Cabozantinib S-Malate, Crizotinib, Savolitinib, or Sunitinib Malate in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Titre officiel

A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)

Sommaire:

Cet essai de phase II à répartition aléatoire évalue la mesure dans laquelle le (s)-malate de cabozantinib, le crizotinib, le volitinib ou le malate de sunitinib sont efficaces chez des patients atteints d’un cancer du rein qui s’est propagé dans le tissu environnant, les ganglions lymphatiques ou d’autres régions de l’organisme. Le (s)-malate de cabozantinib, le crizotinib, le volitinib et le malate de sunitinib pourraient stopper la croissance des cellules tumorales en bloquant certaines enzymes nécessaires à la croissance cellulaire.

Description de l'essai

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Response rate (RR)
  • Overall survival (OS)
  • Incidence of toxicity
PRIMARY OBJECTIVES:
I. To compare progression-free survival (PFS) in patients with metastatic papillary renal cell carcinoma (mPRCC) treated with sunitinib malate (sunitinib) to PFS in patients with mPRCC treated with MET kinase inhibitors. SECONDARY OBJECTIVES:
I. To compare Response Evaluation Criteria in Solid Tumours (RECIST) response rate (RR; defined as the combined rate of confirmed and unconfirmed partial response [PR] and complete response [CR]) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors. II. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors. III. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC. TRANSLATIONAL OBJECTIVES:
I. To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors. OUTLINE:

Patients are randomized to 1 of 4 treatment arms. As of 12/5/18, patients will only be randomized to Arm I or Arm II. ARM I: Patients receive sunitinib malate orally (PO) on days 1-28. ARM II: Patients receive cabozantinib s-malate PO on days 1-42. ARM III (CLOSED TO ACCRUAL 12/5/18): Patients receive crizotinib PO twice daily (BID) on days 1-42. ARM IV (CLOSED TO ACCRUAL 12/5/18): Patients receive savolitinib PO on days 1-42. In all arms, cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.

Voir cet essai sur ClinicalTrials.gov

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