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

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ClinicalTrials.gov Identifier: NCT02267863
Recruitment Status : Suspended (Drug manufacturing process and procedure review)
First Posted : October 20, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Aptose Biosciences Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Relapsed Hematologic Malignancy Refractory Hematologic Malignancy Drug: APTO-253 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : October 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetic variables including Cmax [ Time Frame: Cycle 1 (28 Days) ]
  2. Pharmacokinetic variables including Css [ Time Frame: Cycle 1 (28 Days) ]
  3. Pharmacokinetic variables including AUC [ Time Frame: Cycle 1 (28 Days) ]
  4. Pharmacokinetic variables including Kel [ Time Frame: Cycle 1 (28 Days) ]
  5. Change from baseline of KLF4 pharmacodynamic variables [ Time Frame: Average 2 Cycles (8 weeks) ]
  6. Change from baseline of CDX2 pharmacodynamic variables [ Time Frame: Average 2 Cycles (8 weeks) ]
  7. Change from baseline of p21 pharmacodynamic variables [ Time Frame: Average 2 Cycles (8 weeks) ]


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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:

  • 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 HCI

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.

Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT02267863     History of Changes
Other Study ID Numbers: 253-HEM1-01
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Neoplasms