Trial reportInvestigational new drugs2012
A phase II study of 2-methoxyestradiol nanocrystal colloidal dispersion alone and in combination with sunitinib malate in patients with metastatic renal cell carcinoma progressing on sunitinib malate.
Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00444314 (Phase II Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion Alone and in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma Progressing on Sunitinib Malate), which is not on this map. Cited by 47 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Study of 2-Methoxyestradiol Nanocrystal Colloidal Dispersion Alone and in Combination With Sunitinib Malate in Patients With Metastatic Renal Cell Carcinoma Progressing on Sunitinib Malate
Who cites it
47 citing papers in PubMed, 1 synthesis or guideline pooled it, 89 citations in OpenAlex.
- Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib.Journal of the National Cancer Institute · 2016Pooled it
- Glycolysis modulation: New therapeutic strategies to improve pulmonary hypertension (Review).International journal of molecular medicine · 2024Review
- Inhibition of STAT3 by 2-Methoxyestradiol suppresses M2 polarization and protumoral functions of macrophages in breast cancer.BMC cancer · 2024Article
- Trends in research on nanomedicine in urologic cancer: a bibliometric and visualized analysis.Discover oncology · 2024Article
- Modulation of hypoxia-inducible factor-1 signaling pathways in cancer angiogenesis, invasion, and metastasis by natural compounds: a comprehensive and critical review.Cancer metastasis reviews · 2024Review
- The Interplay Between HIF-1α and EZH2 in Lung Cancer and Dual-Targeted Drug Therapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Article
- 2-Methoxyestradiol and Hydrogen Peroxide as Promising Biomarkers in Parkinson's Disease.Molecular neurobiology · 2024Article
- Review
- HIF: a master regulator of nutrient availability and metabolic cross-talk in the tumor microenvironment.The EMBO journal · 2023Review
- The hypoxia-inducible factor-1α in stemness and resistance to chemotherapy in gastric cancer: Future directions for therapeutic targeting.Frontiers in cell and developmental biology · 2023Review
- 2-Difluoromethoxy-Substituted Estratriene Sulfamates: Synthesis, Antiproliferative SAR, Antitubulin Activity, and Steroid Sulfatase Inhibition.ChemMedChem · 2022Article
- 2-Methoxyestradiol Damages DNA in Glioblastoma Cells by Regulating nNOS and Heat Shock Proteins.Antioxidants (Basel, Switzerland) · 2022Article
- Review of potential medical treatments for middle ear cholesteatoma.Cell communication and signaling : CCS · 2022Review
- Self-Nanoemulsifying Drug Delivery System of 2-Methoxyestradiol Exhibits Enhanced Anti-Proliferative and Pro-Apoptotic Activities in MCF-7 Breast Cancer Cells.Life (Basel, Switzerland) · 2022Article
- 2-Methoxyestradiol TPGS Micelles Attenuate Cyclosporine A-Induced Nephrotoxicity in Rats through Inhibition of TGF-β1 and p-ERK1/2 Axis.Antioxidants (Basel, Switzerland) · 2022Article
- The role of hypoxia-inducible factor-1 alpha in multidrug-resistant breast cancer.Frontiers in oncology · 2022Review
- Targeting immune cell metabolism in kidney diseases.Nature reviews. Nephrology · 2021Review
- Regulation of mitochondrial dynamics in 2-methoxyestradiol-mediated osteosarcoma cell death.Scientific reports · 2021Article
- Involvement of DNA methyltransferase 1 (DNMT1) and multidrug resistance-associated proteins in 2-methoxyestradiol-induced cytotoxicity in EC109/Taxol cells.Translational cancer research · 2021Article
- HIF-1α Is a Rational Target for Future Ovarian Cancer Therapies.Frontiers in oncology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundCurrent treatment for metastatic renal cell cancer with vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI) have provided improved overall survival, but complete responses are rare. We conducted a multicenter phase II study to evaluate the objective response rate of 2-methoxyestradiol (2ME2 NCD) alone and in combination with sunitinib for patients with metastatic renal cell carcinoma who have progressed on sunitinib alone.
methodsAdults with metastatic kidney cancer were stratified depending on whether they were still taking sunitinib or had discontinued sunitinib therapy at the time of registration. Patients were treated with 2ME2 NCD alone or in combination with sunitinib. The primary endpoint was objective response rate.
resultsIn total, 17 patients were enrolled, and 12 were evaluable for response (arm A, n = 7; arm b, n = 5). In arm A, four patients had the best response of stable disease, and three patients developed disease progression. In arm B, three patients had a best response of stable disease, and two patients had disease progression. One patient continued to receive treatment for a total of 14 cycles before developing disease progression. Fatigue was the most common observed toxicities. Thirty five percent of patients required discontinuation of therapy secondary to toxicities.
conclusions2ME2 NCD had minimal anti-tumor activity, with no observed objective responses. The study was terminated because 2ME2 NCD was not found to be tolerable at the recommended phase 2 dose in this patient population. A newer 2ME2 analog is in development with a more favorable toxicity profile and increased potency.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.