Clinical trial NCT01064713
Conditions: Advanced Melanoma Cancer
Keywords: Tesetaxel Second-line therapy Metastatic melanoma Normal serum LDH
Sponsor: M.D. Anderson Cancer Center
Start date: 2010-02-01; Completion date: 2014-10-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

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.

Arms: arm 1: 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.
Interventions: intervention 1: Tesetaxel
Intervention descriptions: intervention 1: Cohort A: 40 mg by mouth every 21 days.

Cohort B. 50 mg by mouth every 21 days.

Protocol documents: