Trial Outcomes & Findings for Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer (NCT NCT04205903)
NCT ID: NCT04205903
Last Updated: 2025-06-29
Results Overview
Will be classified and attributed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)5.0 and will be summarized within and across dose levels using descriptive statistics. The overall number and percentage of patients experiencing adverse events (AEs) and toxicities will be summarized and reported as across all event types, non-hematologic AEs, hematologic AEs, and for each type. Specific focus will be in summarizing any neuropathy-related AEs by dose level and how this corresponds to our measures of OATP1B1 inhibition. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2025-06-29
Participant Flow
Eleven participants enrolled in the study. One participant withdrew prior to be randomized to a dose level,, leaving ten participants who were randomized to the three dose levels.
Participant milestones
| Measure |
Dose Level 1 (100mg Nilotinib)
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 2 (200mg Nilotinib)
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 3 (300mg Nilotinib)
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nilotinib in Preventing Paclitaxel-Induced Peripheral Neuropathy in Patients With Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1 (100mg Nilotinib)
n=5 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 2 (200mg Nilotinib)
n=3 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 3 (300mg Nilotinib)
n=2 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksWill be classified and attributed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v)5.0 and will be summarized within and across dose levels using descriptive statistics. The overall number and percentage of patients experiencing adverse events (AEs) and toxicities will be summarized and reported as across all event types, non-hematologic AEs, hematologic AEs, and for each type. Specific focus will be in summarizing any neuropathy-related AEs by dose level and how this corresponds to our measures of OATP1B1 inhibition. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.
Outcome measures
| Measure |
Dose Level 1 (100mg Nilotinib)
n=5 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 2 (200mg Nilotinib)
n=3 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 3 (300mg Nilotinib)
n=2 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Number of Adverse Events (Phase Ib)
Sleep apnea
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Vomiting
|
0 Number of Events
|
0 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Anemia
|
10 Number of Events
|
2 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Localized edema
|
3 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Otitis externa
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Anorexia
|
4 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Bone pain
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Insomnia
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Neuralgia
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Dry skin
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Pruritus
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Abdominal pain
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Breast infection
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Muscle cramp
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Peripheral sensory neuropathy
|
5 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Tinnitus
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Aspartate aminotransferase increased Aspartate aminotransferase increased
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Lymphocyte count decreased
|
2 Number of Events
|
1 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Neutrophil count decreased
|
5 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
White blood cell decreased
|
4 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Hyperglycemia
|
3 Number of Events
|
3 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Hyperphosphatemia
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Arthralgia
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Watering eyes
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Constipation
|
1 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Diarrhea
|
4 Number of Events
|
0 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Weight loss
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Musculoskeletal and connective tissue disorder - Other, specify
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Myalgia
|
3 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Dysgeusia
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Headache
|
4 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Nervous system disorders - Other, specify
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Paresthesia
|
1 Number of Events
|
1 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Anxiety
|
1 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Depression
|
3 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Allergic rhinitis
|
4 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Dyspnea
|
2 Number of Events
|
1 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Alopecia
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Bullous dermatitis
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Nail changes
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Pain of skin
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Palmar-plantar erythrodysesthesia syndrome
|
2 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Rash maculo-papular
|
1 Number of Events
|
0 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Skin and subcutaneous tissue disorders - Other, specify
|
5 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Flushing
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Hot flashes
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Hypertension
|
1 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Cardiac disorders - Other, specify
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Ear and labyrinth disorders - Other, specify
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Dry mouth
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Blurred vision
|
1 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Alanine aminotransferase increased
|
0 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Eye pain
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Gastroesophageal reflux disease
|
2 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Gastrointestinal disorders - Other, specify
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Mucositis oral
|
4 Number of Events
|
1 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Hypokalemia
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Nausea
|
3 Number of Events
|
2 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Edema limbs
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Fatigue
|
4 Number of Events
|
2 Number of Events
|
3 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Pain
|
1 Number of Events
|
2 Number of Events
|
4 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Dizziness
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Mucosal infection
|
2 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Injury, poisoning and procedural complications - Other, specify
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Alkaline phosphatase increased
|
1 Number of Events
|
0 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Peripheral motor neuropathy
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Dysuria
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Skin hyperpigmentation
|
0 Number of Events
|
1 Number of Events
|
0 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Platelet count decreased
|
0 Number of Events
|
0 Number of Events
|
2 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Back pain
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Joint range of motion decreased
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Scoliosis
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
|
Number of Adverse Events (Phase Ib)
Extrapyramidal disorder
|
0 Number of Events
|
0 Number of Events
|
1 Number of Events
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: The 6 participants who completed study treatment were evaluated for this outcome.
The RP2D will be derived from an adaptive Bayesian method for dose-finding based on trade-offs between the probabilities of treatment efficacy and toxicity. In this design, treatment efficacy is defined as significant inhibition of OATP1B1 activity by nilotinib, without causing changes in the pharmacokinetic profiles of paclitaxel. Efficacy in this setting will be OATP1B1 inhibition as defined by a \>= 5-fold increase in the area under the curve (AUC) of GCDCA-S from pre- to post-treatment and/or detectable CDCA-24G levels post-treatment.
Outcome measures
| Measure |
Dose Level 1 (100mg Nilotinib)
n=6 Participants
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 2 (200mg Nilotinib)
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 3 (300mg Nilotinib)
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Recommended Phase II Dose (RP2D) of Nilotinib in Combination With Paclitaxel (Phase Ib)
|
NA milligrams
A recommended phase 2 dose was not determined as none of the dose level cohorts reached the efficacy threshold.
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: : Pre-dose, prior to starting paclitaxel (day 1, day 8), prior to starting nilotinib (day 8 only), immediately prior to end of paclitaxel, after paclitaxel on days 1 and 8 and pre-dose, after nilotinib on day 7.Will explore PK endpoints Area under the plasma concentration versus time curve (AUC)
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=5 participants at risk
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 2
n=3 participants at risk
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 3
n=2 participants at risk
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
Other adverse events
| Measure |
Dose Level 1
n=5 participants at risk
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 2
n=3 participants at risk
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
Dose Level 3
n=2 participants at risk
Patients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nilotinib hydrochloride monohydrate PO on days 7, 8, 14, and 15 of cycle 1 and days -1, 1, 7, 8, 14, and 15 of cycle 2. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Nilotinib: Given PO
Nilotinib Hydrochloride Monohydrate: Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
Paclitaxel: Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
2/5 • Number of events 10 • Up to 6 weeks
|
33.3%
1/3 • Number of events 2 • Up to 6 weeks
|
100.0%
2/2 • Number of events 2 • Up to 6 weeks
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Eye disorders
Blurred vision
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Eye disorders
Eye pain
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Eye disorders
Watering eyes
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 4 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
100.0%
2/2 • Number of events 4 • Up to 6 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Number of events 2 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
60.0%
3/5 • Number of events 4 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 3 • Up to 6 weeks
|
66.7%
2/3 • Number of events 2 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
General disorders
Edema limbs
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 4 • Up to 6 weeks
|
66.7%
2/3 • Number of events 2 • Up to 6 weeks
|
100.0%
2/2 • Number of events 3 • Up to 6 weeks
|
|
General disorders
Localized edema
|
40.0%
2/5 • Number of events 3 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
General disorders
Pain
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
66.7%
2/3 • Number of events 2 • Up to 6 weeks
|
100.0%
2/2 • Number of events 4 • Up to 6 weeks
|
|
Infections and infestations
Mucosal infection
|
20.0%
1/5 • Number of events 2 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Infections and infestations
Otitis externa
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 2 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
100.0%
2/2 • Number of events 3 • Up to 6 weeks
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 4 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
100.0%
2/2 • Number of events 2 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 4 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 3 • Up to 6 weeks
|
66.7%
2/3 • Number of events 3 • Up to 6 weeks
|
100.0%
2/2 • Number of events 2 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
2/5 • Number of events 3 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 2 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 4 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Nervous system disorders
Paresthesia
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 4 • Up to 6 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
80.0%
4/5 • Number of events 5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Psychiatric disorders
Depression
|
40.0%
2/5 • Number of events 3 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
20.0%
1/5 • Number of events 4 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
2/5 • Number of events 2 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
100.0%
2/2 • Number of events 3 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
1/5 • Number of events 2 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
100.0%
2/2 • Number of events 3 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
40.0%
2/5 • Number of events 5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Vascular disorders
Hot flashes
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Investigations
Weight loss
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • Up to 6 weeks
|
33.3%
1/3 • Number of events 1 • Up to 6 weeks
|
0.00%
0/2 • Up to 6 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 4 • Up to 6 weeks
|
|
Infections and infestations
Breast infection
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 2 • Up to 6 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 2 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/5 • Up to 6 weeks
|
0.00%
0/3 • Up to 6 weeks
|
50.0%
1/2 • Number of events 1 • Up to 6 weeks
|
Additional Information
Dr. Nicole Williams
The Ohio State University Comprehensive Cancer Center
Phone: (614) 293-0066
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place