FTS Study in Patients With Advanced Hematologic Malignancies

NCT00867230 | Completed Phase 1

• 1 other identifier: 2006-0201
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome; Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  Continous assessment throughout study and determination of dose limiting toxicities with each 28 day cycle.

Study Arms (1)

FTS (S-trans, trans-farnesylthiosalicylic acid)

EXPERIMENTAL

Drug: FTS

Interventions

FTS DRUG

Starting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle.

Also known as: S-trans, trans-farnesylthiosalicylic

FTS (S-trans, trans-farnesylthiosalicylic acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Patients are eligible if they are 18 years or older
• 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
• Patients with active CNS disease are included and will be treated concurrently with intrathecal therapy
• Patients must have ECOG performance status (PS) of 0 - 2
• 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.
• 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
• 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

You may not qualify if:

• 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
• Have an active uncontrolled infectious process
• 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)
• Have received prior radiotherapy administered to more than 30% of marrow-bearing bone mass
• Women patients are pregnant or lactating
• Patients who have had major surgery without full recovery or major surgery within three weeks of FTS treatment start
• 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
• Patients unwilling or unable to comply with the protocol

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Concordia Pharmaceuticals, Inc: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Laheru D, Shah P, Rajeshkumar NV, McAllister F, Taylor G, Goldsweig H, Le DT, Donehower R, Jimeno A, Linden S, Zhao M, Song D, Rudek MA, Hidalgo M. Integrated preclinical and clinical development of S-trans, trans-Farnesylthiosalicylic Acid (FTS, Salirasib) in pancreatic cancer. Invest New Drugs. 2012 Dec;30(6):2391-9. doi: 10.1007/s10637-012-9818-6. Epub 2012 May 1.

  PMID: 22547163 DERIVED

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Primary Myelofibrosis

Interventions

farnesylthiosalicylic acid

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Myeloproliferative Disorders

Study Officials

• Gautam Borthakur, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: May 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)