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Clinical Trial 20179

Cancer Type: Multiple
Interventions:9-ING-41 (); Adriamycin (doxorubicin); CPT-11 (irinotecan); Camptosar (irinotecan); Gemzar (gemcitabine); Lomustine (CeeNU); Nab-paclitaxel (Abraxane); Paraplatin (carboplatin); Taxol (paclitaxel); carboplatin (); doxorubicin (); gemcitabine (); irinotecan (); paclitaxel ()

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Solmaz Sahebjam

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3beta) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors

Summary

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.

Objective

Primary: Parts 1 and 2: To evaluate the safety and tolerability, describe any dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or highest protocol-defined doses (in the absence of exceeding the MTD) and the recommended Phase 2 study dose (RP2D) for 9-ING-41 as monotherapy (Study Part 1) and in combination with chemotherapies (Study Part 2) in patients with relapsed or refractory malignancies. Part 3: To assess clinical benefit in patients with relapsed or refractory malignancies treated with 9-ING-41-based combinations at the RP2D established in Part 2. Secondary: 1. To assess pharmacokinetics and pharmacodynamics of 9-ING-41 2. To correlate response rates with specific molecular tumor profile(s) in a descriptive fashion

Inclusion Criteria

  • Aged 18 years or older and able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures.
  • Has pathologically confirmed advanced or metastatic malignancy characterized as outlined per protocol.
  • Has evaluable tumor(s) by standard radiological and/or laboratory assessments as applicable to their malignancy - in Part 3, patients with solid tumors must have least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 criteria, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI). In the case of patients with glioblastoma multiforme (GBM) or other central nervous system (CNS) tumors, the tumor must be measurable, defined as a clearly enhancing tumor with at two perpendicular diameters at entry equal or superior to 1cm.
  • Has laboratory function within parameters specified per protocol.
  • Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG) PS 0-2
  • Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug (unless in the opinion of the investigator and the study medical coordinator the treatments/ procedures will not compromise patient safety or interfere with study conduct and with IDMC agreement): (a) Chemotherapy, immunotherapy, or systemic radiation therapy - 14 days or ≥ 5 half-lives (whichever is shorter) (b) Focal radiation therapy - 7 days (c) Systemic and topical corticosteroids - 7 days (d) Surgery with general anesthesia - 7 days ( e)Surgery with local anesthesia - 3 days
  • May continue endocrine therapies (e.g. for breast or prostate cancer) and/or anti-human epidermal growth factor (Her2) therapies while on this study
  • Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 90 days after discontinuation of study treatment
  • Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 90 days after discontinuation of study treatment and use appropriate barrier contraception or true abstinence
  • Must not be receiving any other investigational medicinal product
  • For study Parts 2 and 3, must have received prior therapy for the same malignancy including the same potential partner agent(s) as that/those being considered for administration on study in combination with 9-ING-41

  • Exclusion Criteria

  • Is pregnant or lactating
  • Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation
  • Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as ≤ CTCAE) Version 4.03
  • Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of 9-ING-41, or cardiac arrhythmia requiring medical treatment detected at screening
  • Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator or study medical coordinator
  • Has known symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Patients with stable asymptomatic brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
  • Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major)
  • Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation
  • Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial
  • Has a current active malignancy other than the target cancer