Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2022-03-01
2030-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Stratum A: Soft Tissue Sarcoma
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.
Gemcitabine
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
9-ING-41
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Docetaxel
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Stratum B: Bone Sarcoma
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.
Gemcitabine
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
9-ING-41
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Docetaxel
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
9-ING-41
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Docetaxel
Patients will receive 9.3 mg/kg 9-ING-41 twice weekly with 900 mg/m2 gemcitabine on days 1 and 8 and 75 mg/m2 docetaxel on day 8 of a 21-day cycle until disease progression or unacceptable toxicity.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stratum B: Patients must have histologically confirmed bone sarcoma that is relapsed or refractory following front-line therapy consisting of one of the following subtypes: osteosarcoma and Ewing sarcoma.
* Patients must have at least one site of measurable disease by RECIST 1.1. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
* Stratum A: No more than three prior lines of systemic therapy. Of note, anthracycline-based chemotherapy is generally considered first-line therapy. Previously untreated patients may be enrolled at the discretion of the treating investigator.
* Stratum B: At least one prior line of systemic therapy.
* Age ≥10 years.
* Lansky score ≥50 for patients \<16 years or ECOG performance status ≤2 for patients ≥16 years (Karnofsky ≥50%, see Appendix A).
* Life expectancy of greater than 12 weeks.
* Patients must have adequate organ and marrow function as defined below:
* Hemoglobin ≥8 g/dl
* absolute neutrophil count ≥1,000/mcL
* platelets ≥100,000/mcL (transfusion independent)
* total bilirubin ≤1.5x institutional upper limit of normal (ULN) (\<3.0 mg/dL and direct bilirubin \<1.5 mg/dL if documented Gilbert's syndrome)
* AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN (≤ 5 x ULN if liver metastases present)
* creatinine ≤1.5x institutional ULN OR
* glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2
* PT/INR ≤1.5x institutional ULN
* Amylase and lipase ≤1.5x institutional ULN
* Washout period prior to Cycle 1, Day 1:
* ≥ 21 days since last dose of chemotherapy, immunotherapy, or therapeutic radiation treatment.
* ≥ 28 days since last tyrosine kinase inhibitor (or 5 half-lives, whichever is shorter).
* ≥ 7 days since last focal palliative radiation treatment.
* ≥ 28 days since major surgical procedure.
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Women of child-bearing potential must have a negative serum or urine pregnancy test at registration and within 7 days of first study therapy.
* The effects of 9-ING-41 on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women may not be breastfeeding during study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of 9-ING-41 administration.
* Patients must agree to provide tumor tissue, either fresh or archival specimen of primary tumor and/or metastatic lesion. If tumor tissue is not available, then discuss with principal investigator.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Prior treatment with 9-ING-41, gemcitabine, or docetaxel.
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
* Patients who are receiving any other investigational agents for treatment of their sarcoma.
* Patients who are pregnant or lactating.
* Patients with untreated brain or meningeal metastases. Subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 14 days after definitive therapy.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 9-ING-41, gemcitabine, docetaxel, or other agents used in study.
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Has had a previous (within 2 years) or has a current malignancy other than the target cancer with the exception of curatively treated local tumors including carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade \< 6 and prostate-specific antigen within normal range.
* Has any medical and/or social condition that, in the opinion of the investigator would preclude study participation.
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Actuate Therapeutics Inc.
INDUSTRY
Brown University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bradley D DeNardo, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Galina G Lagos, MD
Role: PRINCIPAL_INVESTIGATOR
Lifespan Cancer Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hasbro Children's Hospital
Providence, Rhode Island, United States
Lifespan Cancer Insitute
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Br 398
Identifier Type: -
Identifier Source: org_study_id