- |||||||||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: Reverse Engineering the 1-Month Lupron Depot®. (Pubmed Central) - Sep 26, 2019 Very low content of residual moisture (< 0.5%) and methylene chloride (< 1 ppm) in the product indicates in-water drying is capable of removing solvents to extremely low levels during manufacturing. The rigorous approach of reverse engineering described here may be useful for development of generic leuprolide-PLGA microspheres as well as other new and generic PLGA microsphere formulations.
- |||||||||| NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (clinicaltrials.gov) - Sep 26, 2019 P=N/A, N=72, Recruiting, The rigorous approach of reverse engineering described here may be useful for development of generic leuprolide-PLGA microspheres as well as other new and generic PLGA microsphere formulations. Trial completion date: Aug 2019 --> Aug 2020 | Trial primary completion date: Aug 2019 --> Aug 2020
- |||||||||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Prostate Cancer in an Incarcerated Population: Patient Characteristics and Treatment (ASTRO Innovation Hub) - Sep 24, 2019 - Abstract #ASTRO2019ASTRO_3712; As no prostate screening system is in place ,these more advanced malignancies likely represent the natural history of an unscreened population, which also appears to be the trend in the general population. All incarcerated patients in this study have been treated as per national guidelines.
- |||||||||| sunitinib / Generic mfg.
Trial completion date, Trial primary completion date: Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy (clinicaltrials.gov) - Sep 18, 2019 P2, N=64, Active, not recruiting, Trial completion date: Jul 2021 --> Oct 2021 | Trial primary completion date: Jul 2021 --> Oct 2021 Trial completion date: May 2019 --> Dec 2019 | Trial primary completion date: May 2019 --> Dec 2019
- |||||||||| Erleada (apalutamide) / J&J
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer (clinicaltrials.gov) - Sep 16, 2019 P2, N=9, Active, not recruiting, Trial completion date: May 2019 --> Dec 2019 | Trial primary completion date: May 2019 --> Dec 2019 Recruiting --> Active, not recruiting | N=33 --> 9 | Trial completion date: Aug 2024 --> Dec 2019 | Trial primary completion date: Aug 2020 --> May 2019
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., anastrozole / Generic mfg., testosterone gel / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date: Regulation of Cortisol Metabolism and Fat Patterning (clinicaltrials.gov) - Aug 7, 2019 P=N/A, N=140, Active, not recruiting, Trial completion date: Jul 2019 --> Jul 2020 | Trial primary completion date: Jul 2019 --> Jul 2020 Completed --> Active, not recruiting | Trial completion date: Sep 2009 --> Sep 2020 | Trial primary completion date: Mar 2009 --> Mar 2020
- |||||||||| Piqray (alpelisib) / Novartis
Trial completion date, Trial primary completion date, Metastases: BYLieve: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (clinicaltrials.gov) - Jul 9, 2019 P2, N=340, Recruiting, Trial primary completion date: Oct 2019 --> Feb 2021 Trial completion date: Sep 2020 --> Nov 2021 | Trial primary completion date: Apr 2020 --> Nov 2020
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., bicalutamide / Generic mfg.
New trial: Defining Recurrent Disease With Axumin (clinicaltrials.gov) - Jun 24, 2019 P, N=20, Recruiting,
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., docetaxel / Generic mfg.
Trial completion date, Trial primary completion date: A Registry for Patients Treated on the Clinical Trial TAX 3503 (clinicaltrials.gov) - Jun 14, 2019 P3, N=52, Active, not recruiting, Recruiting --> Active, not recruiting Trial completion date: Mar 2019 --> Mar 2020 | Trial primary completion date: Mar 2019 --> Mar 2020
- |||||||||| Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date: c15-164: AASUR in High Risk Prostate Cancer (clinicaltrials.gov) - Jun 14, 2019 P2, N=58, Recruiting, Trial completion date: Mar 2019 --> Mar 2020 | Trial primary completion date: Mar 2019 --> Mar 2020 Trial completion date: May 2019 --> May 2020 | Trial primary completion date: May 2019 --> May 2020
- |||||||||| NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date, Metastases: oligo-mets: A Study of Definitive Therapy to Treat Prostate Cancer (clinicaltrials.gov) - Jun 5, 2019 P2, N=33, Recruiting, Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2024 Trial completion date: Mar 2021 --> Apr 2024 | Trial primary completion date: Mar 2019 --> Apr 2022
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Enrollment change, Trial termination: DUALTRIGGER: Study of Dual Trigger Ovulation in Oocyte Donors (clinicaltrials.gov) - May 22, 2019 P4, N=26, Terminated, Trial primary completion date: Mar 2019 --> Oct 2019 N=180 --> 26 | Recruiting --> Terminated; Unable to complete accrual
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