Trial Outcomes & Findings for Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer (NCT NCT02139358)
NCT ID: NCT02139358
Last Updated: 2021-02-04
Results Overview
The RP2D dose in mg/m\^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6 Months
Results posted on
2021-02-04
Participant Flow
Participants were enrolled at Moffitt Cancer Center October 2014 through October 2016.
Participant milestones
| Measure |
Dose Escalation / Phase II Treatment
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
Gemcitabine: The Phase I trial will start at the recommended phase II dose (RP2D) for gemcitabine but will have a de-escalation dose levels in the event that an unacceptable toxicity requires dose reduction. Dose level 0 = gemcitabine (1200mg/m2) IV D1,8 q21 days; Dose level -1 = gemcitabine (1000 mg/m\^2) IV D1,8 q21 days; Dose level -2 = gemcitabine (850 mg/m\^2) IV D1,8 q21 days. The RP2D will be the dose level where 0-1 dose limiting toxicities (DLTs) in six patients occur.
Trastuzumab: Trastuzumab will be given using an 8 mg/kg loading dose on cycle one, day one (C1D1), followed by 6 mg/kg IV on subsequent cycles every (q) 21 days.
Pertuzumab: Pertuzumab will be given using an 840 mg IV loading dose on C1D1, followed by 420 mg IV on subsequent cycles q21 days.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Dose Escalation / Phase II Treatment
n=15 Participants
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Age, Continuous
|
58.2 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: All participants enrolled during Phase 1
The RP2D dose in mg/m\^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.
Outcome measures
| Measure |
Dose Escalation / Phase II Treatment
n=6 Participants
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Phase I: Recommended Phase II Dose (RP2D)
|
1200 dose in mg/m^2
|
PRIMARY outcome
Timeframe: Up to 36 MonthsPopulation: All participants who have undergone 2 treatment cycles followed by a response scan and have documented best response data available.
Objective Response Rate: Response according to Response Evaluation in Solid Tumors (RECIST) 1.1 for the combination of gemcitabine+trastuzumab+pertuzumab at the recommended phase II dose. Complete Response (CR): Disappearance of all evidence of tumor for at least two cycles of therapy. Tumor markers must be normal. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking a reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dose Escalation / Phase II Treatment
n=10 Participants
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Phase II: Objective Response Rate (ORR)
Complete Response
|
1 Participants
|
|
Phase II: Objective Response Rate (ORR)
Partial Response
|
1 Participants
|
|
Phase II: Objective Response Rate (ORR)
Stable Disease
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All participants
Median progression free survival (in months) for all participants evaluable for response. The time-to-event data will be summarized using Kaplan-Meir curve method for all patients who are evaluable for the ORR endpoint. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dose Escalation / Phase II Treatment
n=15 Participants
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Phase II: Progression Free Survival (PFS)
|
6.4883 months
Interval 2.7807 to 9.0372
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: All participants
Median overall survival (in months) for all participants evaluable for response. The length of time from the start of treatment that participants are still alive.
Outcome measures
| Measure |
Dose Escalation / Phase II Treatment
n=15 Participants
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Overall Survival (OS)
|
11.3545 months
Interval 6.2897 to 14.0028
|
Adverse Events
Dose Escalation / Phase II Treatment
Serious events: 7 serious events
Other events: 15 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Dose Escalation / Phase II Treatment
n=15 participants at risk
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Cardiac disorders
Chest pain - cardiac
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
General disorders
Sudden death NOS
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 2 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Pneumonia
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
Other adverse events
| Measure |
Dose Escalation / Phase II Treatment
n=15 participants at risk
Single arm, non-randomized, open label phase I/II multisite Simon two stage minimax trial. Gemcitabine plus trastuzumab and pertuzumab.
|
|---|---|
|
Investigations
Neutrophil count decreased
|
80.0%
12/15 • Number of events 47 • 3 years, 7 months
|
|
Investigations
Lymphocyte count decreased
|
66.7%
10/15 • Number of events 19 • 3 years, 7 months
|
|
Investigations
Platelet count decreased
|
60.0%
9/15 • Number of events 24 • 3 years, 7 months
|
|
Investigations
White blood cell decreased
|
60.0%
9/15 • Number of events 48 • 3 years, 7 months
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
6/15 • Number of events 12 • 3 years, 7 months
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
6/15 • Number of events 17 • 3 years, 7 months
|
|
Investigations
Alkaline phosphatase increased
|
13.3%
2/15 • Number of events 3 • 3 years, 7 months
|
|
Investigations
Creatinine increased
|
6.7%
1/15 • Number of events 2 • 3 years, 7 months
|
|
Investigations
Ejection fraction decreased
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
10/15 • Number of events 13 • 3 years, 7 months
|
|
Gastrointestinal disorders
Nausea
|
60.0%
9/15 • Number of events 11 • 3 years, 7 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Number of events 6 • 3 years, 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Gastrointestinal disorders
Dysphagia
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Mucositis oral
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Gastrointestinal disorders
Oral pain
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
General disorders
Fatigue
|
66.7%
10/15 • Number of events 12 • 3 years, 7 months
|
|
General disorders
Infusion related reaction
|
20.0%
3/15 • Number of events 3 • 3 years, 7 months
|
|
General disorders
Pain
|
20.0%
3/15 • Number of events 4 • 3 years, 7 months
|
|
General disorders
Edema limbs
|
13.3%
2/15 • Number of events 3 • 3 years, 7 months
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
General disorders
Malaise
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
6/15 • Number of events 7 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
6/15 • Number of events 8 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
5/15 • Number of events 8 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
5/15 • Number of events 10 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Blood and lymphatic system disorders
Anemia
|
73.3%
11/15 • Number of events 39 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
6/15 • Number of events 8 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
2/15 • Number of events 4 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
6/15 • Number of events 7 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.7%
4/15 • Number of events 6 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
3/15 • Number of events 3 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 3 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Right wrist swelling
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 4 • 3 years, 7 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
3/15 • Number of events 3 • 3 years, 7 months
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Nervous system disorders
Somnolence
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Nervous system disorders
Dysphasia
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
3/15 • Number of events 4 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Left chest wall - Abnormal sensation
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Infections and infestations
Skin infection
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Infections and infestations
Papulopustular rash
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • Number of events 2 • 3 years, 7 months
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
3/15 • Number of events 5 • 3 years, 7 months
|
|
Cardiac disorders
Chest pain - cardiac
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Vascular disorders
Hot flashes
|
13.3%
2/15 • Number of events 2 • 3 years, 7 months
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.7%
1/15 • Number of events 2 • 3 years, 7 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Renal and urinary disorders
Hematuria
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Renal and urinary disorders
Urinary frequency
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Renal and urinary disorders
Urinary tract pain
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Psychiatric disorders
Restlessness
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Reproductive system and breast disorders
Vaginal pain
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Eye disorders
Blurred vision
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Eye disorders
Dry eye
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Cervical polyp
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified and polyps) - Other, Goiter with thyroid modules
|
6.7%
1/15 • Number of events 1 • 3 years, 7 months
|
Additional Information
Dr. Hatem Soliman
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