- |||||||||| Herceptin (trastuzumab) / Roche
Journal: Genomic characteristics of trastuzumab-resistant Her2-positive metastatic breast cancer. (Pubmed Central) - Sep 21, 2017 Mutational burden in heavily treated trastuzumab-resistant Her2-positive metastatic breast cancer is highly variable and not directly correlated with outcome. Activation of the MAPK/ERK pathway through mutations in EGFR, BRAF or KIT may mediate resistance to trastuzumab.
- |||||||||| everolimus / Generic mfg., Torisel (temsirolimus) / Pfizer
Biomarker, Review, Journal: Phosphoinositide 3-kinase (PI3K) pathway inhibitors in solid tumors: From laboratory to patients. (Pubmed Central) - Sep 21, 2017 Challenges to the therapeutic effectiveness of some PI3K inhibitors include the absence of reliable and effective biomarkers, their limited efficacy as single agents, insufficient development of rational therapeutic combinations, the use of schedules with a variety of off-target effects, and suboptimal therapeutic exposures. Therefore, with regard to PI3K inhibitors currently in late-stage clinical trials, the identification of appropriate biomarkers of efficacy and the development of optimal combination regimens and dosing schedules are likely to be important for graduation into clinical practice.
- |||||||||| everolimus / Generic mfg., fulvestrant / Generic mfg.
Trial completion, Metastases: Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI (clinicaltrials.gov) - Sep 14, 2017 P2, N=131, Completed, Therefore, with regard to PI3K inhibitors currently in late-stage clinical trials, the identification of appropriate biomarkers of efficacy and the development of optimal combination regimens and dosing schedules are likely to be important for graduation into clinical practice. Active, not recruiting --> Completed
- |||||||||| Trial primary completion date, Gene Expression Profile, IO biomarker, Biopsy, Post-transplantation: Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens (clinicaltrials.gov) - Sep 13, 2017
P=N/A, N=88, Active, not recruiting, Active, not recruiting --> Completed Trial primary completion date: May 2017 --> May 2020
- |||||||||| Biomarker, Review, Journal: Current Management Strategy for Metastatic Renal Cell Carcinoma and Future Directions. (Pubmed Central) - Sep 8, 2017
Most recently, several new drugs including nivolumab, cabozantinib, and a combination of lenvatinib and everolimus have demonstrated acceptable toxicity and significantly improved overall survival, but evidence-based guidelines for sequencing of the approved treatment options and treatment selection based on biomarkers are still missing...Several ongoing clinical trials are evaluating sequencing, timing of cytoreductive nephrectomy, combinations of immunotherapies and targeted therapies as well as selection of the best systemic treatment. Personalized treatment based on tumor profiling is one of the brightest spots on the horizon.
- |||||||||| everolimus / Generic mfg.
Biomarker, Enrollment open, Enrollment change, Trial primary completion date: PEARL: Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women (clinicaltrials.gov) - Sep 5, 2017 P2, N=46, Recruiting, Active, not recruiting --> Completed Active, not recruiting --> Recruiting | N=130 --> 46 | Trial primary completion date: Oct 2016 --> Jun 2018
- |||||||||| vistusertib (AZD2014) / AstraZeneca
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: MANTA: A Randomized Study of AZD2014 in Combination With Fulvestrant in Metastatic or Advanced Breast Cancer (clinicaltrials.gov) - Aug 28, 2017 P2, N=333, Active, not recruiting, Active, not recruiting --> Recruiting | N=130 --> 46 | Trial primary completion date: Oct 2016 --> Jun 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2016 --> Jun 2019
- |||||||||| Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen
Review, Journal: Cabozantinib use in renal cell carcinoma. (Pubmed Central) - Aug 26, 2017 This agent's toxicity profile is similar to those of other multikinase inhibitors approved to treat RCC. This review will explore cabozantinib's pharmacologic and safety profile and its preclinical and clinical activity in RCC.
- |||||||||| dactolisib (RTB101) / Adicet Bio
Phase classification, Enrollment change, Trial termination, Trial primary completion date, Metastases: Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Aug 23, 2017 P1b, N=19, Terminated, Active, not recruiting --> Recruiting Phase classification: P1/2 --> P1b | N=54 --> 19 | Recruiting --> Terminated | Trial primary completion date: Dec 2014 --> Feb 2014; funding
- |||||||||| Avastin (bevacizumab) / Roche
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy, Metastases: IMPROVE: Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab (clinicaltrials.gov) - Aug 23, 2017 P4, N=77, Active, not recruiting, Phase classification: P1/2 --> P1b | N=54 --> 19 | Recruiting --> Terminated | Trial primary completion date: Dec 2014 --> Feb 2014; funding Recruiting --> Active, not recruiting | N=192 --> 77 | Trial primary completion date: Dec 2018 --> Aug 2017
- |||||||||| everolimus / Generic mfg.
Trial primary completion date: Everolimus Post Orthotopic Liver Transplant (clinicaltrials.gov) - Aug 10, 2017 P2, N=50, Recruiting, Prophylactic use of dexamethasone oral solution substantially reduced the incidence and severity of stomatitis in patients receiving everolimus and exemestane and could be a new standard of oral care for patients receiving everolimus and exemestane therapy. Trial primary completion date: Oct 2016 --> Jun 2018
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Trial completion, Trial primary completion date: Everolimus, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Untreated Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Aug 10, 2017 P1, N=26, Completed, Trial primary completion date: Oct 2016 --> Jun 2018 Active, not recruiting --> Completed | Trial primary completion date: Feb 2020 --> Feb 2015
- |||||||||| Review, Journal: Advanced Hepatocellular Cancer: the Current State of Future Research. (Pubmed Central) - Aug 10, 2017
Currently, sorafenib remains the only established systemic therapy proven to increase the overall survival of patients with advanced disease...Having reached somewhat of an impasse in terms of drug development in hepatocellular carcinoma, enthusiasm in the field has moved toward innovative approaches such as molecular characterization and immunotherapy in an attempt to impact survival. This review highlights the current endeavors in terms of experimental research for patients with advanced hepatocellular carcinoma.
- |||||||||| everolimus / Generic mfg., vinorelbine tartrate / Generic mfg.
Trial completion, Trial primary completion date, Combination therapy, Monotherapy, Metastases: VicTORia: Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer (clinicaltrials.gov) - Aug 9, 2017 P2, N=139, Completed, This review highlights the current endeavors in terms of experimental research for patients with advanced hepatocellular carcinoma. Active, not recruiting --> Completed | Trial primary completion date: Feb 2017 --> Oct 2016
- |||||||||| letrozole / Generic mfg., tamoxifen / Generic mfg., everolimus / Generic mfg.
Trial primary completion date, Metastases: Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer (clinicaltrials.gov) - Aug 9, 2017 P2, N=74, Active, not recruiting, Active, not recruiting --> Completed | Trial primary completion date: Feb 2017 --> Oct 2016 Trial primary completion date: Dec 2016 --> Jun 2017
- |||||||||| Enrollment change, Trial termination, Trial primary completion date: Personalized Targeted Inhibitors Treatment in Renal Cell Cancer (clinicaltrials.gov) - Aug 3, 2017
P2, N=4, Terminated, Trial primary completion date: Jul 2016 --> Nov 2017 N=100 --> 4 | Recruiting --> Terminated | Trial primary completion date: Dec 2018 --> Jul 2017; Loss of laboratory performing molecular analysis
- |||||||||| carboplatin / Generic mfg., everolimus / Generic mfg., paclitaxel / Generic mfg.
Trial primary completion date, Metastases: Gastric Cancer RAD001 Study (clinicaltrials.gov) - Jul 28, 2017 P1/2, N=35, Active, not recruiting, Prospective studies will be needed to verify these results. Trial primary completion date: Jun 2017 --> Dec 2017
- |||||||||| everolimus / Generic mfg., paclitaxel / Generic mfg.
Trial primary completion date, Metastases: First-line Everolimus +/- Paclitaxel for Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma (clinicaltrials.gov) - Jul 26, 2017 P2, N=36, Active, not recruiting, Navigating the current therapeutic algorithm may be challenging, and requires an understanding both of the heterogeneity of NETs and of characteristics that are shared by NETs across tumor subtypes. Trial primary completion date: Jun 2017 --> Oct 2017
- |||||||||| Ibrance (palbociclib) / Pfizer, everolimus / Generic mfg., fulvestrant / Generic mfg.
Biomarker, Journal: Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline. (Pubmed Central) - Jul 24, 2017 The mammalian target of rapamycin inhibitor everolimus may be administered with exemestane to postmenopausal women with MBC whose disease progresses while receiving nonsteroidal AIs. Among patients with HR-positive, human epidermal growth factor receptor 2-positive MBC, human epidermal growth factor receptor 2-targeted therapy plus an AI can be effective for those who are not chemotherapy candidates.
- |||||||||| everolimus / Generic mfg.
Enrollment closed, Enrollment change, IO biomarker: Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas (clinicaltrials.gov) - Jul 24, 2017 P, N=5, Active, not recruiting, Among patients with HR-positive, human epidermal growth factor receptor 2-positive MBC, human epidermal growth factor receptor 2-targeted therapy plus an AI can be effective for those who are not chemotherapy candidates. Recruiting --> Active, not recruiting | N=51 --> 5
- |||||||||| Mekinist (trametinib) / Novartis, BeiGene
Enrollment closed, Trial primary completion date: GSK1120212 Rollover Study (clinicaltrials.gov) - Jul 24, 2017 P2, N=250, Active, not recruiting, Recruiting --> Active, not recruiting | N=51 --> 5 Recruiting --> Active, not recruiting | Trial primary completion date: Jun 2018 --> Aug 2017
|