Clinical Trials Lab

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A crucial part of research in Medical Oncology is done via Clinical Trials, the results of which are crucial in the development of new ways of fighting cancer.

To continue moving forward in the search for the best treatment options, and get an individualised treatment for each case, it is necessary to develop a good clinical and basic-applied research.

Oncology is the field of medicine dedicated to the diagnosis and treatment of cancer. To demonstrate its effectiveness, the development of clinical research, consisting essentially of research in patient groups who voluntarily agree to participate in the study of new methods of treating cancer, is necessary. In recent decades the continuous improvement of the results in cancer treatment has mainly been due to clinical trials of new drugs. In the last 20 years there have been great advances in the knowledge of the cell biology of cancer. Today we have a better understanding of the reasons why a “normal” cell becomes a cancer cell, and what allows these cells to grow uncontrollably, avoiding the systems that usually maintain cell growth equilibrium. Based on this knowledge a new generation of drugs called “directed therapies” has been developed. Directed therapies are normally tolerated better than traditional cytotoxic drugs. We have evolved towards the concept of individualised therapies, as some of these treatments can be effective in tumours that have a molecular alteration (molecular target), but may not be effective in patients who do not have this target. It is also important not to forget the fact that hospitals with a high participation in clinical trials do better for their patients than those in which participation is lower.

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Clinical trials are research studies that are done to determine if a drug or treatment is safe and effective. Each trial attempts to answer scientific questions relating to treatment and find better ways to prevent, diagnose and treat cancer.

Clinical trials give researchers valuable information about new treatments. In some cases, they can also give the opportunity to find a cure or an improvement in the quality of life of patients who cannot be provided with standard treatments. Clinical trials may evaluate new drugs for the first time in humans (phase I), to evaluate the effectiveness of a drug in a particular type of tumour, such as breast cancer (Phase II) or test a new treatment compared to standard treatment (phase III). Clinical trials test hypotheses made by doctors and researchers to see if they can be supported by evidence. Even a clinical trial showing that a particular treatment is not effective, although it may be disappointing, is equally important in the search for new treatments.

Before a new treatment is tested in humans preclinical research in animals is conducted. The efficacy and tolerance results of new treatments in animal testing supports further investigation in humans.

The next step is research in humans:

Phase I trials: safety.

Phase I trials study how the drug is tolerated and are used to determine the highest dose that can be administered safely. Researchers can begin giving a low dose to small number of people, then one slightly higher to another group of patients, increasing the doses and so on, while patient follow-ups are conducted to monitor the occurrence of adverse effects. In general, these studies seek only to discover the maximum tolerated dose and toxicity, not treatment efficacy. Some Phase I trials evaluating new treatment combinations or new dosage regimens of drugs that have already proven to be effective.

Phase II trials: efficacy.

Phase II trials are conducted to determine if a treatment is effective. Phase II trials typically involve a relatively small number of patients that have the same type of cancer. The effectiveness of treatment is investigated, usually by measuring the rate of response to it. For most cancers, this means a reduction in tumour size. Some patients have a partial response, meaning that there is a reduction of the tumour but it has not completely disappeared. Other patients may have a complete response, meaning that there is no detectable presence of the tumour. Normally to participate in a Phase II trial, a patient must have advanced cancer and have previously received the standard treatment for this type of cancer.

Phase III trials: treatment comparison.

After completing Phase I and II, if a treatment continues to prove its effectiveness, a Phase III trial will take place in a larger group of patients. One phase III trial may be taking place in several different hospitals around the world. A phase III trial compares two or more treatments, usually one or more experimental treatments and standard treatment, to see if survival rate is greater than with the standard treatment. Some phase III trials compare the side effects of two or more treatments. In general, a Phase III involves randomisation, which means that patients are assigned to one of the treatment groups at random. Randomisation is important to guarantee the scientific validity of the research.

A treatment normally has to have shown efficacy in Phase III trials before it can be approved by the Health Authorities for wider usage. In some isolated cases where the treatment is not yet approved and the patient can not take part in a clinical trial, its use may be permitted (termed compassionate use of the drug). It is an extended form of use of the drug, which is normally limited to very specific patients, in cases where the oncologist considers it essential to achieve a good outcome.

Phase IV trials: long-term studies.

Some drugs and treatments are evaluated once they have been approved for marketing, in what are termed Phase IV trials. In these trials, researchers can track the long-term effects of treatment. Use of the drug or treatment in different populations can also be evaluated, or aspects of the quality of life.

The Clinical Trials Unit was established in 2005. It is responsible for the implementation of clinical trials in Oncology Service of the University Hospital of Santiago, with staff working on more than 100 clinical trials from Phase I to Phase IV . The team is composed of study coordinators, nurses and data entry staff. This team is responsible for logistics, coordination, data management and activities involved in the implementation of new studies.

The multidisciplinary approach of the Unit involves collaboration between medical oncologists, specialists in molecular pathology and pharmaceuticals, and clinical oncology research nurses and study coordinators, which means that the patients benefit from a wide range of expertise and knowledge in their illness, as well as detailed reports on the characteristics of their particular treatments.

Each trial has an assigned coordinator. The coordinator is responsible for the organization of procedures and evaluations required by the study protocol, acting as a link between the sponsor of the study and the research team. The coordinator also provides the promoter all necessary clinical data and monitors the quality thereof.

Clinical research nurses also have a key role in this process, since they take on a number of basic roles: identifying trends in side effects, collaborating with the multidisciplinary team to develop and evaluate patient management. They also contribute to the scientific process by ensuring quality data collection, in addition to striving for excellence in their nursing care and treatment of the participants’ symptoms.

In 2015 our unit initiated 26 new clinical trials, managing and coordinating a total of 80 patients in these trials. Additionally, we are still in the follow-up phase with many patients prior to 2015 who are still participating in their trials and receiving the study treatments.

Unit Objectives.

  • Contribute to the development of new cancer treatments.
  • Facilitate work and communication between the various professionals involved in the trial (oncologists, nurses, pharmacists, pathologists, etc.).
  • Ensure that the protocols are properly maintained from the beginning to the end of the study.
  • Guide patients participating in trials in meeting the requirements of the protocol and help them in their daily life throughout this period.
  • Consolidate our position as a referral hospital in the field of clinical oncology trials.
  • Provide high quality data, meeting deadlines.
  • Increase the number of patients enrolled in clinical trials.
  • Increase the number of clinical trials conducted.

 Unit Personnel.

  • Clinical Trials Unit Coordinator
    • Rosa López
  • Clinical Trials Coordinators
    • Cristina Blanco
    • María Iglesias
    • Carolina García
  • Clinical Trials Nurses
    • Cristina Blanco
    • Carolina García
  • Clinical Trial Assistant
    • Estiban Méndez

If you are thinking about participating in a clinical trial, you should discuss it with your doctor first to be sure you meet the conditions to do so, and your doctor deems it appropriate in your case.

The most common reasons for participating are:

- The opportunity to receive better treatment.

- More frequent patient monitoring during the study. In some clinical trials, monitoring is performed more frequently than in usual clinical practice.

- Access to drugs not readily available by other means.

- Helping others who are in the same situation.

- Contributing to the development of science.

Human trials are controlled by strict scientific and ethical principles. Before the test begins, the approval of an Ethics Committee y del Ministry of Health is required. This ensures that the test complies with existing legislation. Each clinical trial is governed by well-defined rules that constitute the trial protocol. It is mandatory for the relevant responsible parties to periodically review the clinical trial, to see that it follows procedure and does not depart from the approved rules. In addition, the clinical trial may be suspended before completion if side effects are detected more frequently than desirable.

Patients participating in a clinical trial are entitled to receive all necessary information, both verbally and in writing, before joining the trial (eg. what tests will be performed, what the possible benefits of medication being investigated are, its potential risks, how the results will be discussed, etc.) That information is contained in a document called an informed consent that patients are asked to sign freely in order to authorise their participation. Apart from the information contained in the informed consent document, patients can also consult their oncologist with further questions that arise before or during the trial. Patients also have a right to know what future use will be made of the data obtained in the trial. Finally, any participant in a clinical trial is free to leave the study at any time, both before and during the course of the study, without affecting their medical care.

Ongoing Clinical Trials


EMR 100070-005: Phase III trial, open, multi-centre avelumab (MSB0010718C) versus platinum-based doublet as first-line treatment of non-small-cell lung cancer PD-L1 + recurrent or in stage IV.

Closing date: xx/xx/xxxx

Principal Researcher: Rafael López

Clinical Trial GOAL (GECP10/03): “Study Phase Ib/IIb, randomised, multi-centre study to evaluate the efficacy and tolerability of Gefitinib combined with Olaparib (AZD2281) compared to Gefitinib alone in patients with advanced non-small-cell lung carcinoma, with mutation of the epidermal growth factor receptor (EGFR)”.

Closing date: xx/xx/xxxx

Principal Researcher: Rafael López

BI 1302.5: A multicenter, randomized, double-blind Phase III trial to evaluate efficacy and safety of BI 695502 plus chemotherapy versus Avastin plus chemotherapy in patients with advanced non-squamous Non-Small Cell Lung Cancer.

Closing date: xx/xx/xxxx

Principal Researcher: Rafael López

OLYMPIA: Trial phase III, multi-centre, randomised, double-blind, parallel group, placebo-controlled trial to evaluate the efficacy and safety of olaparib versus placebo as adjunctive therapy in patients with HER2-negative breast cancer at high risk and germ-line mutations in BRCA1/2, which have completed the local treatment and neoadjuvant or adjuvant chemotherapy.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

GO29058/SANDPIPER: “A Phase III, double-blind, placebo-controlled, randomised, more taselisib fulvestrant against more fulvestrant placebo in post-menopausal women with oestrogen receptor-positive and HER2-negative breast cancer, locally advanced or metastatic, which have submitted recurrence or progression disease during or after the treatment with an aromatase inhibitor”

Closing date: xx/xx/xxxx

Principal Researcher: xxx

SOLAR-1: Phase III trial, randomised, double-blind, placebo-controlled alpelisib in combination with fulvestrant in men and post-menopausal women with advanced breast cancer, hormone receptor-positive, HER2-negative who have progressed during or after treatment with an aromatase inhibitor.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

Parsifal 1 “Phase II study, randomised, multi-centre, open to evaluate the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative metastatic breast cancer, ER +”.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

CMCS110Z2201: Phase III study, randomised MCS110 in combination with carboplatin and gemcitabine in advanced breast triple negative (TNBC) cancer.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

CEL-CMM-2013-01: Study of quality of life in patients with metastatic breast cancer treated with second line mono chemotherapy cancer. (BioClever)

Closing date: xx/xx/xxxx

Principal Researcher: xxx

PM1183-B-003-11: A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

BO29159 – MetapHer study. A multicenter, open-label, single-arm safety study of Herceptin SC in combination with Perjeta and docetaxel in treatment of patients with HER2-positive advanced breast cancer (metastatic or locally recurrent).

Closing date: xx/xx/xxxx

Principal Researcher: xxx

PhMar-NIMES-ROC ET-D-031-14: Non-interventional, multicenter, prospective, European study to describe the effectiveness of trabectedin + PLD in the treatment of relapsed ovarian cancer (ROC) patients according to SmPC regardless of antiangiogenic drug.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

AB12008: Phase II study, prospective, multi-centre, open, active-controlled, randomised trial to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone for second-line treatment of patients with epithelial advanced ovarian cancer / metastatic refractory to first-line treatment with platinum or third-line therapy.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

GETHI 2013-01. Open phase II clinical trial of Orteronel (TAK-700) in unresectable or advanced metastatic ovarian granuloma. Greko II study.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

MODUL (MO29112): Multicentre randomised, maintenance treatment based on biomarkers for first line metastatic colorectal cancer clinical trial.

Closing date: xx/xx/xxxx

Principal Researcher: Lucía

VISNÚ-1/TTD-12-01: Clinical trial phase III, randomised, to evaluate the efficacy of bevacizumab versus FOLFOX + bevacizumab FOLFOXIRI + as first-line metastatic colorectal cancer patients previously untreated with three or more circulating tumour cells.

Closing date: xx/xx/xxxx

Principal Researcher: Cris

VISNÚ-2/TTD-12-02: Randomised Phase II clinical trial to explore the influence of the state of BRAF and PI3K, the effectiveness of FOLFIRI + bevacizumab or cetuximab as first-line treatment of patients with metastatic colorectal cancer with KRAS wild and less than three circulating tumor cells.

Closing date: xx/xx/xxxx

Principal Researcher: Cris

AB12006: A Phase III prospective, multi-centre, randomised, double-blind, placebo-controlled, 2-parallel groups to compare the efficacy and safety of masitinib in combination with FOLFIRI (irinotecan, 5-fluorouracil and folic acid) versus placebo in combination with FOLFIRI in the second-line treatment of patients with metastatic colorectal cancer.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

IMPALA study: Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment. MGN1703-C06.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

CECILIA (MO29594) Phase II study, open, multi-centre single-arm to evaluate the safety and efficacy of bevacizumab in combination with carboplatin and paclitaxel in patients with metastatic, recurrent or persistent cervical cancer.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

POLO-1: “Phase III study, randomised, double-blind, placebo-controlled, multi-centre study of monotherapy maintenance olaparib in patients with metastatic pancreatic cancer mutation gBRCA whose disease has not progressed with first-line chemotherapy based on platinum”

Closing date: xx/xx/xxxx

Principal Researcher: xxx

CEL-SCI: A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only.

Closing date: xx/xx/xxxx

Principal Researcher: Cris

CA209-498: Study Phase 3 randomised, open, nivolumab versus temozolomide, each in combination with radiation therapy, in adult subjects with newly diagnosed glioblastoma with unmethylated MGMT (O-6-methylguanine DNA methyltransferase tumour)

Closing date: xx/xx/xxxx

Principal Researcher: xxx

CA209-548: Phase 2, randomised, single-blind, temozolomide plus radiotherapy combined with nivolumab or placebo in adult subjects with newly diagnosed glioblastoma with MGMT (06-methylguanine DNA methyltransferase tumor) metiladoCA209-548: Phase 2, randomised, simple blind, temozolomide plus radiotherapy combined with nivolumab or placebo in adult subjects with newly diagnosed glioblastoma with methylated MGMT (06-methylguanine DNA methyltransferase tumor).

Closing date: xx/xx/xxxx

Principal Researcher: xxx

GIST – AB04030: Prospective study, multi-centre, randomised, open, controlled active drug, parallel group, phase III study to compare the efficacy and safety of masitinib at 7.5 mg / kg / day imatinib 400 or 600 mg in the treatment of patients with gastrointestinal stromal tumour as first-line medical treatment.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

GEIS 27: A phase I / II multi-centre prospective nilotinib and adriamycin as neoadjuvant treatment in retroperitoneal liposarcoma and leiomyosarcomas.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

D419BC00001(DANUBE): Phase III Trial, randomised, open, controlled, multi-centre, international, MEDI4736 MEDI4736 monotherapy and in combination with tremelimumab versus standard treatment with first-line chemotherapy in patients with unresectable stage IV bladder urothelial cancer.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

GEM-1202 GRAY-B: Clinical trial phase II, multi-centre, with one group on the combination of radiotherapy and ipilimumab for the treatment of patients with melanoma and brain metastases.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

GEM-1402: Open clinical trial, multi-centre, nonrandomised phase II to evaluate the effectiveness of Nivolumab in combination with ipilimumab in patients with previously untreated metastatic uveal melanoma.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

SOG-ANG-2013: A prospective multi-centre observational study to identify biomarkers with prognostic and predictive value of response to antiangiogenic drugs approved in the first-line treatment of metastatic/ locally advanced renal cell.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

BASKET (PM1183-B-005-14): A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

CINC280A2103: A phase I, multicenter, open-label, single-sequence drug-drug interaction study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors.

Closing date: xx/xx/xxxx

Principal Researcher: xxx

Team


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