This Phase I study is designed to assess the safety, tolerability, pharmacokinetics and anti-tumor effect of increasing doses of study drug SKI-G-801 in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are unresponsive to currently available therapies. Eligible participants will receive cycles of treatment involving IV infusion of SKI-G-801 daily for 14 days followed by 14 days off. Treatment cycles will be repeated until progressive disease or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
SKI-G-801 is administered as an IV infusion over 10 minutes
USC Norris Comprehensive Cancer Center, Clinical Investigations Support Office (CISO), 1441 Eastlake Ave., Rm. 7327
Los Angeles, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Recommended phase 2 dose (RP2D)
RP2D of SKI-G-801 determined using Neuenschwander's continual reassessment method (N-CRM)
Time frame: From Cycle 1, Day 1 until disease progression, unacceptable toxicity, patient withdrawal from study, or judged not to be in patient's interest to continue in study, assessed up to 36 months
Patients in complete remission or showing partial response (overall response rate [ORR])
Number of patients showing composite complete remission (complete remission \[CR\], complete remission with incomplete platelet recovery \[CRp\], and complete remission with incomplete hematologic recovery \[CRi\]) of SKI-G-801 according to the Response Criteria in AML
Time frame: Up to 30 days following last dose of study drug
Patients in complete remission
Number of patients showing complete remission (CR)
Time frame: Day 84 (± 3 days)
Duration of remission
Number of days between a patient's first reported status of complete remission (CR) and the earlier of disease relapse or death from any cause
Time frame: From date of first reported status of CR to the date of disease relapse or death (+ 1 day); or to date of last available disease status report for patients who do not relapse, assessed up to 36 months
Duration of event free survival
Number of days between start of treatment to date of event
Time frame: Day 1 to date of event (first documented treatment failure, relapse from CR or Cri [CR with incomplete hematologic recovery], or death due to any cause), assessed up to 36 months
Time to treatment response (TTR)
Number of days between the start of treatment to the date of first subsequent disease status of complete remission (CR)
Time frame: Day 1 to date of first subsequent disease status of CR (+ 1 day), assessed up to 36 months
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Dose limiting toxicity (DLT) Adverse Events (AEs)
Number of any DLT AEs within the first cycle of each patient's treatment with SKI-G-801
Time frame: Up to Day 28
Incidence of Adverse Events (AEs)
Number, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v4.03), seriousness and relatedness to treatment of treatment-emergent AEs
Time frame: Up to 30 days following last dose of study drug
Number of participants with clinical laboratory abnormalities
Time frame: Up to 30 days following last dose of study drug
Number of participants with overall safety profiles
Time frame: Up to 30 days following last dose of study drug
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 30 days following last dose of study drug