Description:
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.
Title
- Brief Title: Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)
- Official Title: A Phase 1 Dose Escalation Trial of SKI-G-801 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Clinical Trial IDs
- ORG STUDY ID:
OSCO-P1301
- NCT ID:
NCT03564288
Conditions
Interventions
Drug | Synonyms | Arms |
---|
SKI-G-801 | | Dose Escalation Cohort |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation Cohort | Experimental | To identify the recommended phase 2 dose (RP2D) of SKI-G-801 in patients with relapsed or refractory AML (Acute Myeloid Leukemia) | |
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide written informed consent for participation, prior to
completing any study-related procedures.
- Diagnosis of Acute Myeloid Leukemia (AML)
- Patients must have been off previous antileukemia therapy for at least 2 weeks or 5
half-lives, whichever is longer if the immediate prior regimen included only weekly
chemotherapy; or 4 weeks or 5 half-lives, whichever is longer, from any therapy with
therapeutic biologics and from any type of investigational therapy. Daily hydroxyurea
for up to 2 weeks to keep the absolute blast count below 50 x 10⁹/L will be allowed,
but must be discontinued 24 hours prior to administration of study drug. Hydroxyurea
will be permitted during the first cycle of treatment if necessary.
- At least one prior induction regimen (with or without consolidation) which may have
included hematopoietic stem cell transplantation (HSCT).
- Have adequate liver function.
- Have adequate renal (kidney) function.
- Female patients must either be of non-childbearing potential, or, if of childbearing
potential, have a negative urine pregnancy test at screening and agree not to try to
become pregnant during the study and for 45 days after the final study drug
administration. Women of childbearing potential, if heterosexually active, must agree
to use 2 forms of highly effective birth control as determined by the protocol,
starting at screening, throughout the study period and for 45 days after the final
study drug administration.
- Female patients must agree not to breastfeed at screening, throughout the study period
and for 45 days after the final study drug administration.
- Male patients with female spouse/partner of childbearing potential, must agree to use
2 forms of highly effective birth control as determined by the protocol, starting at
screening, throughout the study period and for 45 days after the final study drug
administration.
Exclusion Criteria:
- Patient has a diagnosis of Acute Promyelocytic Leukemia (APL) or chronic myelogenous
leukemia in blast crisis.
- If patient is post allogenic transplant and requires therapy for graft vs host disease
(GVHD) within 14 days prior to date of screening.
- Requires treatment with concomitant drugs that prolong QT/QTc interval.
- Recent history of cardiac ischemic disease (acute myocardial infarction within 6
months; uncontrolled angina); severe uncontrolled ventricular arrhythmia; recent
transient ischemic attack or stroke within 6 months of screening; poorly controlled
hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm
Hg).
- Patient has active, untreated central nervous system (CNS) disease.
Other protocol defined inclusion/exclusion criteria could apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recommended phase 2 dose (RP2D) |
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 |
Safety Issue: | |
Description: | RP2D of SKI-G-801 determined using Neuenschwander's continual reassessment method (N-CRM) |
Secondary Outcome Measures
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 30 days following last dose of study drug |
Safety Issue: | |
Description: | 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 |
Measure: | Number of participants with clinical laboratory abnormalities |
Time Frame: | Up to 30 days following last dose of study drug |
Safety Issue: | |
Description: | |
Measure: | Number of participants with overall safety profiles |
Time Frame: | Up to 30 days following last dose of study drug |
Safety Issue: | |
Description: | |
Measure: | Number of participants with electrocardiogram (ECG) abnormalities |
Time Frame: | Up to 30 days following last dose of study drug |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Oscotec Inc. |
Last Updated
October 28, 2019