Trial Outcomes & Findings for Dinaciclib in Treating Patients With Stage IV Melanoma (NCT NCT00937937)
NCT ID: NCT00937937
Last Updated: 2025-09-12
Results Overview
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Weekly, up to 3 years
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
Dinaciclib
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
Dinaciclib
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Progression/relapse
|
61
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Dinaciclib in Treating Patients With Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Dinaciclib
n=72 Participants
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
65.4 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
69 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1 participants
n=93 Participants
|
|
Hispanic
Yes
|
2 participants
n=93 Participants
|
|
Hispanic
No
|
69 participants
n=93 Participants
|
|
Hispanic
Unknown
|
1 participants
n=93 Participants
|
|
Performance Status
0
|
38 participants
n=93 Participants
|
|
Performance Status
1
|
34 participants
n=93 Participants
|
|
Site(s) of Metastases
Bone
|
18 participants
n=93 Participants
|
|
Site(s) of Metastases
Brain
|
0 participants
n=93 Participants
|
|
Site(s) of Metastases
Liver
|
23 participants
n=93 Participants
|
|
Site(s) of Metastases
Lymph node, soft tissue, skin
|
41 participants
n=93 Participants
|
|
Site(s) of Metastases
Lung
|
41 participants
n=93 Participants
|
|
Site(s) of Metastases
Other visceral
|
17 participants
n=93 Participants
|
|
Site(s) of Metastases
Other non-visceral
|
14 participants
n=93 Participants
|
|
Elevated LDH
No
|
41 participants
n=93 Participants
|
|
Elevated LDH
Yes
|
31 participants
n=93 Participants
|
|
Primary Type
Cutaneous
|
55 participants
n=93 Participants
|
|
Primary Type
Mucosal
|
8 participants
n=93 Participants
|
|
Primary Type
Unknown primary
|
9 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Weekly, up to 3 yearsFrom date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Dinaciclib
n=72 Participants
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
8 months
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: Disease assessment was performed every 6 weeks, up to 3 years.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The duration from the date of randomization to the date of first documentation of progressive disease, symptomatic deterioration, or death dure to any cause.
Outcome measures
| Measure |
Dinaciclib
n=72 Participants
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival Assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
|
1.4 months
Interval 1.4 to 1.5
|
SECONDARY outcome
Timeframe: Disease assessments for response were performed every 6 weeks, up to 3 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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.
Outcome measures
| Measure |
Dinaciclib
n=72 Participants
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) Assessed by RECIST
|
0 percentage of participants
Interval 0.0 to 0.05
|
SECONDARY outcome
Timeframe: Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.Population: Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The outcome measure here is different from Serious Adverse Event, whose definition could be more strict and specific. The number of patients who suffers the certain adverse event listed here could be larger than the number listed in following serious adverse event.
Outcome measures
| Measure |
Dinaciclib
n=72 Participants
Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
AST, SGOT
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac troponin I (cTnI)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac-ischemia/infarction
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constitutional Symptoms-Other (Specify)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
11 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea (shortness of breath)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema: limb
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue (asthenia, lethargy, malaise)
|
3 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypoxia
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytes (total WBC)
|
18 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphopenia
|
5 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Metabolic/Laboratory-Other (Specify)
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis/stomatitis (clinical exam) - Oral cavity
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophils/granulocytes (ANC/AGC)
|
36 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ocular/Visual-Other (Specify)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
PTT (Partial thromboplastin time)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Abdomen NOS
|
2 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Back
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Cardiac/heart
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Extremity-limb
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Head/headache
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain - Tumor pain
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Prolonged QTc interval
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal failure
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Atrial flutter
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
SVT and nodal arrhythmia - Sinus tachycardia
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sodium, serum-low (hyponatremia)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Somnolence/depressed level of consciousness
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope (fainting)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thrombosis/thrombus/embolism
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vascular-Other (Specify)
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vision-blurred vision
|
1 Participants
|
|
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
1 Participants
|
Adverse Events
SCH 727965
Serious events: 30 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SCH 727965
n=72 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Cardiac disorders
Pain - Cardiac/heart
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Cardiac disorders
SVT and nodal arrhythmia - Atrial fibrillation
|
2.8%
2/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Eye disorders
Ocular/Visual-Other
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Eye disorders
Vision-blurred vision
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Edema: limb
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Edema: trunk/genital
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Pain - Chest/thorax NOS
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Pain-Other
|
2.8%
2/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
AST, SGOT
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Alkaline phosphatase
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Cardiac troponin I (cTnI)
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Leukocytes (total WBC)
|
2.8%
2/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Lymphopenia
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
18.1%
13/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
3/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.8%
2/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Trismus (diff, restriction, pain opening mouth)
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
2.8%
2/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Neuropathy: motor
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Neuropathy: sensory
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Ocular/Visual-Other
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Pain - Head/headache
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Syncope (fainting)
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
4.2%
3/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Vascular disorders
Hypotension
|
4.2%
3/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Vascular disorders
Vascular-Other
|
1.4%
1/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
Other adverse events
| Measure |
SCH 727965
n=72 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
41.7%
30/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Eye disorders
Vision-blurred vision
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
18/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
59.7%
43/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
6.9%
5/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
58.3%
42/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
13.9%
10/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
30/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Edema: limb
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
62.5%
45/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Fever in absence of neutropenia, ANC lt1.0x10e9/L
|
9.7%
7/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
General disorders
Rigors/chills
|
9.7%
7/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Infections and infestations
Infection-Other
|
6.9%
5/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
12.5%
9/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
AST, SGOT
|
12.5%
9/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Alkaline phosphatase
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Creatinine
|
12.5%
9/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Leukocytes (total WBC)
|
55.6%
40/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Lymphopenia
|
18.1%
13/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Metabolic/Laboratory-Other
|
6.9%
5/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
56.9%
41/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Platelets
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Investigations
Weight loss
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
16.7%
12/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
16/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
5/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
19.4%
14/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.3%
6/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
16.7%
12/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
9.7%
7/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
8.3%
6/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Dizziness
|
6.9%
5/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Neuropathy: sensory
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Pain - Head/headache
|
9.7%
7/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Psychiatric disorders
Mood alteration - depression
|
6.9%
5/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.3%
6/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
16/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.1%
8/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
5.6%
4/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Hair loss/Alopecia (scalp or body)
|
15.3%
11/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.3%
6/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
9.7%
7/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
|
Vascular disorders
Hypotension
|
22.2%
16/72 • Toxicity assessment was evaluated after each cycle (21 days), up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60