Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02115542
Collaborator
Bayer (Industry)
39
3
1
87.5
13
0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers
Actual Study Start Date :
Jun 5, 2014
Actual Primary Completion Date :
Dec 10, 2018
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regorafenib Monotherapy

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Drug: Regorafenib
Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
Other Names:
  • Stivarga
  • BAY73-4506
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) at 6 Months [at 6 month follow-up]

      OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.

    Secondary Outcome Measures

    1. Disease Control Response (DCR) [Post 6 months follow-up, up to 13 months from on treatment per participant]

      DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.

    2. Progression Free Survival (PFS) [Post 6 months follow-up, up to 13 months from on treatment per participant]

      PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease. Patients with ampullary carcinoma are not eligible.

    • Have failed no more than 2 prior lines of systemic chemotherapy for advanced biliary cancer. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If patient received adjuvant treatment and had disease recurrence after 6 months, they will only be eligible after failing one line of systemic chemotherapy used to treat the disease recurrence.

    • Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or 1

    • Measurable and non-measurable disease will be allowed.

    • Must not have been treated with any vascular endothelial growth factor (VEGF) inhibitors. Prior 5-Fluorouracil (5-FU) or capecitabine treatment is allowed only if given as a radiosensitizer concurrently with radiation therapy at least 12 weeks prior to registration or if given as part of any adjuvant therapy regimen > 6 months prior to study enrollment.

    • Life expectancy of at least 12 weeks (3 months)

    • For patients who have received prior cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy (lesions that have not been treated with local therapy must be present and measureable.

    • Able to understand and willing to sign the written informed consent form

    • All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).

    • Adequate bone marrow and liver function

    • Participants can receive 5-FU or capecitabine.

    • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.

    • Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug.

    • Able to swallow and retain oral medication

    Exclusion Criteria:
    • Previous assignment to treatment during this study. Participants permanently withdrawn from study participation will not be allowed to re-enter study.

    • Other investigational treatment during or within 21 days before starting study treatment

    • Child Pugh B and C

    • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management

    • Active or clinically significant cardiac disease

    • Evidence or history of bleeding diathesis or coagulopathy

    • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication

    • Participants with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of informed consent

    • Active malignancy except for nonmelanoma skin cancer or in situ cervical cancer. Potential participants surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before the trial are allowed. All cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form).

    • Potential participants with phaeochromocytoma

    • Potential participants with severe hepatic impairment (Child-Pugh Class C)

    • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.

    • Ongoing infection > Grade 2 NCI-CTCAE v4.0

    • Symptomatic metastatic brain or meningeal tumors

    • Presence of a non-healing wound, non-healing ulcer, or bone fracture

    • Renal failure requiring hemo-or peritoneal dialysis

    • Patients with seizure disorder requiring medication

    • Persistent proteinuria >/= Grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hours, measured by urine protein:creatinine ratio on a random urine sample)

    • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent

    • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 4.0 Grade 2 dyspnea)

    • History of organ allograft (including corneal transplant)

    • Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial

    • Any malabsorption condition

    • Women who are pregnant or breast-feeding

    • Any condition which, in the investigator's opinion, makes the potential participant unsuitable for trial participation

    • Substance abuse, medical, psychological or social conditions that may interfere with participation in the study or evaluation of the study results

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    2 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27514
    3 VCU Massey Cancer Center Richmond Virginia United States 23298

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute
    • Bayer

    Investigators

    • Principal Investigator: Richard Kim, M.D., H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT02115542
    Other Study ID Numbers:
    • MCC-17651
    First Posted:
    Apr 16, 2014
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Sep 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Regorafenib Monotherapy
    Arm/Group Description Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days. Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
    Period Title: Overall Study
    STARTED 39
    COMPLETED 39
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Regorafenib Monotherapy
    Arm/Group Description Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days. Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
    Overall Participants 39
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    24
    61.5%
    >=65 years
    15
    38.5%
    Sex: Female, Male (Count of Participants)
    Female
    24
    61.5%
    Male
    15
    38.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    4
    10.3%
    Not Hispanic or Latino
    35
    89.7%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    1
    2.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    2.6%
    White
    35
    89.7%
    More than one race
    0
    0%
    Unknown or Not Reported
    2
    5.1%
    Region of Enrollment (participants) [Number]
    United States
    39
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival (OS) at 6 Months
    Description OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.
    Time Frame at 6 month follow-up

    Outcome Measure Data

    Analysis Population Description
    Patients that were evaluable for efficacy
    Arm/Group Title Regorafenib Monotherapy
    Arm/Group Description Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days. Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
    Measure Participants 32
    Median (95% Confidence Interval) [months]
    7.9
    2. Secondary Outcome
    Title Disease Control Response (DCR)
    Description DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.
    Time Frame Post 6 months follow-up, up to 13 months from on treatment per participant

    Outcome Measure Data

    Analysis Population Description
    Patients that were evaluable for efficacy
    Arm/Group Title Regorafenib Monotherapy
    Arm/Group Description Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days. Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
    Measure Participants 32
    Number [percentage of patients]
    62.5
    3. Secondary Outcome
    Title Progression Free Survival (PFS)
    Description PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.
    Time Frame Post 6 months follow-up, up to 13 months from on treatment per participant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Regorafenib Monotherapy
    Arm/Group Description Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days. Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
    Measure Participants 32
    Median (95% Confidence Interval) [months]
    2.8

    Adverse Events

    Time Frame From consent to study completion, 3 years 3 months
    Adverse Event Reporting Description
    Arm/Group Title Regorafenib Monotherapy
    Arm/Group Description Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days. Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
    All Cause Mortality
    Regorafenib Monotherapy
    Affected / at Risk (%) # Events
    Total 9/39 (23.1%)
    Serious Adverse Events
    Regorafenib Monotherapy
    Affected / at Risk (%) # Events
    Total 27/39 (69.2%)
    Cardiac disorders
    Myocardial infarction 1/39 (2.6%) 1
    Gastrointestinal disorders
    Gastritis 1/39 (2.6%) 1
    Hiccups 1/39 (2.6%) 1
    Abdominal Pain 5/39 (12.8%) 5
    Nausea 3/39 (7.7%) 3
    Vomiting 2/39 (5.1%) 2
    Gastrointestinal disorders - Other 1/39 (2.6%) 1
    Colitis 1/39 (2.6%) 1
    Constipation 1/39 (2.6%) 1
    Upper gastrointestinal hemorrhage 1/39 (2.6%) 1
    Pancreatitis 1/39 (2.6%) 1
    Bile duct stenosis 1/39 (2.6%) 1
    General disorders
    Death NOS 6/39 (15.4%) 6
    Fatigue 4/39 (10.3%) 4
    Fever 1/39 (2.6%) 1
    Non-cardiac chest pain 1/39 (2.6%) 1
    Multi-organ failure 1/39 (2.6%) 1
    Infections and infestations
    Infections and Infestations - Other 1/39 (2.6%) 1
    Infections and Infestations - Other 1/39 (2.6%) 1
    Blood bilirubin increased 2/39 (5.1%) 2
    Sepsis 1/39 (2.6%) 1
    Urinary tract infection 1/39 (2.6%) 1
    Investigations
    Platelet count decreased 2/39 (5.1%) 2
    Metabolism and nutrition disorders
    Dehydration 2/39 (5.1%) 2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders -Other 1/39 (2.6%) 1
    Nervous system disorders
    Facial nerve disorder 1/39 (2.6%) 1
    Renal and urinary disorders
    Chronic kidney disease 1/39 (2.6%) 1
    Acute kidney injury 2/39 (5.1%) 2
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders - Other 2/39 (5.1%) 2
    Pleural effusion 1/39 (2.6%) 1
    Dyspnea 1/39 (2.6%) 1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 1/39 (2.6%) 1
    Vascular disorders
    Thromboembolic event 1/39 (2.6%) 1
    Other (Not Including Serious) Adverse Events
    Regorafenib Monotherapy
    Affected / at Risk (%) # Events
    Total 39/39 (100%)
    Blood and lymphatic system disorders
    Anemia 12/39 (30.8%) 22
    Leukocytosis 2/39 (5.1%) 3
    Cardiac disorders
    Sinus tachycardia 2/39 (5.1%) 2
    Atrial fibrillation 1/39 (2.6%) 1
    Myocardial infarction 1/39 (2.6%) 1
    Ear and labyrinth disorders
    Ear pain 2/39 (5.1%) 2
    Hearing impaired 1/39 (2.6%) 1
    Endocrine disorders
    Hypothyroidism 1/39 (2.6%) 1
    Eye disorders
    Blurred vision 1/39 (2.6%) 1
    Eye disorders - Other 1/39 (2.6%) 1
    Gastrointestinal disorders
    Abdominal distension 1/39 (2.6%) 1
    Abdominal pain 20/39 (51.3%) 34
    Mucositis oral 17/39 (43.6%) 27
    Constipation 13/39 (33.3%) 13
    Nausea 12/39 (30.8%) 20
    Vomiting 9/39 (23.1%) 16
    Ascites 8/39 (20.5%) 8
    Diarrhea 8/39 (20.5%) 13
    Dry mouth 4/39 (10.3%) 4
    Bloating 2/39 (5.1%) 2
    Gastritis 2/39 (5.1%) 2
    Gastrointestinal disorders - Other 2/39 (5.1%) 3
    Oral dysesthesia 2/39 (5.1%) 2
    Oral pain 2/39 (5.1%) 2
    Colitis 1/39 (2.6%) 1
    Dyspepsia 1/39 (2.6%) 1
    Gastroesophageal reflux disease 1/39 (2.6%) 1
    Gastroparesis 1/39 (2.6%) 1
    Gingival pain 1/39 (2.6%) 1
    Pancreatitis 1/39 (2.6%) 1
    Periodontal disease 1/39 (2.6%) 1
    Proctitis 1/39 (2.6%) 1
    Rectal hemorrhage 1/39 (2.6%) 1
    Upper gastrointestinal hemorrhage 1/39 (2.6%) 1
    General disorders
    Fatigue 25/39 (64.1%) 42
    Fever 10/39 (25.6%) 12
    Pain 8/39 (20.5%) 12
    Chills 4/39 (10.3%) 6
    Non-cardiac chest pain 4/39 (10.3%) 4
    Edema limbs 3/39 (7.7%) 3
    Flu like symptoms 3/39 (7.7%) 3
    General disorders and administration site conditions - other 1/39 (2.6%) 1
    Multi-organ faillure 1/39 (2.6%) 1
    Hepatobiliary disorders
    Bile duct stenosis 1/39 (2.6%) 1
    Infections and infestations
    Urinary tract infection 9/39 (23.1%) 14
    Sepsis 3/39 (7.7%) 3
    Infections and infestations - Other 2/39 (5.1%) 2
    Joint infection 1/39 (2.6%) 1
    Nail infection 1/39 (2.6%) 1
    Sinusitis 1/39 (2.6%) 1
    Skin infection 1/39 (2.6%) 1
    Injury, poisoning and procedural complications
    Ankle fracture 1/39 (2.6%) 1
    Investigations
    Alkaline phosphatase increased 23/39 (59%) 35
    Alkaline aminotransferase increased 21/39 (53.8%) 32
    Aspartate aminotransferase increased 20/39 (51.3%) 33
    Blood bilirubin increased 17/39 (43.6%) 37
    Platelet count decreased 15/39 (38.5%) 32
    Lymphocyte count decreased 14/39 (35.9%) 31
    Weight loss 9/39 (23.1%) 14
    White blood cell decreased 8/39 (20.5%) 15
    Neutrophil count decreased 7/39 (17.9%) 9
    Creatinine increased 2/39 (5.1%) 2
    Activated partial thromboplastin time prolonged 1/39 (2.6%) 1
    Investigations - Other 1/39 (2.6%) 1
    Lipase increased 1/39 (2.6%) 2
    Lymphocyte count increased 1/39 (2.6%) 1
    Metabolism and nutrition disorders
    Hypoalbuminemia 14/39 (35.9%) 22
    Hypophosphatemia 13/39 (33.3%) 22
    Hyponatremia 12/39 (30.8%) 12
    Anorexia 11/39 (28.2%) 16
    Hypocalcemia 9/39 (23.1%) 14
    Dehydration 7/39 (17.9%) 9
    Hyperglycemia 6/39 (15.4%) 9
    Hyperkalemia 6/39 (15.4%) 7
    Hypokalemia 4/39 (10.3%) 6
    Hypermagnesemia 2/39 (5.1%) 2
    Hypercalcemia 1/39 (2.6%) 1
    Hypoglycemia 1/39 (2.6%) 1
    Hypomagnesemia 1/39 (2.6%) 2
    Musculoskeletal and connective tissue disorders
    Back pain 4/39 (10.3%) 5
    Myalgia 4/39 (10.3%) 4
    Neck pain 2/39 (5.1%) 2
    Pain in extremity 2/39 (5.1%) 4
    Arthralgia 1/39 (2.6%) 1
    Generalized muscle weakness 1/39 (2.6%) 1
    Musculoskeletal and connective tissue disorder - Other 1/39 (2.6%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified -Other 1/39 (2.6%) 1
    Nervous system disorders
    Headache 11/39 (28.2%) 15
    Dizziness 4/39 (10.3%) 5
    Dysgeusia 2/39 (5.1%) 2
    Tremor 2/39 (5.1%) 2
    Facial nerve disorder 1/39 (2.6%) 2
    Radiculitis 1/39 (2.6%) 1
    Psychiatric disorders
    Anxiety 2/39 (5.1%) 2
    Confusion 2/39 (5.1%) 2
    Agitation 1/39 (2.6%) 1
    Depression 1/39 (2.6%) 1
    Hallucinations 1/39 (2.6%) 1
    Insomnia 1/39 (2.6%) 1
    Renal and urinary disorders
    Acute kidney injury 1/39 (2.6%) 1
    Chronic kidney disease 1/39 (2.6%) 1
    Cyctitis noninfective 1/39 (2.6%) 1
    Hematuria 1/39 (2.6%) 1
    Proteinuria 1/39 (2.6%) 1
    Renal and urinary disorders - Other 1/39 (2.6%) 1
    Reproductive system and breast disorders
    Reproductive system and breast disorders - Other 1/39 (2.6%) 1
    Vaginal hemorrhage 1/39 (2.6%) 2
    Respiratory, thoracic and mediastinal disorders
    Hoarseness 14/39 (35.9%) 17
    Cough 6/39 (15.4%) 8
    Dyspnea 5/39 (12.8%) 5
    Hiccups 2/39 (5.1%) 2
    Productive cough 2/39 (5.1%) 2
    Epistaxis 1/39 (2.6%) 1
    Hypoxia 1/39 (2.6%) 1
    Laryngeal inflammation 1/39 (2.6%) 1
    Nasal congestion 1/39 (2.6%) 1
    Pleural effusion 1/39 (2.6%) 2
    Respiratory, thoracic and mediastinal disorders - Other 1/39 (2.6%) 1
    Skin and subcutaneous tissue disorders
    Pamar-plantar erythrodysesthesia syndrome 14/39 (35.9%) 43
    Rash maculo-papular 6/39 (15.4%) 11
    Rash acneiform 4/39 (10.3%) 7
    Pruritus 3/39 (7.7%) 4
    Alopecia 2/39 (5.1%) 2
    Dry skin 2/39 (5.1%) 2
    Skin and subcutaneous tissue disorders -Other 2/39 (5.1%) 4
    Photosensitivity 1/39 (2.6%) 1
    Vascular disorders
    Hypertension 22/39 (56.4%) 48
    Flushing 2/39 (5.1%) 2
    Hypotension 2/39 (5.1%) 2
    Thromboembolic event 2/39 (5.1%) 2
    Hot flashes 1/39 (2.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Richard Kim, MD
    Organization Moffitt Cancer Center
    Phone 813-745-1432
    Email Richard.Kim@moffitt.org
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT02115542
    Other Study ID Numbers:
    • MCC-17651
    First Posted:
    Apr 16, 2014
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Sep 1, 2021