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Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT03564288
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Oscotec Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: SKI-G-801 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Trial of SKI-G-801 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Dose Escalation Cohort
To identify the recommended phase 2 dose (RP2D) of SKI-G-801 in patients with relapsed or refractory AML (Acute Myeloid Leukemia)
Drug: SKI-G-801
SKI-G-801 is administered as an IV infusion over 10 minutes




Primary Outcome Measures :
  1. 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 ]
    RP2D of SKI-G-801 determined using Neuenschwander's continual reassessment method (N-CRM)

  2. Patients in complete remission or showing partial response (overall response rate [ORR]) [ Time Frame: Up to 30 days following last dose of study drug ]
    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

  3. Patients in complete remission [ Time Frame: Day 84 (± 3 days) ]
    Number of patients showing complete remission (CR)

  4. Duration of remission [ 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 ]
    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

  5. Duration of event free survival [ 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 ]
    Number of days between start of treatment to date of event

  6. Time to treatment response (TTR) [ Time Frame: Day 1 to date of first subsequent disease status of CR (+ 1 day), assessed up to 36 months ]
    Number of days between the start of treatment to the date of first subsequent disease status of complete remission (CR)

  7. Dose limiting toxicity (DLT) Adverse Events (AEs) [ Time Frame: Up to Day 28 ]
    Number of any DLT AEs within the first cycle of each patient's treatment with SKI-G-801


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 30 days following last dose of study drug ]
    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

  2. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 30 days following last dose of study drug ]
  3. Number of participants with overall safety profiles [ Time Frame: Up to 30 days following last dose of study drug ]
  4. Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 30 days following last dose of study drug ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564288


Contacts
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Contact: Eunice Wang, MD 716-275-1124 suman.sarker@roswellpark.org
Contact: Suman Sarker 716-845-4886 suman.sarker@roswellpark.org

Locations
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United States, California
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Arati Chand, MD    562-693-4477    achand@AIResearch.us   
Contact: Kirsten Bettino, CCRP    562-693-4477    kbettino@AIResearch.us   
United States, New York
Roswell Park Cancer Institute, Elm & Carlton Streets Recruiting
Buffalo, New York, United States, 14263
Contact: Eunice Wang    716-275-1124      
Contact: Suman Sarker    716-845-4886    suman.sarker@roswellpark.org   
Principal Investigator: Eunice Wang         
Sponsors and Collaborators
Oscotec Inc.
PPD
Investigators
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Principal Investigator: Eunice Wang, MD Roswell Park Cancer Institute

Additional Information:
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Responsible Party: Oscotec Inc.
ClinicalTrials.gov Identifier: NCT03564288     History of Changes
Other Study ID Numbers: OSCO-P1301
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms