Actuate 1801: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors
- Conditions
- Patients with Refractory Hematologic Malignancies or Solid TumorsRefractory Hematologic Malignancies or Solid Tumors
- Registration Number
- NL-OMON55073
- Lead Sponsor
- Actuate Therapeutics, Inc. (Actuate)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
- Is 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.
- Is aged >= 18 years
- Part 1&2: Has pathologically confirmed advanced or metastatic malignancy
characterized by one or more of the following:
a. Patient is intolerant of existing therapy(ies) known to provide clinical
benefit for their condition
b. Malignancy is refractory to existing therapy(ies) known to potentially
provide clinical benefit
c. Malignancy has relapsed after standard therapy
d. Malignancy for which there is no standard therapy that improves survival by
at least 3 months
- Part 3: Has pathologically confirmed advanced, recurrent, or metastatic
pancreatic cancer AND is previously untreated with systemic agents in the
advanced/metastatic setting.
- Has laboratory function within specified parameters (may be repeated):
a. Adequate bone marrow function: absolute neutrophil count (ANC) >= 500/mL;
hemoglobin >= 8.5 g/dL, platelets >= 50,000/mL (75,000/mL in Part 3)
b. Adequate liver function: transaminases (aspartate aminotransferase/ alanine
aminotransferase, AST/ALT) and alkaline phosphatase <= 3 (<= 10 X the upper limit
of normal (ULN) in the setting of liver metastasis or infiltration with
malignant cells) x ULN; bilirubin <= 1.5 x ULN
c. Adequate renal function: creatinine clearance >= 30 mL/min (Cockcroft and
Gault), except for carboplatin/pemetrexed arm, which should be >= 45 mL/min
d. Serum amylase and lipase <= 1.5 x ULN
- Has adequate performance status (PS): Eastern Co-operative Oncology Group
(ECOG) PS 0-3
- 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:
• Chemotherapy, immunotherapy, or systemic radiation therapy - 14 days, or >= 5
half-lives (whichever is shorter) - Part 1&2
• Focal radiation therapy - 7 days
• Systemic and topical corticosteroids - 7 days - Part 1&2
• Surgery with general anesthesia - 7 days
• 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 - Part
1&2
- May have received treatment with fluorouracil or gemcitabine as a radiation
sensitizer in the adjuvant setting if the treatment was received at least 6
months before study enrollment - Part 3
- May have received neoadjuvant chemotherapy with FOLFIRINOX if given at least
6 months before study enrollment - Part 3
- May have received prior cytotoxic doses of systemic chemotherapy in the
adjuvant setting if given at least 6 months before study enrollment - Part 3
- 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 duratio
- 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 endocrine or acinar pancreatic carcinoma - Part 3
- Has not recovered from clinically significant toxicities as a result of
prior anticancer therapy, except alopecia and infertility. Recovery is defined
as <= Grade 1 severity per Common Terminology Criteria for Adverse Events
(CTCAE) Version 4.03 (v 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 symptomatic rapidly progressive brain metastases or leptomeningeal
involvement as assessed by CT scan or MRI. Patients with stable 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 surgerymay 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
consideredmajor)
- 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
- Is considered to be a member of a vulnerable population (for example,
prisoners)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method