A clinical trial of a new drug known as 9-ING-41, that will take place inpatients with tumors or cancers that affect the blood and lymph system.9-ING-41 will be assessed as a standalone drug as well as being assessedwhen taken with chemotherapy drugs

Phase 1

Conditions: Refractory Hematologic Malignancies or Solid Tumors
MedDRA version: 21.1Level: PTClassification code 10066476Term: Haematological malignancySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-003739-32-PT

Lead Sponsor: Actuate Therapeutics Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 512

Inclusion Criteria

Only Part 3B criteria are listed:

1. 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
2. Is aged = 18 years
3. Has pathologically or cytologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting AND would be a candidate to receive gemcitabine/nab-paclitaxel as a first-line treatment
4. Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)
5. Has laboratory function within specified parameters (may be repeated):
a.Adequate bone marrow function: absolute neutrophil count (ANC) = 1500/mL; hemoglobin = 8.5 g/dL, platelets = 100,000/mL
b.Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase = 5 x the upper limit of normal (ULN); bilirubin = 1.5 x ULN
c. Adequate renal function: serum creatinine = ULN OR creatinine clearance = 60 mL/min for patients with a serum creatinine >ULN (calculated by the Cockcroft and Gault formula)
6. Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1
7. Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug:
• Focal radiation therapy – 7 days
• Surgery with general anesthesia – 7 days
• Surgery with local anesthesia – 3 days
8. 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
9. 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 6 months after discontinuation of study treatment
10. Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 3 months after discontinuation of study treatment and use appropriate barrier contraception or true abstinence
11. Must not be receiving any other investigational medicinal product
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 341
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 171

Exclusion Criteria

Only Part 3B criteria are listed:

1. Is pregnant or lactating
2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation
3. Has endocrine or acinar pancreatic carcinoma
4. Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and/or infertility. Recovery is defined as = Grade 2 severity per CTCAE, v5.0
5. 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 study therapy, or uncontrolled cardiac arrhythmia
6. Has had a myocardial infarction within 12 weeks of the first dose of study therapy or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator
7. 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
8. 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)
9. Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation.
10. 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.
11. Has a current active malignancy other than pancreatic cancer
12. Is considered to be a member of a vulnerable population (for example, prisoners).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Only part 3B objective is listed:<br><br>• To determine the 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in stage of the study compared to the control arm.;Secondary Objective: Only part 3B objectives are listed:<br><br>• To determine the rate of disease control of the combination of 9-ING-41 and gemcitabine/nab-paclitaxel (GA) in patients with pancreatic cancer without prior systemic therapy for advanced disease.<br>• To correlate disease control rate with tumor molecular profiles.<br>;Primary end point(s): Only part 3B endpoint is listed:<br><br>• 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in portion of the study compared to the control arm.;Timepoint(s) of evaluation of this end point: 1 year from the first dose of protocol anticancer medications

Secondary Outcome Measures

Name	Time	Method

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