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Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

Primary Purpose

Leukemias, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sapacitabine
Sponsored by
Cyclacel Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients with advanced leukemias or myelodysplastic syndromes defined in section 4.1; Eastern Cooperative Oncology Group performance status 0-2; adequate hepatic and renal function; ability to swallow capsules; be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery or other investigational anticancer therapy; and have recovered from prior toxicities.

Exclusion Criteria:

  • Patients with known CNS involvement by leukemia; plan to undergo allogeneic bone marrow transplant within 4 weeks; currently on other investigational agents; uncontrolled intercurrent illnesses; pregnant or lactating women; known to be HIV positive

Sites / Locations

  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sapacitabine low dose

sapacitabine high dose

Arm Description

sapacitabine administered every 12 hours for 7 days followed by 14 days of rest or every 12 hours for 3 consecutive days per week for 2 weeks followed by 7 days of rest in patients with advanced leukemias or myelodysplastic syndromes The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest; Evaluated doses: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg

The starting dose is 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses: 375mg, 425mg and 475mg

Outcomes

Primary Outcome Measures

Maximum tolerated dose
dose limiting toxicities; during first cycle, each cycle is three weeks

Secondary Outcome Measures

Full Information

First Posted
September 23, 2006
Last Updated
December 7, 2021
Sponsor
Cyclacel Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00380653
Brief Title
Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes
Official Title
A Phase I Pharmacologic Study of Oral Sapacitabine in Patients With Advanced Leukemias or Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
The goal of this safety/pharmacology study is to determine MTD of sapacitabine when administered in patients with advanced leukemias or myelodysplastic syndromes.
Detailed Description
The goal of this study is to find the highest tolerable dose of sapacitabine that can be given to patients with advanced leukemias or myelodysplastic syndromes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemias, Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest or, (B) 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses in schedule A: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg Evaluated doses in schedule B: 375mg, 425mg and 475mg
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sapacitabine low dose
Arm Type
Experimental
Arm Description
sapacitabine administered every 12 hours for 7 days followed by 14 days of rest or every 12 hours for 3 consecutive days per week for 2 weeks followed by 7 days of rest in patients with advanced leukemias or myelodysplastic syndromes The starting dose is (A) 75 mg twice daily x 7 days followed by 14 days of rest; Evaluated doses: 75mg, 100mg, 125mg, 175mg, 225mg, 275mg, 325mg and 375mg
Arm Title
sapacitabine high dose
Arm Type
Experimental
Arm Description
The starting dose is 375 mg twice daily x 3 consecutive days per week for 2 weeks followed by 7days of rest. Evaluated doses: 375mg, 425mg and 475mg
Intervention Type
Drug
Intervention Name(s)
sapacitabine
Other Intervention Name(s)
CYC682
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
dose limiting toxicities; during first cycle, each cycle is three weeks
Time Frame
Through study completion, average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with advanced leukemias or myelodysplastic syndromes defined in section 4.1; Eastern Cooperative Oncology Group performance status 0-2; adequate hepatic and renal function; ability to swallow capsules; be at least 2 weeks from prior chemotherapy, radiation therapy, major surgery or other investigational anticancer therapy; and have recovered from prior toxicities. Exclusion Criteria: Patients with known CNS involvement by leukemia; plan to undergo allogeneic bone marrow transplant within 4 weeks; currently on other investigational agents; uncontrolled intercurrent illnesses; pregnant or lactating women; known to be HIV positive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy H Chiao, MD
Organizational Affiliation
Cyclacel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19933907
Citation
Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Ravandi F, Westwood R, Green SR, Chiao JH, Boone PA, Cortes J, Plunkett W. Phase I clinical and pharmacokinetic study of oral sapacitabine in patients with acute leukemia and myelodysplastic syndrome. J Clin Oncol. 2010 Jan 10;28(2):285-91. doi: 10.1200/JCO.2009.25.0209. Epub 2009 Nov 23.
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Safety and Pharmacology Study of Sapacitabine to Treat Advanced Leukemias or Myelodysplastic Syndromes

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