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Clinical Trials, and HPO
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Navigate: Correlations HPO
There is one clinical trial.
ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC). The investigators will be investigating the safety and toxicity of the combination.
Description: The maximum dose at which no more than 1 of 6 patients at same dose level experience a drug related toxicity (DLT), as defined in the protocol.
Measure: Establish the maximum tolerated dose (MTD) in Phase I of AZD5069 administered in combination with enzalutamide at 160mg OD. Time: 12 monthsDescription: Prostate specific antigen (PSA) decline ≥ 50% criteria confirmed 4 weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or, ONLY for patients with detectable circulating tumour cell count (CTC) of ≥ 5/7.5ml blood at baseline, conversion of CTC <5/7.5ml blood nadir.
Measure: Antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase II Time: 12 monthsDescription: For disease progression (see section 3.6) the Prostate Cancer Working Group 2 (PCWG2) criteria and RECIST (v1.1) criteria will be used. Treatment failure will be defined as: Progression of soft tissue/visceral disease by RECIST (v1.1) and/or, Progression of bone disease by PCWG2 bone scan criteria and/or Progression of PSA by PCWG2 PSA criteria.
Measure: Antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase II Time: 12 monthsDescription: Maximal PSA decline at any time during the trial and PSA decline after 12 weeks (as per PCWG2 criteria) of combination treatment.
Measure: PSA decline Time: 24 monthsDescription: Overall survival will be measured from the date of AZD5069 addition to enzalutamide to the date of death (whatever cause). Survival time of living patients will be censored on the last date of patient is known to be alive or lost to follow up.
Measure: Overall survival of patients in Phase II Time: 24 monthsDescription: rPFS will be measured from the date of AZD5069 addition to enzalutamide until: Progression of soft tissue/visceral disease by RESIST and/or, Progression of bone disease by PCWG2 bone scan criteria and/or, Death of any cause Patients withdrawn for any reason prior to radiological progression then the patient should be assessed until radiological progression has occurred. If however they have started another treatment then they will be censored at the start of the new treatment.
Measure: To estimate the radiologic progression free survival (rPFS) on the combination in Phase II Time: 24 monthsDescription: CTC fall by >30% will be expressed as the proportion of patients that have demonstrated a CTC fall of >30% after 12 weeks of combination treatment.
Measure: To assess the effects of AZD5069 and enzalutamide on the number of circulating tumour cells in Phase II Time: 24 monthsDescription: Recording the population exposure to the AZD5069 and enzalutamide combination will summarise safety. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Measure: To further evaluate the safety and tolerability of the combination in patients who progress on enzalutamide in Phase II Time: 24 monthsDescription: Number of patients with a neutrophil to lymphocyte ratio (NLR) ≥ 3 (at baseline) that convert to an NLR < 3 (blood nadir) with AZD5069 and enzalutamide in combination.
Measure: To further characterise the PD profile of AZD5069 and enzalutamide when administered in combination in Phase II Time: 24 monthsDescription: Plasma concentration of enzalutamide and AZD5069 in whole blood
Measure: To characterise the pharmacokinetic (PK) profile of enzalutamide and AZD5069 when administered in combination in Phase I Time: 24 monthsDescription: Number of patients with a neutrophil to lymphocyte ratio (NLR) ≥ 3 (at baseline) that convert to an NLR < 3 (blood nadir) with AZD5069 and enzalutamide in combination.
Measure: To characterise the pharmacodynamic (PD) profile of AZD5069 and enzalutamide when administered in combination in Phase I Time: 24 monthsDescription: Antitumour activity will be defined by response rate on the basis of the following outcomes; if any of these occur, patients will be considered to have responded: PSA decline ≥ 50% criteria confirmed 4 weeks or later and/or, Confirmed soft tissue objective response by RECIST (v1.1) in patients with measurable disease and/or, ONLY for patients with detectable circulating tumour cell count (CTC) of ≥ 5/7.5ml blood at baseline, conversion of CTC <5/7.5ml blood nadir.
Measure: To estimate the antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase I. Time: 24 monthsDescription: Number of patients patients whose circulating myeloid derived suppressor cells (MDSCs) and intratumoral MDSCs reduce by 50% with AZD5069 and enzalutamide in combination.
Measure: To further characterise the PD profile of AZD5069 and enzalutamide when administered in combination in Phase II Time: 24 monthsDescription: Number of patients whose circulating myeloid derived suppressor cells (MDSCs) and intratumoral MDSCs reduce by 50% with AZD5069 and enzalutamide in combination.
Measure: To characterise the pharmacodynamic (PD) profile of AZD5069 and enzalutamide when administered in combination in Phase I Time: 24 monthsDescription: For disease progression (see section 3.6) the PCWG2 criteria and RECIST (v1.1) criteria will be used. Treatment failure will be defined as: Progression of soft tissue/visceral disease by RECIST (v1.1) and/or, Progression of bone disease by PCWG2 bone scan criteria and/or Progression of PSA by PCWG2 PSA criteria.
Measure: To estimate the antitumour activity of AZD5069 in combination with enzalutamide as measured by response rate in Phase I. Time: 24 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports