Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: SHIVA02 - Evaluation of the Efficacy of Targeted Therapy Based on Tumor Molecular Profiling in Patients With Advanced Cancer Using Each Patient as Its Own Control (SHIVA02)

Summary: The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling versus conventional chemotherapy in patients with advanced cancer using each patient as its own control. This study is a study involving patients with advanced cancer. All types of solid tumors will be allowed in the study.


Eligibility: Inclusion criteria:
  Inclusion will proceed in 2 steps. First step for molecular analyses and second step in order to be included in the efficacy analysis.
  Inclusion criteria for Step 1:
  1. Patient with recurrent/metastatic solid tumor who failed or are not candidate for treatments usually proposed in first intention and for whom a prospective clinical trial has been indicated in a tumor board
  2. Patient with a documented progression before the start of conventional therapy according to RECIST 1.1.
  3. Patient ≥18 years old
  3) Disease amenable to biopsy 5) ECOG performance status of 0 or 1 6) Measurable disease 7) Adequate renal function defined by a serum creatinine <1.5xUNL (upper normal limit) 8) Adequate liver function test defined by SGOT & SGPT <3xUNL (5xUNL in case of liver metastases), and bilirubin level <1.5xUNL 9) Adequate bone marrow function defined by platelets >100,000/mm3, hemoglobin >9 g/dL, and neutrophils >1,000/mm3 10) Patient must be affiliated to the French Social Security System 11) Signed informed consent 12 For female of child-bearing potential: a negative pregnancy test <72 hours before starting study treatment is required. If sexually active, female of childbearing potential must use "highly effective" methods of contraception for the study duration and for 3 months following the last treatment 13) For male of reproductive potential: any sexually active male patient must use a condom while on study treatment and for 3 months following the last treatment
  Inclusion criteria for Step 2:
  1. Patient for whom the Molecular Biology Board (MBB) has identified a druggable molecular alteration of the RAF/MEK signaling pathway and a treatment recommendation has been established by the MBB.
  2. Patient with a documented progression during the conventional therapy according to RECIST 1.1.
  3. Patient with imaging performed within 28 days prior to the planned start date of treatment
  Exclusion criteria:
  1. Patients below 18 years old
  2. Patients with CNS involvement that has not been controlled for >3 months
  3. Patients planned to receive a molecularly targeted agent
  4. Patients who are candidate to receive a molecularly targeted agent that is approved for their disease
  5. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infection within one year, chronic liver or renal disease, active gastrointestinal tract ulceration, severely impaired lung function
  6. Pregnant and/or breastfeeding women
  7. Patients individually deprived of liberty or placed under the authority of a tutor
  8. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  9. Known HIV, HBV, or HCV infection

Relevance to patient case: not relevant