Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion
Joshua Sasine(ucla)

Description

Summary

This study will determine the safety and maximum tolerated dose of ONO-7475 in patients with relapsed or refractory acute leukemia and evaluate the efficacy of ONO-7475 in patients with newly diagnosed AML

Official Title

A Phase I Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Efficacy of ONO-7475 in Patients With Acute Leukemias

Keywords

Acute Leukemia Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MER MERTK TYRO3 AXL AML de novo AML Relapsed/ Refractory AML TAM Acute Disease ONO-7475 ONO-7475: dose escalation

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients aged ≥18 years at time of screening
  2. Written informed consent by the patient (or legal representative) prior to admission to this study. In addition any locally required authorization (Health Insurance Portability and Accountability Act in the USA [HIPAA], obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  3. Adequate renal and hepatic function defined as:
  4. Total bilirubin within 1.5 x ULN, except those with Gilberts syndrome for whom this must be <3 x ULN
  5. AST(SGOT) and ALT(SGPT) <2.5 x ULN
  6. Calculated Creatinine clearance>/= 45ml/min
  7. Serum Albumin >2.5g/dL For any patient laboratory values outside the ranges outlined above that are considered due to the patient's underlying disease (AML or ALL), the patient may be enrolled into the study following consultation between the Investigator and the Sponsor's Medical Officer if the patient is likely to benefit from receiving ONO-7475 (based on the Investigator's assessment)
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 as assessed during the screening period and then again anytime during the 2-day period immediately preceding the start of ONO-7475 dosing.
  9. Life expectancy of at least 3 months
  10. Sexually active female patients of childbearing potential and sexually active male patients must agree to use an effective method of birth control (e.g., barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 4 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records and be defined as any of the following: surgical hysterectomy with bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with last menses >1 year ago.
  11. Male patients must use a condom from the time of the first administration of ONO-7475 until 4 months following administration of the last dose.
  12. Diagnosis of AML according to WHO criteria 2016.
  13. Relapsed or refractory AML patients with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, not likely to benefit from standard salvage chemotherapy.
  14. . All patients must have received at least one prior therapy - 1 cycle of cytarabine containing regimen or 2 cycles of hypomethylating agent - before determination of refractory status (defined as response duration less than 3 months or no response)

You CAN'T join if...

  1. Patients with active Central Nervous System (CNSL) Leukemia
  2. QTcF prolongation defined as a QTcF interval >470 msec or other significant ECG abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min).
  3. Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or severe cirrhosis
  4. HIV/active Hepatitis B or C infection
  5. Retinal disease (e.g. retinitis pigmentosa including Mertk mutations), retinal hemorrhage or any disorder which may inhibit follow up for retinal toxicity
  6. Serious intercurrent medical or psychiatric illness that will prevent participation or compliance with study procedures, including serious active infection
  7. Acute promyelocytic leukemia (FAB M3 classification)
  8. Patients not recovered to Grade 1 or stabilized from the effects (excluding alopecia) of any prior therapy for their malignancies
  9. Concurrent treatment with other investigational drugs.
  10. . Daily requirement for corticosteroids ≥ prednisone 10 mg/day or equivalent.
  11. . Prior hematopoietic stem cell transplantation within 12 weeks of the first dose of study treatment or ongoing immunosuppressive therapy for graft versus host disease
  12. . Participation in another clinical trial with any investigational drug within 14 days or with any licensed drug within five half-lives, prior to the first ONO-7475 dosing.
  13. . Prior AML or ALL therapy (non-experimental) within 14 days or five half-lives whichever is longer, prior to the first dose of ONO-7475 (except those permitted in the protocol) and no residual toxicity from the prior therapy hindering of the ONO-7475 dosing.
  14. . Prior radiotherapy within 21 days of screening. Localized radiation therapy within the last 7 days is acceptable. Concurrent radiotherapy is not permitted.
  15. . Patients undergoing current treatments for other cancers
  16. . Pregnant or lactating women
  17. . Proliferative disease (WBC > 30 x 109 /L) confirmed prior to first dose of ONO-7475
  18. . Active malignancy, other than AML (Parts A and B) or ALL (Part C), requiring systemic therapy

Locations

  • University of California accepting new patients
    Los Angeles California 90095 United States
  • University of Southern California not yet accepting patients
    Los Angeles California 90033 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ono Pharmaceutical Co. Ltd
ID
NCT03176277
Phase
Phase 1
Study Type
Interventional
Last Updated