Trial Outcomes & Findings for Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer (NCT NCT00526799)
NCT ID: NCT00526799
Last Updated: 2016-03-03
Results Overview
An initial 3 patients will be enrolled at dose level 1. If all 3 patients in dose level 1 complete the first cycle of therapy without a dose limiting toxicity (DLT), 3 patients will be enrolled at dose level 2. If 0 of 3 or 1 of 6 patients in dose level 2 experience a DLT, all subsequent patients will be enrolled in the Phase II cohort at dose level 2. If 2 of the first 3 or 2 of the total 6 patients experience DLT at dose level 2, then dose level 1 will be considered the MTD and used in the second phase.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.
Results posted on
2016-03-03
Participant Flow
Participant milestones
| Measure |
Phase I
Topotecan 3.5 mg/m\^2 + Sorafenib assigned dose level:
Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid
|
Phase II
Topotecan 3.5 mg/m\^2 + Sorafenib 400 mg po daily.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Phase I
Topotecan 3.5 mg/m\^2 + Sorafenib assigned dose level:
Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid
|
Phase II
Topotecan 3.5 mg/m\^2 + Sorafenib 400 mg po daily.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Intercurrent Complicating Disease
|
0
|
1
|
Baseline Characteristics
Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Phase I
n=16 Participants
Topotecan 3.5 mg/m\^2 + Sorafenib assigned dose level:
Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid
|
Phase II
n=14 Participants
Topotecan 3.5 mg/m\^2 + Sorafenib 400 mg po daily.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.5 years
n=5 Participants
|
52.5 years
n=7 Participants
|
52.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Eastern Cooperative Onocology Group (ECOG) Perfomance Status
ECOG=0
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Eastern Cooperative Onocology Group (ECOG) Perfomance Status
ECOG=1
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Origin of Cancer
Epithelial Ovarian Cancer
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Origin of Cancer
Primary Peritoneal Carcinomatosis
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Histology
Serous Papillary
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Histology
Clear Cell
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Histology
Endometroid
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Histology
Other
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Number of Prior Therapies
|
2 Prior Therapies
n=5 Participants
|
3 Prior Therapies
n=7 Participants
|
2 Prior Therapies
n=5 Participants
|
|
Response Evaluation
Measurable Disease (RECIST)
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Response Evaluation
Detectable Disease
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Platinum Sensitivity
Platinum refractory
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Platinum Sensitivity
Platinum Resistant
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Platinum Sensitivity
Platinum allergy
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
CA125 at Enrollment
|
744.2 U/mL
n=5 Participants
|
1669.0 U/mL
n=7 Participants
|
744.2 U/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Each participant was treated at their assigned dose level on 28 day cycles until disease progression or unacceptable toxicity. Participants were evaluated for toxicity every two weeks.Population: Of the 16 patients enrolled in the phase I study, five were not evaluable for MTD determination due to intercurrent illnesses interfering with toxicity assessment or withdrawal and were replaced or excluded.
An initial 3 patients will be enrolled at dose level 1. If all 3 patients in dose level 1 complete the first cycle of therapy without a dose limiting toxicity (DLT), 3 patients will be enrolled at dose level 2. If 0 of 3 or 1 of 6 patients in dose level 2 experience a DLT, all subsequent patients will be enrolled in the Phase II cohort at dose level 2. If 2 of the first 3 or 2 of the total 6 patients experience DLT at dose level 2, then dose level 1 will be considered the MTD and used in the second phase.
Outcome measures
| Measure |
Phase I Participants
n=11 Participants
Phase I Participants evaluable for MTD
|
|---|---|
|
Maximum Tolerated Dose (MTD)
|
400 mg/day
|
PRIMARY outcome
Timeframe: Disease assessments were conducted on the 8th week (Cycle 2, Week 4) and every eight weeks there after, until treatment discontinuationTo assess response in patients with recurrent or resistant epithelial ovarian cancer treated with Sorafenib plus Topotecan. Reponse evaluated per RECIST criteria where: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Phase I Participants
n=14 Participants
Phase I Participants evaluable for MTD
|
|---|---|
|
Percentage of Participants With Response
partial reponse
|
7.1 percentage of participants
|
|
Percentage of Participants With Response
stable disease
|
71.4 percentage of participants
|
|
Percentage of Participants With Response
progressive disease
|
14.3 percentage of participants
|
|
Percentage of Participants With Response
unevaluable
|
7.1 percentage of participants
|
|
Percentage of Participants With Response
complete response
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From enrollment until treatment discontinuation. Participants may remain on study drug indefinitelyTo determine the progression-free survival of patients treated with Sorafenib plus Topotecan.
Outcome measures
| Measure |
Phase I Participants
n=30 Participants
Phase I Participants evaluable for MTD
|
|---|---|
|
Progression-free Survival
|
3.7 months
Interval 3.0 to 5.5
|
SECONDARY outcome
Timeframe: From enrollment until treatment discontinuation. Participants may remain on study drug indefinitelyTo determine the rate of clinical benefit defined as the percentage of patients experiencing an objective response or a CA125 response.
Outcome measures
| Measure |
Phase I Participants
n=14 Participants
Phase I Participants evaluable for MTD
|
|---|---|
|
Clinical Benefit
|
71.4 percentage of particpants
Interval 41.9 to 91.6
|
SECONDARY outcome
Timeframe: From enrollment until treatment discontinuation. Participants may remain on study drug indefinitelyTo determine duration of stable disease, in months
Outcome measures
| Measure |
Phase I Participants
n=14 Participants
Phase I Participants evaluable for MTD
|
|---|---|
|
Duration of Stable Disease
|
4.2 months
Interval 3.4 to 5.5
|
Adverse Events
Phase I/Phase II
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I/Phase II
n=30 participants at risk
All Phase I/Phase II participants
|
|---|---|
|
Investigations
ALKALINE PHOSPHATASE
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
OBSTRUCTION, GI / SMALL BOWEL NOS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
Other adverse events
| Measure |
Phase I/Phase II
n=30 participants at risk
All Phase I/Phase II participants
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
10.0%
3/30 • Number of events 5 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
ALKALINE PHOSPHATASE
|
16.7%
5/30 • Number of events 5 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
6.7%
2/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
ANOREXIA
|
20.0%
6/30 • Number of events 14 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)
|
6.7%
2/30 • Number of events 10 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
13.3%
4/30 • Number of events 4 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Ear and labyrinth disorders
AUDITORY/EAR - OTHER (SPECIFY, __)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
16.7%
5/30 • Number of events 8 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Nervous system disorders
CONFUSION
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
CONSTIPATION
|
56.7%
17/30 • Number of events 21 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.7%
2/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
CREATININE
|
6.7%
2/30 • Number of events 3 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
DEHYDRATION
|
10.0%
3/30 • Number of events 8 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
DENTAL: DENTURES OR PROSTHESIS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
3.3%
1/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
DIARRHEA
|
23.3%
7/30 • Number of events 12 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Nervous system disorders
DIZZINESS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Eye disorders
DRY EYE SYNDROME
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
30.0%
9/30 • Number of events 9 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
10.0%
3/30 • Number of events 3 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
53.3%
16/30 • Number of events 31 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
FEBRILE NEUTROPENIA (ANC <1.0 X 10E9/L, FEVER >=38.5 DEGREES C)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
FLUSHING
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
16.7%
5/30 • Number of events 7 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
16.7%
5/30 • Number of events 7 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
56.7%
17/30 • Number of events 43 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
HEMORRHAGE/BLEEDING - OTHER (SPECIFY, __)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / BRONCHUS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / UPPER AIRWAY NOS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / EXTERNAL EAR (OTITIS EXTERNA)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / LUNG (PNEUMONIA)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SOFT TISSUE NOS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / URINARY TRACT NOS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
INSOMNIA
|
40.0%
12/30 • Number of events 19 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
30.0%
9/30 • Number of events 17 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
13.3%
4/30 • Number of events 6 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
16.7%
5/30 • Number of events 6 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
10.0%
3/30 • Number of events 4 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
13.3%
4/30 • Number of events 7 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-UPPER
|
3.3%
1/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
6.7%
2/30 • Number of events 3 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
NAUSEA
|
63.3%
19/30 • Number of events 39 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
40.0%
12/30 • Number of events 12 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
50.0%
15/30 • Number of events 42 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
43.3%
13/30 • Number of events 16 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
PAIN / BACK
|
16.7%
5/30 • Number of events 6 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Renal and urinary disorders
PAIN / BLADDER
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Reproductive system and breast disorders
PAIN / BREAST
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
10.0%
3/30 • Number of events 3 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
13.3%
4/30 • Number of events 10 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
PAIN / FACE
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
PAIN / HEAD/HEADACHE
|
6.7%
2/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
13.3%
4/30 • Number of events 4 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
6.7%
2/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
PAIN / ORAL CAVITY
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
PAIN / PAIN NOS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
PAIN / PELVIS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
3.3%
1/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Blood and lymphatic system disorders
PLATELETS
|
40.0%
12/30 • Number of events 38 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
13.3%
4/30 • Number of events 6 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
PROTEINURIA
|
6.7%
2/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
16.7%
5/30 • Number of events 5 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
3.3%
1/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
20.0%
6/30 • Number of events 6 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
16.7%
5/30 • Number of events 5 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / SINUS TACHYCARDIA
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
6.7%
2/30 • Number of events 2 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Skin and subcutaneous tissue disorders
URTICARIA (HIVES, WELTS, WHEALS)
|
3.3%
1/30 • Number of events 3 • Duration of Study
Combined Phase I/Phase II safety data
|
|
Gastrointestinal disorders
VOMITING
|
30.0%
9/30 • Number of events 20 • Duration of Study
Combined Phase I/Phase II safety data
|
|
General disorders
WEIGHT LOSS
|
3.3%
1/30 • Number of events 1 • Duration of Study
Combined Phase I/Phase II safety data
|
Additional Information
Principal Investigator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place