A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT04337879
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

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

Interventions

  • AL2846 — DRUG
    AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.
  • Calcium folate — DRUG
    Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle
  • 5-FU — DRUG
    5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.
  • Oxaliplatin — DRUG
    Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle.
  • Irinotecan — DRUG
    Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle.

Study Details

This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.

Key Dates

Start date
Jul 20, 2020
Status verified
Jan 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AL2846 + mFOLFOX6
    AL2846 capsule administered orally,once daily in 28-day cycle; oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle；calcium folate 400mg/ ㎡ IV on day 1, day 15 in 28-day cycle；5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 in 28-day cycle.
  • Experimental: AL2846 + FOLFIRI
    AL2846 capsule administered orally,once daily in 28-day cycle; irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle; calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle; 5-fu 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: up to 12 month ]

Central Contacts

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