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A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas

NCT04906876 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-07-28

No results posted yet for this study

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.

Conditions

  • Sarcoma
  • Soft Tissue Sarcoma
  • Metastatic Sarcoma
  • Undifferentiated Pleomorphic Sarcoma
  • Myxofibrosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Angiosarcoma
  • Synovial Sarcoma
  • Rhabdomyosarcoma
  • Spindle Cell Sarcoma
  • High Grade Sarcoma
  • Bone Sarcoma

Interventions

DRUG

Gemcitabine

Gemcitabine as a 90-minute IV infusion

DRUG

Docetaxel

Docetaxel as a 60-minute IV infusion

DRUG

9-ING-41

9-ING-41 as an IV infusion over 1-4 hours twice weekly

Sponsors & Collaborators

  • Actuate Therapeutics Inc.

    collaborator INDUSTRY

  • Brown University

    lead OTHER

Principal Investigators

  • Bradley DeNardo, MD · Brown University

  • Don S Dizon, MD · Lifespan Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04906876 on ClinicalTrials.gov