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OSCO-P1301: A Phase 1 Dose Escalation Trial of SKI-G-801 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Description

This Phase 1 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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objectives of this study are:

  • Recommended phase 2 dose (RP2D)
  • Patients in complete remission or showing partial response
  • Patients in complete remission
  • Duration of remission
  • Duration of event-free survival
  • Time-to-treatment response (TTR)
  • Dose-limiting toxicity (DLT) Adverse Events (AEs)

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are willing and able to provide written informed consent for participation, prior to completing any study-related procedures
  • Have a diagnosis of Acute Myeloid Leukemia (AML)
  • Have been off previous anti-leukemia therapy for at least two weeks or five half-lives, whichever is longer if the immediate prior regimen included only weekly chemotherapy; or four weeks or five half-lives, whichever is longer, from any therapy with therapeutic biologics and from any type of investigational therapy. Daily hydroxyurea for up to two 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.
  • Have had 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
  • Are female patients who are either of non-child-bearing potential or, if of child-bearing 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 child-bearing potential, if heterosexually active, must agree to use two 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.
  • Are female patients who agree not to breastfeed at screening, throughout the study period, and for 45 days after the final study drug administration
  • Are male patients with female spouses/partners of child-bearing potential who agree to use two 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

Excluding patients who: 

  • Have had a diagnosis of Acute Promyelocytic Leukemia (APL) or chronic myelogenous leukemia in blast crisis
  • Are post-allogenic transplant and require therapy for graft versus host disease (GVHD) within 14 days prior to the date of screening
  • Require treatment with concomitant drugs that prolong QT/QTc interval
  • Have a recent history of cardiac ischemic disease (acute myocardial infarction within six months; uncontrolled angina); severe uncontrolled ventricular arrhythmia; recent transient ischemic attack or stroke within six months of screening; poorly controlled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg)
  • Have active, untreated central nervous system (CNS) disease

Other protocol-defined inclusion-exclusion criteria could apply.