Trial Outcomes & Findings for Phase II Study of Tesetaxel in Metastatic Melanoma (NCT NCT01064713)

Last Updated: 2018-07-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Day 84

Results posted on

2018-07-17

Participant Flow

Recruitment period: August 9, 2010 to July 12, 2012. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.

No participants were enrolled in Stage 2 of the study.

Participant milestones

Participant milestones
Measure	40 mg Tesetaxel, Cohort A Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. 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.	50 mg Tesetaxel, Cohort B Therapy initiated 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.
Overall Study STARTED	13	4
Overall Study COMPLETED	13	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Tesetaxel in Metastatic Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	40 mg Tesetaxel, Cohort A n=13 Participants Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. 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.	50 mg Tesetaxel, Cohort B n=4 Participants Therapy initiated 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.	Total n=17 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	64 years n=7 Participants	68 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	4 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 84

Outcome measures

Outcome measures
Measure	40 mg Tesetaxel, Cohort A n=13 Participants Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. 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.	50 mg Tesetaxel, Cohort B n=4 Participants Therapy initiated 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.
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response) Partial Response (PR)	0 percentage of participants	0 percentage of participants
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response) Progression (PD)	62.5 percentage of participants	50 percentage of participants
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response) Stable Disease (SD)	37.5 percentage of participants	50 percentage of participants
Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response) Complete Response (CR)	0 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Day 84

Outcome measures

Outcome measures
Measure	40 mg Tesetaxel, Cohort A n=13 Participants Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. 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.	50 mg Tesetaxel, Cohort B n=4 Participants Therapy initiated 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.
Number of Participants With Response Complete Response (CR)	0 participants	0 participants
Number of Participants With Response Partial Response (PR)	0 participants	0 participants
Number of Participants With Response Progression (PD)	8 participants	2 participants
Number of Participants With Response Stable Disease (SD)	5 participants	2 participants

Adverse Events

40 Tesetaxel, Cohort A

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

50 mg Tesetaxel, Cohort B

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Agop Y. Bedikian, MD/Professor

University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	40 Tesetaxel, Cohort A n=13 participants at risk Therapy initiated at a flat dose of 40 mg for subjects in Cohort A. 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.	50 mg Tesetaxel, Cohort B n=4 participants at risk Therapy initiated 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.
Gastrointestinal disorders anorexia	15.4% 2/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders nausea	15.4% 2/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders vomiting	15.4% 2/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders constipation	15.4% 2/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
General disorders fatigue	23.1% 3/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	75.0% 3/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Nervous system disorders peripheral neuropathies	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	75.0% 3/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Musculoskeletal and connective tissue disorders muscle weakness	15.4% 2/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders taste alteration	15.4% 2/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders stomatitis	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	25.0% 1/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders heartburn	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	25.0% 1/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Musculoskeletal and connective tissue disorders chills	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	25.0% 1/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
General disorders headaches	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	25.0% 1/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
Gastrointestinal disorders diarrhea	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	50.0% 2/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
General disorders pain	7.7% 1/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	25.0% 1/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.
General disorders weight loss	0.00% 0/13 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.	25.0% 1/4 • Initiation of therapy through end of treatment (through 30 days after the last dose of study medication), up to 7 cycles of 21 day therapy.