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FTS Study in Patients With Advanced Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT00867230
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : August 1, 2012
Sponsor:
Collaborator:
Concordia Pharmaceuticals, Inc
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Primary Objective:

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 or disease Intervention/treatment Phase
Myelodysplastic Syndrome Leukemia Drug: FTS Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009


Arm Intervention/treatment
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.
Other Name: S-trans, trans-farnesylthiosalicylic




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: Continous assessment throughout study and determination of dose limiting toxicities with each 28 day cycle. ]


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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:

  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

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): NCT00867230


Locations
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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
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Principal Investigator: Gautam Borthakur, MD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00867230    
Other Study ID Numbers: 2006-0201
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012
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
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Site