Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
Sponsor
Spectrum Pharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00506142
Collaborator
(none)
54
4
2
85
13.5
0.2
Study Details
Study Description
Brief Summary
Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously.
The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied.
Approximately 50 patients will take part in this study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
54 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Patients were enrolled into the study in two cohorts. After completion of enrollment in Cohort 1, enrollment in Cohort 2 has commenced.Patients were enrolled into the study in two cohorts. After completion of enrollment in Cohort 1, enrollment in Cohort 2 has commenced.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
Study Start Date
:
Nov 1, 2007
Actual Primary Completion Date
:
Dec 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. |
Drug: Marqibo® (vincristine sulfate liposomes injection)
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
| Experimental: Cohort 2 Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. |
Drug: Marqibo® (vincristine sulfate liposomes injection)
Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks.
Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week.
|
Outcome Measures
Primary Outcome Measures
- Disease Control Rate [1 year]
Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Uveal melanoma with histologic or cytologic confirmation of metastatic disease.
-
One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be >20 mm with conventional techniques or >10 mm with spiral CT scan. Bone lesions are not considered measurable.
-
Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease.
-
Adequate liver, renal, and bone marrow function.
-
Zubrod performance status of 0-2.
-
Sign an informed consent form.
Exclusion Criteria:
-
Major surgery within 4 weeks of enrollment.
-
Advanced symptomatic central nervous system (CNS) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis".
-
History of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).
-
Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any cause.
-
Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles | Los Angeles | California | United States | 90024 |
| 2 | University of Colorado, Denver | Denver | Colorado | United States | 80045 |
| 3 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 4 | University of Texas M.D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Spectrum Pharmaceuticals, Inc
Investigators
- Principal Investigator: Deborah Sanders, MD, MD Anderson
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00506142
Other Study ID Numbers:
- HBS408 (formerly IST401)
First Posted:
Jul 25, 2007
Last Update Posted:
Dec 11, 2019
Last Verified:
Nov 1, 2019
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1 | Cohort 2 |
|---|---|---|
| Arm/Group Description | Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. | Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. |
| Period Title: Overall Study | ||
| STARTED | 35 | 19 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 35 | 19 |
Baseline Characteristics
| Arm/Group Title | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Arm/Group Description | Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. | Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. | Total of all reporting groups |
| Overall Participants | 35 | 19 | 54 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
61.7
(11.43)
|
66.6
(7.97)
|
63.4
(10.53)
|
| Age, Customized (Count of Participants) | |||
| 18-29 years |
0
0%
|
0
0%
|
0
0%
|
| 30-59 years |
13
37.1%
|
3
15.8%
|
16
29.6%
|
| >=60 years |
22
62.9%
|
16
84.2%
|
38
70.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
77.1%
|
9
47.4%
|
36
66.7%
|
| Male |
8
22.9%
|
10
52.6%
|
18
33.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
35
100%
|
19
100%
|
54
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
5.3%
|
1
1.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
35
100%
|
18
94.7%
|
53
98.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Disease Control Rate |
|---|---|
| Description | Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD) |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cohort 1 | Cohort 2 |
|---|---|---|
| Arm/Group Description | Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. | Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. |
| Measure Participants | 35 | 19 |
| Count of Participants [Participants] |
18
51.4%
|
8
42.1%
|
Adverse Events
| Time Frame | 5 years | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Cohort 1 | Cohort 2 | ||
| Arm/Group Description | Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. | Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week Marqibo® (vincristine sulfate liposomes injection): Cohort 1 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every 2 weeks. Cohort 2 subjects will receive MARQIBO at a dose of 2.25 mg/m2 IV over 1 hour every week. | ||
All Cause Mortality |
||||
| Cohort 1 | Cohort 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cohort 1 | Cohort 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/35 (42.9%) | 9/19 (47.4%) | ||
| Blood and lymphatic system disorders | ||||
| NEUTROPENIA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Endocrine disorders | ||||
| INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Gastrointestinal disorders | ||||
| ILEUS | 2/35 (5.7%) | 2 | 1/19 (5.3%) | 1 |
| CONSTIPATION | 2/35 (5.7%) | 2 | 2/19 (10.5%) | 2 |
| ABDOMINAL PAIN | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| ASCITES | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| GASTRIC ILEUS | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| GASTRIC ULCER | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| ILEUS PARALYTIC | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| NAUSEA | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| VOMITING | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| General disorders | ||||
| DISEASE PROGRESSION | 1/35 (2.9%) | 1 | 2/19 (10.5%) | 2 |
| DEATH | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| PYREXIA | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| ASTHENIA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Hepatobiliary disorders | ||||
| HEPATIC FAILURE | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| Infections and infestations | ||||
| CENTRAL LINE INFECTION | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| KLEBSIELLA INFECTION | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| PNEUMONIA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| URINARY TRACT INFECTION | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| VASCULAR ACCESS COMPLICATION | 2/35 (5.7%) | 3 | 0/19 (0%) | 0 |
| Investigations | ||||
| BLOOD ALKALINE PHOSPHATASE INCREASED | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| HYPONATRAEMIA | 1/35 (2.9%) | 2 | 1/19 (5.3%) | 1 |
| DECREASED APPETITE | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| HYPERKALAEMIA | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| BACK PAIN | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| METASTATIC PAIN | 1/35 (2.9%) | 2 | 0/19 (0%) | 0 |
| Nervous system disorders | ||||
| ENCEPHALOPATHY | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
| Renal and urinary disorders | ||||
| RENAL FAILURE | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| RENAL FAILURE ACUTE | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| PULMONARY EMBOLISM | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 1 |
| DYSPNOEA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| PULMONARY OEDEMA | 1/35 (2.9%) | 1 | 0/19 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Cohort 1 | Cohort 2 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/35 (100%) | 19/19 (100%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 9/35 (25.7%) | 15 | 4/19 (21.1%) | 9 |
| LEUKOPENIA | 1/35 (2.9%) | 1 | 2/19 (10.5%) | 2 |
| THROMBOCYTOPENIA | 2/35 (5.7%) | 4 | 2/19 (10.5%) | 3 |
| Cardiac disorders | ||||
| CARDIAC FAILURE CONGESTIVE | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| SINUS TACHYCARDIA | 0/35 (0%) | 0 | 2/19 (10.5%) | 2 |
| Ear and labyrinth disorders | ||||
| EAR PAIN | 3/35 (8.6%) | 3 | 0/19 (0%) | 0 |
| Eye disorders | ||||
| VISUAL ACUITY REDUCED | 2/35 (5.7%) | 2 | 1/19 (5.3%) | 1 |
| Gastrointestinal disorders | ||||
| ABDOMINAL DISCOMFORT | 0/35 (0%) | 0 | 2/19 (10.5%) | 2 |
| ABDOMINAL DISTENSION | 3/35 (8.6%) | 4 | 5/19 (26.3%) | 5 |
| ABDOMINAL PAIN | 9/35 (25.7%) | 15 | 7/19 (36.8%) | 7 |
| ABDOMINAL PAIN UPPER | 2/35 (5.7%) | 2 | 5/19 (26.3%) | 5 |
| CONSTIPATION | 25/35 (71.4%) | 36 | 13/19 (68.4%) | 17 |
| DIARRHOEA | 16/35 (45.7%) | 22 | 5/19 (26.3%) | 6 |
| DRY MOUTH | 1/35 (2.9%) | 1 | 4/19 (21.1%) | 4 |
| DYSPEPSIA | 5/35 (14.3%) | 7 | 3/19 (15.8%) | 3 |
| FLATULENCE | 2/35 (5.7%) | 3 | 0/19 (0%) | 0 |
| GASTRITIS | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| HAEMORRHOIDS | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| NAUSEA | 21/35 (60%) | 39 | 10/19 (52.6%) | 12 |
| REGURGITATION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| VOMITING | 17/35 (48.6%) | 29 | 9/19 (47.4%) | 13 |
| General disorders | ||||
| ASTHENIA | 2/35 (5.7%) | 4 | 4/19 (21.1%) | 5 |
| CHEST DISCOMFORT | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| CHILLS | 6/35 (17.1%) | 11 | 3/19 (15.8%) | 3 |
| FATIGUE | 26/35 (74.3%) | 38 | 14/19 (73.7%) | 23 |
| FEELING OF BODY TEMPERATURE CHANGE | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 1 |
| GAIT DISTURBANCE | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| INFUSION SITE EXTRAVASATION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| MUCOSAL INFLAMMATION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| NON-CARDIAC CHEST PAIN | 4/35 (11.4%) | 4 | 1/19 (5.3%) | 2 |
| OEDEMA | 2/35 (5.7%) | 2 | 1/19 (5.3%) | 1 |
| OEDEMA PERIPHERAL | 3/35 (8.6%) | 3 | 3/19 (15.8%) | 4 |
| PAIN | 12/35 (34.3%) | 13 | 4/19 (21.1%) | 5 |
| PYREXIA | 16/35 (45.7%) | 30 | 5/19 (26.3%) | 7 |
| Hepatobiliary disorders | ||||
| HYPERBILIRUBINAEMIA | 4/35 (11.4%) | 8 | 2/19 (10.5%) | 4 |
| Immune system disorders | ||||
| DRUG HYPERSENSITIVITY | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Infections and infestations | ||||
| BRONCHITIS | 3/35 (8.6%) | 3 | 0/19 (0%) | 0 |
| FUNGAL INFECTION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| SINUSITIS | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| SKIN CANDIDA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| URINARY TRACT INFECTION | 1/35 (2.9%) | 1 | 2/19 (10.5%) | 2 |
| Injury, poisoning and procedural complications | ||||
| FALL | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Investigations | ||||
| ALANINE AMINOTRANSFERASE INCREASED | 0/35 (0%) | 0 | 4/19 (21.1%) | 15 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 0/35 (0%) | 0 | 6/19 (31.6%) | 16 |
| BLOOD ALKALINE PHOSPHATASE INCREASED | 3/35 (8.6%) | 8 | 3/19 (15.8%) | 6 |
| BLOOD CHLORIDE DECREASED | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| BLOOD CREATININE INCREASED | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| BLOOD LACTATE DEHYDROGENASE INCREASED | 4/35 (11.4%) | 4 | 0/19 (0%) | 0 |
| HAEMOGLOBIN DECREASED | 1/35 (2.9%) | 1 | 2/19 (10.5%) | 4 |
| WEIGHT DECREASED | 7/35 (20%) | 8 | 2/19 (10.5%) | 2 |
| Metabolism and nutrition disorders | ||||
| ACIDOSIS | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| DECREASED APPETITE | 22/35 (62.9%) | 29 | 10/19 (52.6%) | 10 |
| DEHYDRATION | 2/35 (5.7%) | 2 | 2/19 (10.5%) | 3 |
| DIABETES MELLITUS | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| HYPERCALCAEMIA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| HYPERGLYCAEMIA | 0/35 (0%) | 0 | 1/19 (5.3%) | 3 |
| HYPERKALAEMIA | 2/35 (5.7%) | 3 | 1/19 (5.3%) | 2 |
| HYPOKALAEMIA | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 1 |
| HYPOMAGNESAEMIA | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| HYPONATRAEMIA | 7/35 (20%) | 12 | 6/19 (31.6%) | 10 |
| Musculoskeletal and connective tissue disorders | ||||
| ARTHRALGIA | 8/35 (22.9%) | 14 | 5/19 (26.3%) | 12 |
| BACK PAIN | 5/35 (14.3%) | 6 | 4/19 (21.1%) | 4 |
| MUSCLE SPASMS | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 1 |
| MUSCULAR WEAKNESS | 2/35 (5.7%) | 2 | 4/19 (21.1%) | 4 |
| MUSCULOSKELETAL CHEST PAIN | 1/35 (2.9%) | 1 | 2/19 (10.5%) | 2 |
| MUSCULOSKELETAL PAIN | 2/35 (5.7%) | 3 | 2/19 (10.5%) | 3 |
| MYALGIA | 6/35 (17.1%) | 9 | 5/19 (26.3%) | 12 |
| NECK PAIN | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| PAIN IN EXTREMITY | 10/35 (28.6%) | 14 | 2/19 (10.5%) | 2 |
| PAIN IN JAW | 2/35 (5.7%) | 2 | 4/19 (21.1%) | 4 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| MELANOCYTIC NAEVUS | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| Nervous system disorders | ||||
| DIZZINESS | 2/35 (5.7%) | 2 | 3/19 (15.8%) | 3 |
| DYSARTHRIA | 4/35 (11.4%) | 4 | 0/19 (0%) | 0 |
| DYSGEUSIA | 4/35 (11.4%) | 4 | 0/19 (0%) | 0 |
| HEADACHE | 13/35 (37.1%) | 14 | 6/19 (31.6%) | 9 |
| HYPERAESTHESIA | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| HYPOAESTHESIA | 0/35 (0%) | 0 | 3/19 (15.8%) | 4 |
| HYPOREFLEXIA | 0/35 (0%) | 0 | 5/19 (26.3%) | 10 |
| NEURALGIA | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 3 |
| NEUROPATHY PERIPHERAL | 15/35 (42.9%) | 28 | 1/19 (5.3%) | 3 |
| PARAESTHESIA | 8/35 (22.9%) | 13 | 9/19 (47.4%) | 19 |
| PERIPHERAL MOTOR NEUROPATHY | 8/35 (22.9%) | 17 | 5/19 (26.3%) | 8 |
| PERIPHERAL SENSORY NEUROPATHY | 11/35 (31.4%) | 19 | 9/19 (47.4%) | 23 |
| Psychiatric disorders | ||||
| ANXIETY | 3/35 (8.6%) | 4 | 2/19 (10.5%) | 4 |
| CONFUSIONAL STATE | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| DEPRESSED MOOD | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| DEPRESSION | 2/35 (5.7%) | 3 | 0/19 (0%) | 0 |
| INSOMNIA | 9/35 (25.7%) | 10 | 6/19 (31.6%) | 6 |
| MOOD ALTERED | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 1 |
| Renal and urinary disorders | ||||
| HAEMATURIA | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| COUGH | 2/35 (5.7%) | 2 | 1/19 (5.3%) | 1 |
| DYSPHONIA | 3/35 (8.6%) | 3 | 2/19 (10.5%) | 4 |
| DYSPNOEA | 13/35 (37.1%) | 18 | 4/19 (21.1%) | 6 |
| DYSPNOEA EXERTIONAL | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| EPISTAXIS | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| OROPHARYNGEAL PAIN | 5/35 (14.3%) | 5 | 1/19 (5.3%) | 1 |
| PAINFUL RESPIRATION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| PLEURAL EFFUSION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| VOCAL CORD ATROPHY | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| ALOPECIA | 15/35 (42.9%) | 15 | 1/19 (5.3%) | 2 |
| BLISTER | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
| COLD SWEAT | 1/35 (2.9%) | 1 | 1/19 (5.3%) | 1 |
| DERMATITIS | 0/35 (0%) | 0 | 1/19 (5.3%) | 3 |
| ERYTHEMA | 0/35 (0%) | 0 | 2/19 (10.5%) | 2 |
| NIGHT SWEATS | 2/35 (5.7%) | 2 | 0/19 (0%) | 0 |
| PRURITUS | 10/35 (28.6%) | 12 | 1/19 (5.3%) | 2 |
| RASH | 9/35 (25.7%) | 15 | 2/19 (10.5%) | 4 |
| Vascular disorders | ||||
| HOT FLUSH | 3/35 (8.6%) | 3 | 1/19 (5.3%) | 1 |
| HYPERTENSION | 2/35 (5.7%) | 2 | 2/19 (10.5%) | 2 |
| HYPOTENSION | 0/35 (0%) | 0 | 2/19 (10.5%) | 2 |
| VASOCONSTRICTION | 0/35 (0%) | 0 | 1/19 (5.3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Gajanan Bhat, PhD |
|---|---|
| Organization | Spectrum Pharmaceuticals |
| Phone | 949-743-9219 |
| Gajanan.Bhat@appirx.com |
Responsible Party:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00506142
Other Study ID Numbers:
- HBS408 (formerly IST401)
First Posted:
Jul 25, 2007
Last Update Posted:
Dec 11, 2019
Last Verified:
Nov 1, 2019