PLATFORM Study of Precision Medicine for Rare Tumors

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT04423185
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Rare Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Almonertinib 110 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying EGFR mutations will be administrated with Almonertinib.
  • Dacomitinib 45 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying EGFR mutations will be administrated with Dacomitinib.
  • Alectinib 150 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying ALK fusion will be administrated with Alectinib.
  • Crizotinib 250 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation will be administrated with Crizotinib.
  • Pyrotinib 160/80 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying HER-2 mutation or HER-2 over expression/amplification will be administrated with Pyrotinib.
  • Imatinib 400 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying CKIT mutation will be administrated with Imatinib.
  • Niraparib 200/300 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying BRCA1/2 mutation will be administrated with Olaparib.
  • Palbociclib 125mg — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying CDKN2A mutation will be administrated with palbociclib.
  • Vemurafenib 240 MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying BRAF mutation will be administrated with Vemurafenib.
  • Sintilimab 100MG — DRUG
    Patients with advanced rare tumors who failed to standardized treatment carrying no targeted alterations will be administrated with Sintilimab.
  • Atezolizumab 1680 MG — DRUG
    Patients with BRAF mutation treated with vemurafenib, after acquired resistance, will combine vemurafenib with atezolizumab.

Study Details

A Phase II, open label, non-randomized, multiple-arm, single-center clinical trial in patients with advanced rare solid tumors who failed to standard treatment.

Key Dates

Start date
Aug 15, 2020
Status verified
Feb 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2028

Study Design

Enrollment
770 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Almonertinib-EGFR mutation
    Administration: 110 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Dacomitinib-EGFR mutation
    Administration: 45 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Alectinib-ALK fusion
    Administration: 600 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Crizotinib-ALK fusion
    Administration: 250 mg oral bid, to disease progression or intolerable adverse effects.
  • Experimental: Vemurafenib-BRAF mutation
    Administration: 960 mg oral bid, to disease progression or intolerable adverse effects.
  • Experimental: Niraparib-BRCA mutation or HRD
    Administration: 200/300 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Pyrotinib-HER-2 overexpression/amplification
    Administration: 400 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Imatinib-CKIT mutation
    Administration: 400 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Palbociclib-CDKN2A mutation
    Administration: 125 mg oral qd for 21 days q28d, to disease progression or intolerable adverse effects.
  • Experimental: Crizotinib-ROS-1 fusion
    Administration: 250 mg oral bid, to disease progression or intolerable adverse effects.
  • Experimental: Crizotinib-C-MET amplification
    Administration: 250 mg oral bid, to disease progression or intolerable adverse effects.
  • Experimental: Crizotinib-C-MET mutation
    Administration: 250 mg oral bid, to disease progression or intolerable adverse effects.
  • Experimental: Pyrotinib-HER-2 mutation
    Administration: 400 mg oral qd, to disease progression or intolerable adverse effects.
  • Experimental: Sintilimab-PD-1
    Administration: 200mg q21d, to disease progression or intolerable adverse effects.
  • Experimental: Combination ARM-Niraparib & Sintilimab
    Niraparib (200mg oral qd) combined with Sintilimab (200mg iv q21d) after acquired resistance to Niraparib.
  • Experimental: Combination ARM-Vemurafenib & Atezolizumab
    Vemurafenib (960 mg oral bid) \& Atezolizumab (1200mg iv q21d) after acquired resistance to Vemurafenib.
  • Experimental: Combination ARM-Palbociclib & Atezolizumab
    Palbociclib (125 mg oral qd for 21 days q28d) combined with Atezolizumab (1680mg iv q28d) after acquired resistance to Palbociclib.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Measured from first dose until confirmed response or progression, assessed up to 2 years. ]

Central Contacts