Author Archive

The AZENT Study

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We are pleased to announce that the AZENT study “A phase IIa clinical trial to evaluate the safety and efficacy of osimertinib (AZD9291) in first-line patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer and concomitant EGFR T790M mutation at time of diagnosis (AZENT study)” has achieved 100% of recruitment!!

7 Spanish sites are participating in this study and the number of patients included is 22. Recruitment started in July 2016 and there are currently 50 patients have been recruited (22 patients included and 28 screening failure). Thanks to the study team because there was a high rate of screening failures (28 Screening failures) and it was a big challenge.

From MedSIR, we would like to thank all the study teams for their implication and effort identifying patients that can benefit from their participation. Especially to Dr. Majem at Hospital Sant Pau and Dr. Viteri at Hospital Dexeus, they are the top recruiters in the study.

Thanks to the commitment of all the sites involved in AZENT study, and the constant support from Astrazeneca, we are making effort for open the second stage after the evaluation of the results obtained during the interim analysis, this interim analysis will assess the primary endpoint to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis. Recruitment of patients will resume until a total of 73 patients opening national and international sites.

MedSIR INSIDE OUT – Christian Gonzalez

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Today we are happy to interview our new Business Development guy, Christian Gonzalez.

MedSIR Newsletter Team (MS): Thanks, Christian, for spending some time with us here today.

Christian Gonzalez (CG): Thank you, the pleasure is all mine!

MS: What brought you to MedSIR? How did you discover us?

CG: I learned about MedSIR through LinkedIn… I noticed right away that MedSIR has a very strong online presence… Indeed, MedSIR is constantly updating their followers on social media with the latest in-house developments and news. I then met Maria Campos, our strategy director, who introduced me to François Riva the director of business development. François got me hooked! It has been a great pleasure being part of his team!

Tell us Christian, where were you before? Were you working in the same sector?

CG: I was working in Amsterdam… at a wonderful office at a very large neuroscience research institute and hospital… Over there I was involved in project development, partnering, clinical trials, and also preclinical projects in neuroscience… prior to that I was working in consulting… and for many years, in a previous life, I worked in cancer research at several research centers and hospitals in both the US and Europe. MedSIR is by far one of the most exciting places where I´ve worked… good science and very enthusiastic colleagues!

MS:I understand then that you are used to traveling a lot. In how many countries have you lived in? Where would you stay?

CG: I have lived in seven countries. I´ve spent the most time in the United States… in New York City and Cambridge. Those two cities are very special to me… New York being a cosmopolitan and interesting place to be at and Cambridge being an international biotech hub… With that said, I wouldn´t trade Barcelona for either of them. Barcelona is a beautiful city with wonderful people… and importantly, it is a prominent center for research and development… specially in oncology. There is a number of world-renowned hospitals and research centers in this area… indeed, it´s a great place to be if you work in oncology! I stay in Barcelona!

MS: As you already know, this year we jump to US with a new office there. We think that this is an important step for MedSIR. Could you tell us your opinion about this?

CG: I think having a foot in America is a critical strategic move for MedSIR… it is also a very exciting project. For sure our clients will be very interested in seeing how that office develops… so stay tuned!

MS: And if we have to talk about the company…. What’s your opinion about the way we work at MedSIR? (#medsirstyle)

CG: It´s great being at MedSIR… The first thing I noticed when I started at MedSIR was how passionate and dedicated everyone is… to their project, to cancer research in general. You see the Trial Managers and the Site Managers giving their all to ensure the successful execution of projects… There is also a lot of flexibility in how we work and I think that this is a key element that contributes to our success. I am part of the Business Development Department… it is a small and tightly knit team spearheaded by François Riva as I mentioned earlier… We are tasked with identifying and developing new ideas together with our collaborators… it´s a process in which we all contribute… it truly is teamwork. This is something that I really value. We are constantly updating each other and discussing project progress or any challenges. François has fostered a great collaborative working culture within our team making it a great place to be!

MS: Tell us more about you… What do you do in your free time to free your mind from MedSIR?

CG: Well I moved to Barcelona fairly recently… and it is summer… so I enjoy getting out town on weekends and exploring Catalonia. I´ve recently taken Olympic weightlifting too… let´s see how that goes!

MS: Thanks so much Christian for your time!

CG: Thank you again!

The Kelly Study

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We are happy to inform you that we have achieved the 75% of recruitment of the KELLY study!

This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients with hormone receptor-(HR) positive/HER2-negative metastatic breast cancer (MBC) previously treated with at least one, but not more than two, prior chemotherapeutic regimens for treatment of locally recurrent and/or metastatic disease. Prior therapy must have included an anthracycline and a taxane, and prior anti-hormonal therapy in the metastatic disease setting is mandatory.

11 Spanish sites are participating in this study and the number of patients to be included is 44. Recruitment started in February 2018 and there are currently 33 patients included (23 patients are ongoing now) and 3 patients in screening. 

This study also includes the sub-study CALADRIO (approved in May 2018), with the interest to characterize the microbiome as a potential predictive factor of response to anti-PD-1 immunotherapy pembrolizumab in patients with the KELLY indication. Since May 2018, buccal and fecal microbiome samples have been collected for 18 patients.

From the MedSIR team, we would like to thank all the study teams for their implication and effort identifying patients that can benefit from their participation. In special, we would like to thank for their commitment and for being the top recruiters to Hospital Clínico de Valencia (Dr Begoña Bermejo), Hospital Ramón y Cajal (Dr María Gion), Hospital Quironsalud de Barcelona (Dr José Pérez) and MD Anderson (Dr Raúl Márquez). Another special thanks is for MSD and Eisai for their continuous support. We are confident to reach the end of recruitment in October 2018, as initially planned.

The BioPER study

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The BioPER study “A Multicentre, International, Non-controlled Phase II Trial to Identify the Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge Upon Progression to a Palbociclib Combination in ER-positive Metastatic Breast Cancer Patients (BioPER)” reached its equator last 20th July 2018.

This is a proof of concept, international, open-label, non-controlled, multicenter phase II trial with two different primary objectives: a biological and a clinical objective. From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advanced breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression. From a biological point of view, the challenge is to define a molecular profile that allows identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen. One of the main hurdles in recruitment is the need to obtain a biopsy at the time of progression to the previous palbociclib line to be eligible, making the screening and selection of participants a very stringent process.

From MedSIR, we would like to thank all the study teams for their continuous effort identifying putative patients. At the moment, IEO (Dr. Curigliano) in Italy and Hospital Duran i Reinals (Dr. Gil) and Hospital del Mar (Dr. Albanell) in Spain are the top recruiters of the study. Thanks to the commitment of all the Sites involved in BioPER, and the constant support from Pfizer, we are confident to reach the end of recruitment in December 2018.

The PHERGain Study

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We are pleased to announce that PHERGain study “Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy” has achieved 40% of recruitment!!

The study assesses the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for a pathologic complete response (pCR) in the breast and axilla.

58 sites are planned to participate in the study and a total of 295 patients have been recruited (160 patients randomized and 116 screening failure) since June 2017. It’s a very interesting study that involves collaboration from Oncology, Radiology and Pathological Anatomy services. Thank you very much to all of them and specially to Hospital Virgen del Rocío (Dr Manuel Ruiz Borrego), Hospital Clínic Universitari de Valencia (Dr Begoña Bermejo), Hospital Vall Hebrón (Dr Santiago Escribà), Hospital Ramón y Cajal (Dra Noelia Martinez) and ICO L’Hospitalet (Dra Agostina Stradella) as top recruiters. The research team was supported by an unrestricted fellowship from Roche.

We will continue working on study recruitment and we count with your collaboration to finalize patient inclusion in December 2018 with 400 patients enrolled.