Solid Tumors Clinical Trial
Official title:
Protocol to Obtain Tumor Biopsies From Patients With Locally Advanced (Incurable) or Metastatic Cancer to Improve Selection for Clinical Trials. (CPCT - 05 Biopsy Protocol Patient Selection)
Our knowledge on the genetic mutations in cancer is rapidly expanding and we are increasingly
testing drugs in mainly metastatic cancer patient populations with rare mutations. Successful
examples of this new strategy are ALK inhibitors in ALK translocated NSCLC (less than 5%
frequency) and EGFR inhibitors in EGFR mutant NSCLC (approximately 5% frequency). Selecting
molecularly stratified patient populations for studies benefits the patient as it increases
the odds of obtaining benefit from experimental treatment, especially in early clinical
trials. Moreover it increases the speed and efficacy of drug development as signs of efficacy
are picked up in earlier phases. Therefore, broad screening of molecular lesions in the
tumors of patients that are being considered for participation in trials is crucial. This
pre-selection increases our ability to perform several trials in parallel and thus include
more patients in more meaningful trials. With the still dismal prognosis of patients with
metastatic cancer, increasing the accrual rate to pivotal trials in selected patient
populations is a key factor in improving prognosis.
The advent of Next Generation Sequencing (NGS) platforms enables us to probe a limited number
of cancer related genes within 2-4 weeks. We have extensively piloted this approach and are
now able to deliver clinically meaningful turn-around-times. This development enables us to
use this technology to enrich clinical trials using targeted therapies for patients with
specific mutations.
We will obtain tumor biopsies of a metastatic or locally advanced lesion and a peripheral
blood sample from all patients included in the trial; the biopsies to obtain information on
the tumor related genetic mutations (mutational profile) and the blood samples to assess each
patient's germline DNA background variation. As patients will be asked to undergo an invasive
procedure it is important to address the potential safety issues. Review of the literature
and our own experience show that tumor biopsies can be performed with only minor
complications and acceptable risks. We will recruit patients with metastatic or locally
advanced solid tumors from patients that can potentially be included in clinical trials.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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|
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