A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
Status:
Withdrawn
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
Summary
9-ING-41 in combination with gemcitabine and docetaxel will lead to sustained disease control
and/or increase the rates of objective response in patients with unresectable or metastatic
soft tissue and bone sarcomas.
This is an open label, two-stratum, phase 2 clinical trial evaluating the efficacy of
9-ING-41 in combination with gemcitabine/docetaxel in patients ≥10 years of age with advanced
sarcoma.
Stratum A: Patients with advanced soft tissue sarcoma previously treated with 0-3 prior lines
of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1 and 8 and
docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Stratum B: Patients with relapsed or refractory bone sarcoma previously treated with at least
one line of systemic therapy will receive 9-ING-41 twice weekly with gemcitabine on days 1
and 8 and docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable
toxicity.
Disease response assessment will be performed every 2 cycles (6 weeks) for the first 8 cycles
(24 weeks), then every 12 weeks thereafter.