9-ING-41 in Patients With Advanced Cancers
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Actuate Therapeutics Inc.
- Study ID
- NCT03678883
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Acute T Cell Leukemia Lymphoma
- Bone Cancer
- Bone Metastases
- Bone Neoplasm
- Breast Neoplasms
- Cancer
- Malignancies
- Malignancies Multiple
- Malignant Glioma
- Neoplasm Metastasis
- Neoplasm of Bone
- Neoplasm of Lung
- Neoplasm, Breast
- Neoplasms Pancreatic
- Neoplasms,Colorectal
- Pancreas Cancer
- Pancreatic Adenocarcinoma
- Pancreatic Cancer
- Pancreatic Neoplasms
- Refractory Cancer
- Refractory Neoplasm
- Refractory Non-Hodgkin Lymphoma
- Renal Cancer
- Resistant Cancer
- Sarcoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 9-ING-41 — DRUGStarting dose of-9-ING-41 will be administered on Day 1 and 4 each week of a 21-day cycle. 9-ING-41 will be administered intravenously over 60 minutes.
- Gemcitabine - 21 day cycle — DRUGGemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle
- Doxorubicin. — DRUGDoxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2.
- Lomustine — DRUGLomustine 30 mg/m² orally as a single dose, weekly for twelve weeks.
- Carboplatin. — DRUGCarboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle.
- Nab paclitaxel. — DRUGNab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle
- Paclitaxel. — DRUGPaclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle.
- Gemcitabine - 28 day cycle — DRUGGemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle
- Irinotecan — DRUGIrinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle
Study Details
GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.
Key Dates
- Start date
- Jan 4, 2019
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 350 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 9-ING-41Drug: 9-ING-41
- Experimental: 9-ING-41 plus GemcitabineDrugs: Gemcitabine - 21 day cycle. 9-ING-41
- Experimental: 9-ING-41 plus DoxorubicinDrugs: Doxorubicin. 9-ING-41
- Experimental: 9-ING-41 plus LomustineDrugs: Lomustine. 9-ING-41.
- Experimental: 9-ING-41 plus CarboplatinDrugs: Carboplatin. 9-ING-41.
- Experimental: 9-ING-41 plus nab paclitaxel GemcitabineDrugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.
- Experimental: 9-ING-41 plus Paclitaxel/CarboplatinDrugs: Paclitaxel. Carboplatin. 9-ING-41.
- Experimental: 9-ING-41 plus IrinotecanDrugs: Irinotecan. 9-ING-41.
Primary Outcome Measure
Parts 1/2: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 3 months to 3 years ]
Locations (40)
Find similar trials in Phoenix, AZ
By condition
Related Studies
- Specimen and Data Study for Ovarian Cancer Early Detection and PreventionRecruiting · Northwestern University · Chicago, Illinois
- Effects of Oncological Treatment During Pregnancy on Mother and ChildRecruiting · University Hospital, Gasthuisberg · Camden, New Jersey
- Novel Biochemical and Molecular Determinants for Soft Tissue SarcomaRecruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
- Ascertainment of Families for Genetic Studies of Familial Lymphoproliferative DisordersRecruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey