Anlotinib and Irinotecan for Ewing Sarcoma

Sponsor
Peking University People's Hospital
Study ID
NCT03416517
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Ewing's Tumor Metastatic

Eligibility Criteria

Sex
ALL
Age
5 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Anlotinib — DRUG
    Anlotinib 12 or 8 mg/d po D1-14 q3w
  • Irinotecan — DRUG
    Irinotecan 20 or 15mg/m\^2/d IV over 60 minutes on days 1-5 and 8-12, q3w

Study Details

The investigators explored the activity of anlotinib combined with irinotecan in patients with relapsed and metastatic Ewing Sarcoma.

Key Dates

Start date
Jan 22, 2018
Status verified
Feb 2019
Primary completion
Feb 29, 2020
Completion
Dec 31, 2020

Study Design

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

Arms

  • Experimental: Anlotinib and Irinotecan(phase 1b)
    Anlotinib 12 or 8 mg/d PO on days 1-14 q3w. Irinotecan 20 or 15mg/m\^2/d over 60 minutes on days 1-5 and 8-12 q3w. Vincristine 1.4mg/m\^2/d IV on days 1,8 q3w. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Anlotinib and Irinotecan(phase 2)
    Anlotinib 12 or 8 mg/d PO on days 1-14 q3w. Irinotecan 20 or 15 mg/m\^2/d IV over 60 minutes on days 1-5 and 8-12 q3w. The final dose of anlotinib and irinotecan depends on the result from previous phase Ib study. Vincristine 1.4mg/m\^2/d IV on days 1,8 q3w. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) (phase 1b) [ Time Frame: 12 months ]

Central Contacts