Compliant and Professional

Study Execution

Studies

 

Phaon conceptualizes and executes studies based on the following three-step model:

 

The first step involves the development of a concept including the general feasibility analysis, including the statistical and operational feasibility. Once such concept feasibility is finalized, it will be set up with cooperation partners, which includes budget and timelines for set out scope. Such is done through a thorough proposal involving scenario analysis for the trial resulting in realistic budget estimations.
As soon as the financing of the study is settled, the palleos operational team will start with the study set up and full execution of the study. In the end, Phaon will work on the final publication and guarantee scientific dissemination of results.

TitleStatusPhase

BREVITY – Breast Cancer Response Evaluation for Individualized TherapyClosedIn vitro Diagnostic Validation Trial

CountriesCanada, US, Germany, Italy, Ireland
IndicationEarly Breast Cancer
InterventionIn vitro Diagnostic Study
# of sites40
# of patients722
Linkhttp://rnadiagnostics.com/brevity/

Rna Diagnostics has initiated an international prospective clinical trial to validate the RNA Disruption Assay™ (RDA™) as a tool for management of primary breast cancer treatment. The goal of the international trial is to define and validate the test's predictive capabilities regarding pathological Complete Response (pCR) at surgery in patients with breast cancer treated with neoadjuvant chemotherapy. One of Phaon's goals is to support translational research fostering the pathway to individualized medicine. We supported this trial from a scientific perspective with Prof. Dr. Kolberg- Liedtke as lead international investigator and PD Dr. Kolberg as head of the protocol board, thereby providing scientific advice from a clinical perspective.

NeoMono - An adaptive randomized neoadjuvant two arm trial in triple-negative breast cancer comparing a mono Atezolizumab window followed by a Atezolizumab - CTX therapy with Atezolizumab – CTX therapySet-UpPhase II

CountriesGermany
IndicationPrimary, treatment naïve triple negative early breast cancer
InterventionDrug Intervention
# of sites40
# of patients458
LinkAbout us

The NeoMono is a Phaon-Initiated Phase 2 trial, which uses an adaptive bayesian trial design to compare efficacy of neoadjuvant chemotherapy with PDL1-inhibition (Atezolizumab) and Atezolizumab two-week window to chemotherapy with PDL1-inhibition (Atezolizumab). It's translational objective lies in identifying biomarkers predicting (early) response to or resistance against Atezolizumab (alone and with CTX) allowing patients stratification in future clinical trials.