Advanced MelanomaPhase 2NCT01064713
Phase II Study of Tesetaxel in Metastatic Melanoma
A Phase 2 study testing Tesetaxel in people with Advanced Melanoma and Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma, Cancer
- What is being tested?
- Tesetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age.
- Histologically confirmed diagnosis of melanoma.
- Progressive disease that is not surgically resectable, or metastatic Stage IV disease.
- Measurable disease.
- Serum LDH </= 1.1 times the upper limit of normal (x ULN).
- Eastern Cooperative Oncology Group performance status 0 or 1.
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- Treatment with 1 prior regimen (including cytotoxic chemotherapy, immunotherapy, radiation therapy, or cytokine, biologic, or vaccine therapy) as first-line treatment for metastatic disease. (Administration of interleukin-2 or interferon as adjuvant therapy is allowed and is not to be considered in determining the 1 prior treatment regimen administered as first-line treatment for metastatic disease.)
- Adequate bone marrow, hepatic, and renal function, as evidenced by: a) Absolute neutrophil count (ANC) >/= 1500/mm^3; b) Platelet count >/= 100,000/mm^3; c) Hemoglobin >/= 9 g/dL without need for hematopoietic growth factor or transfusion support; d) Aspartate aminotransferase (AST) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN; e) Alanine aminotransferase (ALT) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN f. Total bilirubin </= 1.5 x ULN;
- (Continued # 8) g) Alkaline phosphatase </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN or, in the presence of bone metastasis, </= 10 x ULN; h) Serum creatinine </= 1.5 x ULN; i) Serum albumin >/= 3.0 g/dL; j) Prothrombin time (PT) </= 1.5 x ULN (or international normalized ratio [international normalized ratio (INR)] </=1.3); k) Partial thromboplastin time (PTT) </= 1.5 x ULN.
- At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent.
- Ability to swallow an oral solid-dosage form of medication.
- A negative serum pregnancy test within 7 days prior to the first dose of study medication in women of childbearing potential (that is, all women except for those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization).
- Agreement to use a highly effective form of contraception (ie, one that has a failure rate of < 1%) throughout the treatment phase of the study in women of childbearing potential (that is, all women excluding those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization) and sexually active men
- Written informed consent and authorization to use and disclose health information.
- Ability to comprehend and to comply with the requirements of the study.
Who cannot join
- History or presence of brain metastasis or leptomeningeal disease.
- Primary ocular or mucosal melanoma.
- Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
- Human immunodeficiency virus infection based on history of positive serology.
- Significant medical disease other than cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
- Organ allograft.
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- Presence of neuropathy > Grade 1.
- Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid.
- Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy.
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity.
- Less than 2 weeks since use of a medication or ingestion of an agent that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH
The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
Tesetaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 Groups based on when you enroll in this study. Each group has 2 "stages."
Group A:
A total of 27 patients will be enrolled in Group A and will receive a 40mg dose of tesetaxel, adjusted for individual body weight. For Group A, 13 patients will be enrolled in Stage 1. If at least 1 patient has a response to the 40 mg dose of tesetaxel, 14 additional patients will be enrolled in Stage 2 at the same dose level.
Group B:
A total of 27 patients will be enrolled in Group B and will receive a 50mg dose of tesetaxel, adjusted for individual body weight. For Group B, 13 patients will be enrolled in Stage 1 while researchers are waiting to see if patients in Group A respond to the study drug. If at least 1 patient has a response to the 50 mg dose of tesetaxel, 14 additional patients will be enrolled in Stage 2 at the same dose level.
Study Drug Administration:
No matter which Group you are assigned to, you will take tesetaxel capsules by mouth in the morning with water (6 ounces) on Day 1 of each 21-day study cycle. You must not eat or drink anything except water (fast) for at least 4 hours before taking tesetaxel. After fasting for 4 hours and taking tesetaxel, you may eat an average sized meal.
Before you take tesetaxel, you will receive drugs to prevent nausea and vomiting. The study doctor will discuss this with you. If you have a rash or allergic reaction, you may be receive an antihistamine and/or corticosteroid. If you develop a low number of white blood cells or red blood cells, you may be given growth factor drugs or receive transfusions. These drugs may be given by mouth or vein.
Study Visits:
On Day 1 of all Cycles:
-Your medical history, including any side effects you may have had and any drugs you may be taking, will be recorded.
On Day 9 (+/- 1 day) and again on Day 20 (+/- 2 days) of all Cycles:
- Any side effects you may have had and any drugs you may be taking will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Within 5 days before the start of cycles 3, 5, 7 and every other cycle thereafter:
- You will have a CT scan of the chest, stomach, and hip areas.
- Photographs of any melanoma on your skin will be taken.
- Any side effects you may have had and any drugs you may be taking will be recorded.
After the last dose of tesetaxel, blood (about 2 teaspoons) will be drawn for routine tests.
Within 3 weeks after the last dose of tesetaxel:
- You will have a CT scan of the chest, stomach, and hip areas.
- Photographs of any melanoma on your skin will be taken.
- Any side effects you may have had and any drugs you may be taking, will be recorded.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Follow-Up Visits:
If the melanoma does not get worse while you are on study, you will have visits every 2 months for up to 12 months after your first dose of study drug. At these visits:
- You will have a CT scan of the chest, stomach, and hip areas.
- Photographs of any melanoma on your skin will be taken.
- Any side effects you may have had and any drugs you may be taking, will be recorded.
- You will be asked about any treatment you may be receiving.
If the disease gets worse while you are on study, you will have follow up phone calls every 2 months for up to 12 months after your first dose of study drug. During these calls, you will be asked how you are feeling and about any therapy you are receiving. These calls should take about 5 minutes.
This is an investigational study. Tesetaxel is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 54 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Melanoma, Cancer
- Being tested
- Tesetaxel
- Keywords
- Tesetaxel, Second-line therapy, Metastatic melanoma, Normal serum LDH
- Medical subject headings
- Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesetaxelDrug
Cohort A: 40 mg by mouth every 21 days.
Cohort B. 50 mg by mouth every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Tesetaxel | Experimental | Therapy initiated at a flat dose of 40 mg for subjects in Cohort A and at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months. Receives: Drug: Tesetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)
Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.
Measured: Day 84
Number of Participants With Response
Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genta Incorporated
- Responsible party
- Sponsor
- Investigators
- Agop Y. Bedikian, MD, BS, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064713
- Sponsor's protocol ID
- 2009-0624
- Other IDs
- NCI-2011-00557
- Status last verified
- Jul 2018
- First submitted
- 5 Feb 2010
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH
- ClinicalTrials.gov ID
- NCT01064713
- Acronym / sponsor ID
- 2009-0624
- Conditions
- Advanced Melanoma, Cancer
- Keywords
- Tesetaxel, Second-line therapy, Metastatic melanoma, Normal serum LDH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genta Incorporated
- Study start
- Feb 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.
Detailed description
The Study Drug:
Tesetaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 Groups based on when you enroll in this study. Each group has 2 "stages."
Group A:
A total of 27 patients will be enrolled in Group A and will receive a 40mg dose of tesetaxel, adjusted for individual body weight. For Group A, 13 patients will be enrolled in Stage 1. If at least 1 patient has a response to the 40 mg dose of tesetaxel, 14 additional patients will be enrolled in Stage 2 at the same dose level.
Group B:
A total of 27 patients will be enrolled in Group B and will receive a 50mg dose of tesetaxel, adjusted for individual body weight. For Group B, 13 patients will be enrolled in Stage 1 while researchers are waiting to see if patients in Group A respond to the study drug. If at least 1 patient has a response to the 50 mg dose of tesetaxel, 14 additional patients will be enrolled in Stage 2 at the same dose level.
Study Drug Administration:
No matter which Group you are assigned to, you will take tesetaxel capsules by mouth in the morning with water (6 ounces) on Day 1 of each 21-day study cycle. You must not eat or drink anything except water (fast) for at least 4 hours before taking tesetaxel. After fasting for 4 hours and taking tesetaxel, you may eat an average sized meal.
Before you take tesetaxel, you will receive drugs to prevent nausea and vomiting. The study doctor will discuss this with you. If you have a rash or allergic reaction, you may be receive an antihistamine and/or corticosteroid. If you develop a low number of white blood cells or red blood cells, you may be given growth factor drugs or receive transfusions. These drugs may be given by mouth or vein.
Study Visits:
On Day 1 of all Cycles:
-Your medical history, including any side effects you may have had and any drugs you may be taking, will be recorded.
On Day 9 (+/- 1 day) and again on Day 20 (+/- 2 days) of all Cycles:
- Any side effects you may have had and any drugs you may be taking will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Within 5 days before the start of cycles 3, 5, 7 and every other cycle thereafter:
- You will have a CT scan of the chest, stomach, and hip areas.
- Photographs of any melanoma on your skin will be taken.
- Any side effects you may have had and any drugs you may be taking will be recorded.
After the last dose of tesetaxel, blood (about 2 teaspoons) will be drawn for routine tests.
Within 3 weeks after the last dose of tesetaxel:
- You will have a CT scan of the chest, stomach, and hip areas.
- Photographs of any melanoma on your skin will be taken.
- Any side effects you may have had and any drugs you may be taking, will be recorded.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Follow-Up Visits:
If the melanoma does not get worse while you are on study, you will have visits every 2 months for up to 12 months after your first dose of study drug. At these visits:
- You will have a CT scan of the chest, stomach, and hip areas.
- Photographs of any melanoma on your skin will be taken.
- Any side effects you may have had and any drugs you may be taking, will be recorded.
- You will be asked about any treatment you may be receiving.
If the disease gets worse while you are on study, you will have follow up phone calls every 2 months for up to 12 months after your first dose of study drug. During these calls, you will be asked how you are feeling and about any therapy you are receiving. These calls should take about 5 minutes.
This is an investigational study. Tesetaxel is not FDA approved or commercially available. It is currently being used for research purposes only.
Up to 54 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tesetaxel | Experimental | Drug: TesetaxelTherapy initiated at a flat dose of 40 mg for subjects in Cohort A and at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- At least 18 years of age.
- Histologically confirmed diagnosis of melanoma.
- Progressive disease that is not surgically resectable, or metastatic Stage IV disease.
- Measurable disease.
- Serum LDH </= 1.1 times the upper limit of normal (x ULN).
Key exclusion criteria (12 listed)
- History or presence of brain metastasis or leptomeningeal disease.
- Primary ocular or mucosal melanoma.
- Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
- Human immunodeficiency virus infection based on history of positive serology.
- Significant medical disease other than cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
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 |
|---|---|---|
| TesetaxelCohort A: 40 mg by mouth every 21 days. Cohort B. 50 mg by mouth every 21 days. | Drug | Tesetaxel |
Primary outcome
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)
Time frame: Day 84
Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.
Number of Participants With Response
Time frame: Day 84
Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to < 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas 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.
Agop Y. Bedikian, MD, BS study chair
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 2 study testing Tesetaxel in people with Advanced Melanoma and Cancer, 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 15 inclusion and 12 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 17 Jul 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response) (time frame: Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.