Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015
A Phase I/II Trial of BNC105P with Everolimus in Metastatic Renal Cell Carcinoma.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01034631 (Phase I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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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 I/II Study of BNC105P in Combination With Everolimus or Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020Pooled it
- Design, synthesis, and biological evaluation of 6-aryl-3-(3,4,5-trimethoxyphenyl)imidazo[1,2-a]pyridine derivatives as novel tubulin inhibitors with potent anticancer efficacy.Journal of enzyme inhibition and medicinal chemistry · 2026Article
- Synthesis,RSC medicinal chemistry · 2024Article
- Design, synthesis, and bioevaluation of diarylpyrimidine derivatives as novel microtubule destabilizers.Frontiers in chemistry · 2024Article
- Discovery of novel arylamide derivatives containing piperazine moiety as inhibitors of tubulin polymerisation with potent liver cancer inhibitory activity.Journal of enzyme inhibition and medicinal chemistry · 2023Article
- Recent Advances of Tubulin Inhibitors Targeting the Colchicine Binding Site for Cancer Therapy.Biomolecules · 2022Review
- Article
- Non-Invasive Evaluation of Acute Effects of Tubulin Binding Agents: A Review of Imaging Vascular Disruption in Tumors.Molecules (Basel, Switzerland) · 2021Review
- Pharmacological plasticity-How do you hit a moving target?Pharmacology research & perspectives · 2019Review
- Kinase-targeted cancer therapies: progress, challenges and future directions.Molecular cancer · 2018Review
- Article
Corrections and comments
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Authors and funding
22 authors.
Funding
Abstract
purposeBNC105P inhibits tubulin polymerization, and preclinical studies suggest possible synergy with everolimus. In this phase I/II study, efficacy and safety of the combination were explored in patients with metastatic renal cell carcinoma (mRCC). EXPERIMENTAL
designA phase I study in patients with clear cell mRCC and any prior number of therapies was conducted using a classical 3 + 3 design to evaluate standard doses of everolimus with increasing doses of BNC105P. At the recommended phase II dose (RP2D), patients with clear cell mRCC and one to two prior therapies (including ≥ 1 VEGF-TKI) were randomized to BNC105P with everolimus (arm A) or everolimus alone (arm B). The primary endpoint of the study was 6-month progression-free survival (6MPFS). Secondary endpoints included response rate, PFS, overall survival, and exploratory biomarker analyses.
resultsIn the phase I study (N = 15), a dose of BNC105P at 16 mg/m(2) with everolimus at 10 mg daily was identified as the RP2D. In the phase II study, 139 patients were randomized, with 69 and 67 evaluable patients in arms A and B, respectively. 6MPFS was similar in the treatment arms (arm A: 33.82% vs. arm B: 30.30%, P = 0.66) and no difference in median PFS was observed (arm A: 4.7 mos vs. arm B: 4.1 mos; P = 0.49). Changes in matrix metalloproteinase-9, stem cell factor, sex hormone-binding globulin, and serum amyloid A protein were associated with clinical outcome with BNC105P.
conclusionsAlthough the primary endpoint was not met in an unselected population, correlative studies suggest several biomarkers that warrant further prospective evaluation.
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