Trial Outcomes & Findings for Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer (NCT NCT01042535)

Last Updated: 2018-04-11

Results Overview

MTD of 1-methyl-d-tryptophan (indoximod) given by mouth (PO), twice a day (BID), with up to 6 fixed doses Ad.p53 DC vaccinations every 2 weeks (q2wks). This phase 1 study used a 3+3 design with 7 indoximod dose levels (DL) (100 mg, 200 mg, 400 mg, 800 mg daily (QD) then 800 mg, 1,200 mg, and 1,600 mg PO BID +up to 6 fixed dose Ad.p53 DC vaccinations q2wks. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. The MTD is the highest dose level below the maximally administered dose (MAD) that is safely tolerated among 6 treated patients, that is, 0 or 1 out of 6 patients experiences a dose limiting toxicity (DLT).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2018-04-11

Participant Flow

Participants were recruited at Moffitt Cancer Center from December 28, 2009, through February 11, 2014.

Participant milestones

Participant milestones
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Overall Study STARTED	44
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Overall Study disease progression prior to treatment	3
Overall Study disease progression during treatment	3
Overall Study complications from other disease	2

Baseline Characteristics

Vaccine Therapy and 1-MT in Treating Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=44 Participants Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	52.68 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=30 Participants Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Phase 1 - Maximum Tolerated Dose (MTD) in Milligrams (mg)	1600 indoximod dose in mg

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: All evaluable participants at time of analysis

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

Outcome measures
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=21 Participants Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Phase 2 - Number of Participants With Stable Disease In Response to Study Therapy	4 participants

SECONDARY outcome

Timeframe: At 6 weeks

Population: Phase I Participants who Received at Least 1 Dose of Ad.p53DC+indoximod

Immunologic Response defined as Interferon-γ (IFN-γ) p53 T cell specific enzyme-linked immunospot (ELISPOT) assay count Summarized using both point estimates and the 95% exact confidence intervals based on the binomial distribution. Briefly, 2x10\^5 mononuclear cells obtained from the peripheral blood of patients will be plated in quadruplicates in 96-well multiscreen mixed cellulose ester (HA) filtration plates, processed and incubated, spots will be visualized. The number of spots will be calculated per 10\^6 cells. Untreated peripheral blood mononuclear cells (PBMNC) will represent a negative control and PBMNC stimulated with 10 µg/ml Concanavalin A (ConA) - positive control.

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=30 Participants Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Phase 1 - Number of Participants With Objective Response at 6 Weeks	0 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All evaluable participants at time of analysis

Clinical response rate evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD. 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

Outcome measures
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=21 Participants Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Phase 2 - Number of Participants With Clinical Benefit From Chemotherapy After Vaccination Complete Response (CR)	1 participants
Phase 2 - Number of Participants With Clinical Benefit From Chemotherapy After Vaccination Partial Response (PR)	7 participants
Phase 2 - Number of Participants With Clinical Benefit From Chemotherapy After Vaccination Stable Disease (SD)	2 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All evaluable participants at time of analysis

Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PFS: Time from study entry to documentation of radiologic progressive disease or death, assessed up to 3 years.

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=21 Participants Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Phase 2 - Median Progression Free Survival (PFS) in Weeks	6.85 weeks Interval 3.8 to 18.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to week 16

Biomarkers include serum kynurenine, serum tryptophan, C reactive protein, and circulating T-regulatory cell levels (CD4+ 25+ CD127low forkhead box protein 3+ (FoxP3+). Appropriate t-tests and/or Wilcoxon test will be employed to study changes over time.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)

Serious events: 14 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=41 participants at risk Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Anemia	2.4% 1/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Blood and lymphatic system disorders Febrile neutropenia	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Eye disorders Eye disorders - Other, Visual disturbance	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Abdominal pain	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Constipation	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Nausea	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
General disorders Fever	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
General disorders Pain	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Infections and infestations Skin infection	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Alkaline phosphatase increased	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Aspartate aminotransferase increased	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Blood bilirubin increased	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Platelet count decreased	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Bone pain	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign - Other, Disease progression	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Nervous system disorders Nervous system disorder - Other, Disease progression	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Renal and urinary disorders Acute kidney injury	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Vascular disorders Hypotension	2.4% 1/41 • Number of events 1 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.

Other adverse events

Other adverse events
Measure	Treatment (Vaccine Therapy, 1-methyl-d-tryptophan) n=41 participants at risk Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity. adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID) 1-methyl-d-tryptophan: Given orally (PO) Laboratory biomarker analysis: Correlative studies
General disorders Fatigue	65.9% 27/41 • Number of events 39 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
General disorders Edema limbs	12.2% 5/41 • Number of events 5 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
General disorders Fever	7.3% 3/41 • Number of events 4 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
General disorders Flu like symptoms	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
General disorders Pain	4.9% 2/41 • Number of events 3 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Anorexia	34.1% 14/41 • Number of events 16 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hyperglycemia	31.7% 13/41 • Number of events 20 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	24.4% 10/41 • Number of events 14 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hyponatremia	17.1% 7/41 • Number of events 9 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Dehydration	9.8% 4/41 • Number of events 4 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hyperkalemia	7.3% 3/41 • Number of events 4 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hypocalcemia	7.3% 3/41 • Number of events 4 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hypokalemia	7.3% 3/41 • Number of events 4 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Metabolism and nutrition disorders Hypoglycemia	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Alkaline phosphatase increased	34.1% 14/41 • Number of events 20 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Aspartate aminotransferase increased	29.3% 12/41 • Number of events 19 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Lymphocyte count decreased	26.8% 11/41 • Number of events 16 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Alanine aminotransferase increased	19.5% 8/41 • Number of events 11 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations White blood cell decreased	19.5% 8/41 • Number of events 10 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Neutrophil count decreased	12.2% 5/41 • Number of events 5 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Platelet count decreased	7.3% 3/41 • Number of events 5 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Investigations Creatinine increased	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Nausea	36.6% 15/41 • Number of events 17 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Constipation	22.0% 9/41 • Number of events 10 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Vomiting	24.4% 10/41 • Number of events 13 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Abdominal pain	19.5% 8/41 • Number of events 8 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Diarrhea	17.1% 7/41 • Number of events 7 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Dry mouth	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Dyspepsia	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Gastrointestinal disorders Toothache	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Back pain	17.1% 7/41 • Number of events 9 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Bone pain	14.6% 6/41 • Number of events 8 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	9.8% 4/41 • Number of events 5 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	7.3% 3/41 • Number of events 3 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Arthralgia	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Musculoskeletal and connective tissue disorders Flank pain	4.9% 2/41 • Number of events 3 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Blood and lymphatic system disorders Anemia	36.6% 15/41 • Number of events 32 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Blood and lymphatic system disorders Hemolysis	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	24.4% 10/41 • Number of events 12 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.6% 6/41 • Number of events 7 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Nervous system disorders Headache	19.5% 8/41 • Number of events 8 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Nervous system disorders Peripheral sensory neuropathy	17.1% 7/41 • Number of events 9 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Skin and subcutaneous tissue disorders Alopecia	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Infections and infestations Urinary tract infection	7.3% 3/41 • Number of events 3 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Vascular disorders Hypotension	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.
Reproductive system and breast disorders Breast pain	4.9% 2/41 • Number of events 2 • 4 years, 3 months Only 41 of 44 enrolled were at risk. 3 participants had disease progression prior to treatment.

Additional Information

Hatem Soliman, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-4933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place