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FTS Study in Patients With Advanced Hematologic Malignancies
This study has been completed.
First Received: March 20, 2009   No Changes Posted
Sponsors and Collaborators: M.D. Anderson Cancer Center
Concordia Pharmaceuticals, Inc
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00867230
  Purpose

Primary Objective:

1. Determining the maximum tolerated dose (MTD) and pharmacokinetics (PK) of FTS (S-Trans, Trans-Farnesylthiosalicylic Acid) after daily oral administration on Days 1 through 21 of a 28-Day cycle to patients with advanced hematologic malignancies that have progressed following effective therapy or for which no effective therapy exists.


Condition Intervention Phase
Myelodysplastic Syndrome
Leukemia
Drug: FTS
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Open-Label Study of S-Trans, Trans-Farnesylthiosalicylic Acid (FTS) Administered on Days 1 to 21 of a 28 Day Cycle in Patients With Advanced Hematologic Malignancies

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Find highest tolerable dose of trans-farnesylthiosalicylic acid (FTS) that can be given to treat leukemia, myelodysplastic syndrome, or myelofibrosis. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine how FTS is being processed by body and how FTS works against leukemia cells. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: May 2006
Study Completion Date: February 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
FTS (S-trans, trans-farnesylthiosalicylic acid)
Drug: FTS
Starting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have relapsed/refractory hematologic malignancies for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy. Patients with poor-risk myelodysplastic syndromes (MDS) [IPSS ≥ 1.5], chronic myelomonocytic leukemia (CMML), relapsed/refractory leukemias including
  2. CONTINUATION OF # 1: acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blastic phase, or with agnogenic myeloid metaplasia (AMM) are eligible.
  3. Patients are eligible if they are 18 years or older
  4. In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. Persistent chronic clinically significant toxicities from prior chemotherapy must not be greater than Grade 1
  5. Patients with active CNS disease are included and will be treated concurrently with intrathecal therapy
  6. Patients must have ECOG performance status (PS) of 0 - 2
  7. Have serum creatinine less than or equal to 2.0 mg/dl; total bilirubin less than or equal to 2.0 mg/dl; ALT and/or AST no more than 3X the upper limit of normal range unless abnormal parameter level is considered related to leukemia.
  8. Patients must be willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study
  9. Females of childbearing potential and males are required to practice adequate contraception or abstinence prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion Criteria:

  1. Impaired cardiac function, including any one of the following: myocardial infarction within the previous 3 months; symptomatic coronary insufficiency or heart block; uncontrolled congestive heart failure; moderate or severe pulmonary dysfunction
  2. Have an active uncontrolled infectious process
  3. Significant impairment of gastrointestinal (GI) function of GI disease that may significantly alter the absorption of FTS(e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  4. Have received prior radiotherapy administered to more than 30% of marrow-bearing bone mass
  5. Women patients are pregnant or lactating
  6. Patients who have had major surgery without full recovery or major surgery within three weeks of FTS treatment start
  7. Patients with marked baseline prolongation of QT/QTc interval (QTc interval greater than 480) using the Fridericia method as a main method of QTC analysis
  8. Patients unwilling or unable to comply with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867230

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Concordia Pharmaceuticals, Inc
Investigators
Principal Investigator: Gautam Borthakur, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Gautam Borthakur, MBBS / Assistant Professor )
Study ID Numbers: 2006-0201
Study First Received: March 20, 2009
Last Updated: March 20, 2009
ClinicalTrials.gov Identifier: NCT00867230     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia
Acute Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Agnogenic Myeloid Metaplasia
FTS
S-Trans, Trans-Farnesylthiosalicylic Acid

Study placed in the following topic categories:
Chronic Myelomonocytic Leukemia
Leukemia, Lymphoid
Myelofibrosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Precancerous Conditions
Hematologic Neoplasms
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Farnesylthiosalicylic acid
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myeloid Metaplasia
Leukemia
Chronic Lymphocytic Leukemia
Acute Myelocytic Leukemia
Preleukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Metaplasia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Leukemia, B-cell, Chronic
Bone Marrow Diseases
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Hematologic Neoplasms
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Farnesylthiosalicylic acid
Myelodysplastic Syndromes
Enzyme Inhibitors
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009