We are analyzing https://link.springer.com/article/10.1007/s10637-015-0235-5.

Title:
AZD3514, an oral selective androgen receptor down-regulator in patients with castration-resistant prostate cancer – results of two parallel first-in-human phase I studies | Investigational New Drugs
Description:
Background AZD3514 is a first-in-class, orally bio-available, androgen-dependent and -independent androgen receptor inhibitor and selective androgen-receptor down-regulator (SARD). Methods In study 1 and 2, castration-resistant prostate cancer (CRPC) patients (pts) were initially recruited into a once daily (QD) oral schedule (A). In study 1, pharmacokinetic assessments led to twice daily (BID) dosing (schedule B) to increase exposure. Study 2 explored a once daily schedule. Results In study 1, 49 pts were treated with escalating doses of AZD3514 (A 35 pts, B 14 pts). Starting doses were 100 mg (A) and 1000 mg (B). The AZD3514 formulation was switched from capsules to tablets at 1000 mg QD. 2000 mg BID was considered non-tolerable due to grade (G) 2 toxicities (nausea [N], vomiting [V]). No adverse events (AEs) met the dose-limiting toxicity (DLT) definition. Thirteen pts received AZD3514 in study 2, with starting doses of 250 mg QD. The most frequent drug-related AEs were N: G1/2 in 55/70 pts (79 %); G3 in 1 pt (1.4 %); & V: G1/2 in 34/70 pts (49 %) & G3 in 1 pt (1.4 %). PSA declines (≥50 %) were documented in 9/70 patients (13 %). Objective soft tissue responses per RECIST1.1 were observed in 4/24 (17 %) pts in study 1. Conclusion AZD3514 has moderate anti-tumour activity in pts with advanced CRPC but with significant levels of nausea and vomiting. However, anti-tumour activity as judged by significant PSA declines, objective responses and durable disease stabilisations, provides the rationale for future development of SARD compounds.
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Keywords {🔍}

cancer, prostate, article, google, scholar, pubmed, receptor, androgen, research, castrationresistant, azd, study, astrazeneca, patients, bono, metastatic, clin, cas, pts, abiraterone, central, enzalutamide, oncol, phase, med, jones, res, activity, access, resistance, grant, astellas, janssen, privacy, cookies, content, downregulator, chemotherapy, fizazi, scher, engl, doinejmoa, eur, sanofi, institute, publish, search, drugs, selective, results,

Topics {✒️}

castration-resistant prostate cancer month download article/chapter frequent drug-related aes moderate anti-tumour activity metastatic prostate cancer overcoming mutation-based resistance selective androgen-receptor prostate cancer foundation androgen-directed therapy full article pdf anti-tumour activity dna binding domain mutant androgen receptor related subjects bradbury rh progressive prostate cancer treating prostate cancer advanced prostate cancer prostate cancer uk privacy choices/manage cookies drug development unit loddick sa cancer cell 16 full-length receptor akt inhibitor azd5363 scotland cancer centre rational drug design biomedical research grant cancer research uk beer tm swiss cancer league article investigational de bono js kitasato university school clin cancer res androgen receptor netherlands cancer institute european economic area scope submit manuscript pharmacokinetic assessments led dose-limiting toxicity durable disease stabilisations anti-tumor activity steroid hormone receptors goodman ob jr response evaluation criteria revised recist guideline tumor cells circulate ken-ichi tabata received consulting fees

Questions {❓}

Attard G, Cooper CS, de Bono JS (2009) Steroid hormone receptors in prostate cancer: a hard habit to break?

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         headline:AZD3514, an oral selective androgen receptor down-regulator in patients with castration-resistant prostate cancer – results of two parallel first-in-human phase I studies
         description: Background AZD3514 is a first-in-class, orally bio-available, androgen-dependent and -independent androgen receptor inhibitor and selective androgen-receptor down-regulator (SARD). Methods In study 1 and 2, castration-resistant prostate cancer (CRPC) patients (pts) were initially recruited into a once daily (QD) oral schedule (A). In study 1, pharmacokinetic assessments led to twice daily (BID) dosing (schedule B) to increase exposure. Study 2 explored a once daily schedule. Results In study 1, 49 pts were treated with escalating doses of AZD3514 (A 35 pts, B 14 pts). Starting doses were 100 mg (A) and 1000 mg (B). The AZD3514 formulation was switched from capsules to tablets at 1000 mg QD. 2000 mg BID was considered non-tolerable due to grade (G) 2 toxicities (nausea [N], vomiting [V]). No adverse events (AEs) met the dose-limiting toxicity (DLT) definition. Thirteen pts received AZD3514 in study 2, with starting doses of 250 mg QD. The most frequent drug-related AEs were N: G1/2 in 55/70 pts (79 %); G3 in 1 pt (1.4 %); & V: G1/2 in 34/70 pts (49 %) & G3 in 1 pt (1.4 %). PSA declines (≥50 %) were documented in 9/70 patients (13 %). Objective soft tissue responses per RECIST1.1 were observed in 4/24 (17 %) pts in study 1. Conclusion AZD3514 has moderate anti-tumour activity in pts with advanced CRPC but with significant levels of nausea and vomiting. However, anti-tumour activity as judged by significant PSA declines, objective responses and durable disease stabilisations, provides the rationale for future development of SARD compounds.
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            (5) Castration-resistant prostate cancer
            Phase I
            First-in-human
            AZD3514
            Selective androgen receptor down-regulator
            Oncology
            Pharmacology/Toxicology
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      headline:AZD3514, an oral selective androgen receptor down-regulator in patients with castration-resistant prostate cancer – results of two parallel first-in-human phase I studies
      description: Background AZD3514 is a first-in-class, orally bio-available, androgen-dependent and -independent androgen receptor inhibitor and selective androgen-receptor down-regulator (SARD). Methods In study 1 and 2, castration-resistant prostate cancer (CRPC) patients (pts) were initially recruited into a once daily (QD) oral schedule (A). In study 1, pharmacokinetic assessments led to twice daily (BID) dosing (schedule B) to increase exposure. Study 2 explored a once daily schedule. Results In study 1, 49 pts were treated with escalating doses of AZD3514 (A 35 pts, B 14 pts). Starting doses were 100 mg (A) and 1000 mg (B). The AZD3514 formulation was switched from capsules to tablets at 1000 mg QD. 2000 mg BID was considered non-tolerable due to grade (G) 2 toxicities (nausea [N], vomiting [V]). No adverse events (AEs) met the dose-limiting toxicity (DLT) definition. Thirteen pts received AZD3514 in study 2, with starting doses of 250 mg QD. The most frequent drug-related AEs were N: G1/2 in 55/70 pts (79 %); G3 in 1 pt (1.4 %); & V: G1/2 in 34/70 pts (49 %) & G3 in 1 pt (1.4 %). PSA declines (≥50 %) were documented in 9/70 patients (13 %). Objective soft tissue responses per RECIST1.1 were observed in 4/24 (17 %) pts in study 1. Conclusion AZD3514 has moderate anti-tumour activity in pts with advanced CRPC but with significant levels of nausea and vomiting. However, anti-tumour activity as judged by significant PSA declines, objective responses and durable disease stabilisations, provides the rationale for future development of SARD compounds.
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      dateModified:2015-04-30T00:00:00Z
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      pageEnd:690
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         (5) Castration-resistant prostate cancer
         Phase I
         First-in-human
         AZD3514
         Selective androgen receptor down-regulator
         Oncology
         Pharmacology/Toxicology
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                     name:Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht, The Netherlands
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