated Phase 1b trial of Docetaxel Micellar in Advanced Prostate Cancer (Oasmia Press Release) - “Oasmia Pharmaceutical…announces that the first patient has been dosed in a Phase 1b clinical trial of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer. The trial is being conducted by the Swiss Group for Clinical Cancer Research (SAKK)…The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver and renal function.”

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer

Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC (clinicaltrials.gov) - P1b; N=18; Recruiting; Sponsor: Swiss Group for Clinical Cancer Research; Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC (clinicaltrials.gov) - P1b; N=18; Not yet recruiting; Sponsor: Swiss Group for Clinical Cancer Research

Clinical • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor