Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery (NCT NCT00738361)

Last Updated: 2016-02-12

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

up to 1 year following last treatment, for a total of approximately 5 years

Results posted on

2016-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Nab-paclitaxel Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NAb-paclitaxel n=4 Participants Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	4 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	4 participants n=99 Participants

PRIMARY outcome

Timeframe: up to 1 year following last treatment, for a total of approximately 5 years

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=4 Participants Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Overall Response Rate	0 patients

SECONDARY outcome

Timeframe: up to 1 year following last treatment, for a total of approximately 5 years

Population: all patients progressed at the time of first scan

Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=4 Participants Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Progression-free Survival	6.2 months Interval 1.7 to 13.0

SECONDARY outcome

Timeframe: up to 1 year following last treatment, for a total of approximately 5 years

Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel n=4 Participants Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Overall Survival	6.1833 months Standard Error 0.8369

Adverse Events

NAb-paclitaxel

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NAb-paclitaxel n=4 participants at risk Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	50.0% 2/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Metabolism and nutrition disorders Anorexia	50.0% 2/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Metabolism and nutrition disorders Hypocalcemia	50.0% 2/4 • Number of events 5 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 3 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Investigations Creatinine	25.0% 1/4 • Number of events 6 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Skin and subcutaneous tissue disorders Dermatology Skin	75.0% 3/4 • Number of events 7 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Gastrointestinal disorders Diarrhea	75.0% 3/4 • Number of events 8 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	25.0% 1/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
General disorders Edema: limb	25.0% 1/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Endocrine disorders Hypothyroidism	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
General disorders Fatigue	100.0% 4/4 • Number of events 10 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Gastrointestinal disorders Flatulence	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Skin and subcutaneous tissue disorders Alopecia	75.0% 3/4 • Number of events 5 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Blood and lymphatic system disorders Hemoglobin	75.0% 3/4 • Number of events 9 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Gastrointestinal disorders Hemorrhage	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Reproductive system and breast disorders Hemorrhage	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	50.0% 2/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Vascular disorders Hypotension	50.0% 2/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils	50.0% 2/4 • Number of events 4 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Blood and lymphatic system disorders Leukocytes (total WBC)	100.0% 4/4 • Number of events 27 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Blood and lymphatic system disorders Venous insuffiency	25.0% 1/4 • Number of events 1 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Blood and lymphatic system disorders Lymphopenia	50.0% 2/4 • Number of events 13 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Metabolism and nutrition disorders Alanine Aminotransferase (ALT)	75.0% 3/4 • Number of events 9 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Metabolism and nutrition disorders Aspartate aminotransferase (AST)	100.0% 4/4 • Number of events 8 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Infections and infestations Infection with Normal ANC or Grade 1 or 2 Neutrophils	25.0% 1/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Infections and infestations Infection with normal ANC or Grade 1 or 2 Neutrophils	25.0% 1/4 • Number of events 2 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Gastrointestinal disorders Nausea	75.0% 3/4 • Number of events 6 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Nervous system disorders Sensory Neuropathy	75.0% 3/4 • Number of events 5 The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting

Additional Information

Thomas Olencki, D.O.

Ohio State University Comprehensive Cancer Center

Phone: 614-293-2886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place