Myelodysplastic SyndromePhase 1NCT00867230
FTS Study in Patients With Advanced Hematologic Malignancies
A Phase 1 study testing FTS in people with Myelodysplastic Syndrome and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Leukemia
- What is being tested?
- FTS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this 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
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.
Read the detailed description
FTS is designed to interfere with a cancer cell's ability to reproduce.
Before you can start receiving the drug on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will be asked about any side effects that you are having and about any medications that you are taking. Your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature) will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will have an electrocardiogram (ECG - test to measure the electrical activity of the heart). A bone marrow aspirate and/or biopsy will be collected to check the status of the disease. To collect a bone marrow aspirate and/or biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount (about 1 teaspoon) of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood (about 1 tablespoon) or urine pregnancy test.
If you are found to be eligible for this study, you will take FTS by mouth, morning and night with food, on Days 1-21 of a 28-day study "cycle."
The amount of study drug you will receive will be based on when you enter the study. At least 3 participants will be taking FTS at the same dose level. Doses will be increased for the next group of 3 participants based on the side effects seen in the previous group. Each new group of participants will receive a higher dose level than the previous group, until a level is reached where side effects are considered to be intolerable.
After each cycle, your doctor may decide to increase your dose if you are not having intolerable side effects and you are benefitting from the study drug. If you experience intolerable side effects during any of the cycles of therapy with FTS, your dose may be reduced, delayed, or you may be taken off the study.
On Day 1 of the study, your weight and vital signs will be measured. Blood (about 1 tablespoon) will be collected for routine tests. You will not take your evening dose of FTS on Day 1.
On Days 8,15, and 22 of the first cycle, your weight and vital signs will be measured. You will be asked about any side effects that you are having, and about any medications that you are taking. On Day 15 of Cycle 1, blood (about 1 tablespoon) will also be drawn for routine tests.
During Cycle 1, on Days 1, 8, and 15, blood (about 1 tablespoon per draw) will be drawn to find out how much drug there is in your blood at different time points. This will help researchers to learn how FTS is processed by your body. This is called pharmacokinetic (PK) testing. Blood will be drawn before your morning dose of FTS, at 30, 60, and 90 minutes after taking the morning dose, and at 2, 4, 6, 8 and 24 hours after taking the morning dose. During Cycle 1, on Days 1 and 15, blood (about 3 tablespoons per draw) will be drawn to determine how FTS works against leukemia cells. This blood will be drawn before and 24 hours, after taking the morning dose on Day 1 and before you take the dose on Day 15.
On Day 1 of each cycle after Cycle 1, your weight and vital signs will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking.
On Days 8, 15, and 22 of every cycle after Cycle 1, you will be asked about any side effects that you are having and about any medications that you are taking. On Day 15, blood (about 1 tablespoon) will also be drawn for routine tests, and your weight and vital signs will be measured.
You may remain on study for as long as you are benefiting. You will be taken off study if you are not benefitting or if you are experiencing intolerable side effects.
Thirty (30) days after you are no longer taking the study drug, you will have an end-of-study visit. Blood (about 2 tablespoons) and urine will be collected for routine tests. Your weight and vital signs will be measured. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking. You will have an ECG and an evaluation of your disease, which may include a bone marrow aspiration and/or biopsy.
This is an investigational study. FTS is not FDA approved or commercially available, and it has been authorized for use in research only. Up to 30 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.
- Conditions
- Myelodysplastic Syndrome, Leukemia
- Being tested
- FTS
- 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
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTSDrug
Also called S-trans, trans-farnesylthiosalicylic
Starting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| FTS (S-trans, trans-farnesylthiosalicylic acid) | Experimental | Not described Receives: Drug: FTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Measured: Continous assessment throughout study and determination of dose limiting toxicities with each 28 day cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMay 2006
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Concordia Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Gautam Borthakur, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867230
- Sponsor's protocol ID
- 2006-0201
- Status last verified
- Jul 2012
- First submitted
- 20 Mar 2009
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22547163
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00867230
- Acronym / sponsor ID
- 2006-0201
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Concordia Pharmaceuticals, Inc
- Study start
- May 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
FTS is designed to interfere with a cancer cell's ability to reproduce.
Before you can start receiving the drug on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded, and you will have a physical exam. You will be asked about any side effects that you are having and about any medications that you are taking. Your weight and vital signs (blood pressure, heart rate, breathing rate, and temperature) will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will have an electrocardiogram (ECG - test to measure the electrical activity of the heart). A bone marrow aspirate and/or biopsy will be collected to check the status of the disease. To collect a bone marrow aspirate and/or biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount (about 1 teaspoon) of bone marrow and bone is withdrawn through a large needle. Women who are able to have children must have a negative blood (about 1 tablespoon) or urine pregnancy test.
If you are found to be eligible for this study, you will take FTS by mouth, morning and night with food, on Days 1-21 of a 28-day study "cycle."
The amount of study drug you will receive will be based on when you enter the study. At least 3 participants will be taking FTS at the same dose level. Doses will be increased for the next group of 3 participants based on the side effects seen in the previous group. Each new group of participants will receive a higher dose level than the previous group, until a level is reached where side effects are considered to be intolerable.
After each cycle, your doctor may decide to increase your dose if you are not having intolerable side effects and you are benefitting from the study drug. If you experience intolerable side effects during any of the cycles of therapy with FTS, your dose may be reduced, delayed, or you may be taken off the study.
On Day 1 of the study, your weight and vital signs will be measured. Blood (about 1 tablespoon) will be collected for routine tests. You will not take your evening dose of FTS on Day 1.
On Days 8,15, and 22 of the first cycle, your weight and vital signs will be measured. You will be asked about any side effects that you are having, and about any medications that you are taking. On Day 15 of Cycle 1, blood (about 1 tablespoon) will also be drawn for routine tests.
During Cycle 1, on Days 1, 8, and 15, blood (about 1 tablespoon per draw) will be drawn to find out how much drug there is in your blood at different time points. This will help researchers to learn how FTS is processed by your body. This is called pharmacokinetic (PK) testing. Blood will be drawn before your morning dose of FTS, at 30, 60, and 90 minutes after taking the morning dose, and at 2, 4, 6, 8 and 24 hours after taking the morning dose. During Cycle 1, on Days 1 and 15, blood (about 3 tablespoons per draw) will be drawn to determine how FTS works against leukemia cells. This blood will be drawn before and 24 hours, after taking the morning dose on Day 1 and before you take the dose on Day 15.
On Day 1 of each cycle after Cycle 1, your weight and vital signs will be measured. Blood (about 2 tablespoons) and urine will be collected for routine tests. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking.
On Days 8, 15, and 22 of every cycle after Cycle 1, you will be asked about any side effects that you are having and about any medications that you are taking. On Day 15, blood (about 1 tablespoon) will also be drawn for routine tests, and your weight and vital signs will be measured.
You may remain on study for as long as you are benefiting. You will be taken off study if you are not benefitting or if you are experiencing intolerable side effects.
Thirty (30) days after you are no longer taking the study drug, you will have an end-of-study visit. Blood (about 2 tablespoons) and urine will be collected for routine tests. Your weight and vital signs will be measured. You will be asked about your ability to perform everyday tasks. You will be asked about any side effects that you are having, and about any medications that you are taking. You will have an ECG and an evaluation of your disease, which may include a bone marrow aspiration and/or biopsy.
This is an investigational study. FTS is not FDA approved or commercially available, and it has been authorized for use in research only. Up to 30 patients will take part in this multicenter study. Up to 20 patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FTS (S-trans, trans-farnesylthiosalicylic acid) | Experimental | Drug: FTS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTSAlso: S-trans, trans-farnesylthiosalicylicStarting dose of 100 mg twice a day by mouth, Days 1 through 21 of a 28-day cycle. | Drug | FTS (S-trans, trans-farnesylthiosalicylic acid) |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: Continous assessment throughout study and determination of dose limiting toxicities with each 28 day cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Derived from this study: PubMed 22547163Laheru 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.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gautam Borthakur, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FTS in people with Myelodysplastic Syndrome and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: Continous assessment throughout study and determination of dose limiting toxicities with each 28 day cycle.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00867230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.