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A Study of APTO-253 HCl in Patients With Relapsed or Refractory Hematologic Malignancies

This study has suspended participant recruitment.
(Drug manufacturing process and procedure review)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02267863
First Posted: October 20, 2014
Last Update Posted: November 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aptose Biosciences Inc.
  Purpose
This is a phase 1b study to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT) and recommended phase 2 dose of APTO-253 HCl in patients with relapsed or refractory hematologic malignancies.

Condition Intervention Phase
Relapsed Hematologic Malignancies Refractory Hematologic Malignancies Drug: APTO-253 HCl Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation With Two Disease Specific Expansions, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of LOR-253 in Patients With Relapsed or Refractory Hematologic Malignancies

Further study details as provided by Aptose Biosciences Inc.:

Primary Outcome Measures:
  • Maximum tolerated dose and dose limiting toxicities [ Time Frame: 4 weeks ]
    To determine the maximum tolerated dose and the dose limiting toxicities of APTO-253 HCl with twice weekly dosing in a 28-day cycle to establish the dose recommended for future phase 2 studies for patients with hematologic malignancies.


Secondary Outcome Measures:
  • Pharmacokinetic variables including Cmax, Css, AUC and Kel [ Time Frame: Cycle 1 (28 days) ]
  • Change from baseline of KLF4, CDX2 and p21 pharmacodynamic variables [ Time Frame: Average 2 Cycles (8 weeks) ]

Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose escalation and expansion
APTO-253 HCl will be given in ascending doses in patients with acute leukemia, myelodysplastic syndrome, lymphoma or multiple myeloma until the maximum administered dose or appropriate dose is reached. Enrollment of approximately up to 15 patients with acute leukemia or myelodysplastic syndrome and 15 patients with lymphoma or multiple myeloma is anticipated in the dose escalation portion, followed by up to 30 patients enrolled in the expansion cohort at the recommended dose in two specific indications selected from the dose escalation experience.
Drug: APTO-253 HCl
APTO-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate dose is reached. Patients will be treated on APTO-253 HCl for at least 1 cycle (28 days) for safety evaluation.
Other Name: Formerly LOR-253 HCl

Detailed Description:
This is an open label, phase 1b dose escalation with two disease specific expansions, multicenter, safety, pharmacokinetic and pharmacodynamic study to determine the maximum tolerated dose (MTD) or appropriate dose if MTD not reached to identify the recommended phase 2 dose of APTO-253 HCl in patients with relapsed or refractory hematologic malignancies.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female 18 years of age or older
  • Histologically or cytologically proven diagnosis of hematologic malignancies for whom all standard therapy options have failed
  • Meet laboratory parameter requirements at study entry

Exclusion Criteria:

  • Pregnancy or breast feeding
  • History of prior malignancy
  • Auto-immune hemolytic anemia
  • Acute Promyelocytic Leukemia
  • Uncontrolled and clinically significant disease-related metabolic disorder
  • Other serious illness or medical conditions
  • Patients who have exhibited allergic reactions to compounds structurally similar to APTO-253 HCl
  Contacts and Locations
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): NCT02267863


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Aptose Biosciences Inc.
  More Information

Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT02267863     History of Changes
Other Study ID Numbers: 253-HEM1-01
First Submitted: October 3, 2014
First Posted: October 20, 2014
Last Update Posted: November 25, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Neoplasms