Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02709889 : Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
PhasePhase 1/Phase 2
AgesMin: N/A Max: N/A
Eligibility
Inclusion Criteria:

- Histologically confirmed, unresectable advanced solid malignancy with documented
disease progression after at least 1 prior systemic therapy

- Measurable disease as defined by RECIST 1.1

- DLL3-expressing malignancy based on central immunohistochemical (IHC) testing of
representative baseline tumor tissue (archived tissue or on-study biopsy). Positive is
defined as staining in ? 1% of tumor cells.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Minimum life expectancy of at least 12 weeks

- Subjects with a history of central nervous system (CNS) metastases must have
documentation of stable or improved brain imaging for at least 2 weeks after
completion of definitive treatment and within 2 weeks prior to first dose of Study
Drug, off or on a stable dose of corticosteroids. Definitive treatment may include
surgical resection, whole brain irradiation, and/or stereotactic radiation therapy.
(Applicable to tumor types of non-CNS primary origin only)

- Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior
to initiation of study drug administration

- Adequate hematologic and organ function as confirmed by laboratory values

- Last dose of any prior therapy administered by the following time intervals before the
first dose of study drug:

1. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational
anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.

2. Immune-checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4),
monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell
or other cell-based therapies: 4 weeks (2 weeks with documented disease
progression).

- Females of childbearing potential must have a negative beta human chorionic
gonadotropin (?-hCG) pregnancy test result within 7 days prior to the first dose of
study drug. Females of non-childbearing potential are those who are postmenopausal
greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.

Exclusion Criteria:

- Any significant medical condition, including any suggested by screening laboratory
findings that, in the opinion of the investigator or sponsor, may place the subject at
undue risk from the study, including but not necessarily limited to uncontrolled
hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic
obstructive pulmonary disease requiring hospitalization within 3 months) or
neurological disorder (e.g., seizure disorder active within 3 months).

- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association (NYHA) Class III-IV (see Appendix 12.4) within 6 months prior to
their first dose of study drug.

- Recent or ongoing serious infection, including:

1. Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or
fungal infection within 2 weeks of the first dose of the study drug. Routine
antimicrobial prophylaxis is permitted.

2. Known seropositivity for or active infection by human immunodeficiency virus
(HIV).

3. Active Hepatitis B (by surface antigen expression or polymerase chain reaction)
or C (by polymerase chain reaction) infection or on hepatitis-related antiviral
therapy within 6 months of first dose of study drug.

- Women who are pregnant or breastfeeding

- Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1
week prior to the first dose of study drug

- History of another invasive malignancy that has not been in remission for at least 3
years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively
treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in
situ on biopsy or squamous intraepithelial lesion on PAP smear.

- Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, prior participation in a
rovalpituzumab tesirine clinical trial, or known hypersensitivity to rovalpituzumab
tesirine or excipient contained in the drug formulation, unless undergoing retreatment
with rovalpituzumab tesirine in the context of this protocol
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02709889      |      Link to official Clinicaltrials.gov listing
Locations
Gilbert, Arizona
Facility: Banner MD Anderson Cancer Center
Investigator: Jiaxin Niu, MD
Contact: Phone: 855-256-6444
Email not avaialable

Phoenix, Arizona
Facility: Mayo Clinic Arizona
Investigator: Alan Bryce, MD
Contact: Phone: 855-776-0015
Email not avaialable

Los Angeles, California
Facility: Cedars-Sinai Medical Center
Investigator: Andrew Hendifar, MD
Contact: Phone: 310-423-2133
Email not avaialable

San Francisco, California
Facility: University of California San Francisco
Investigator: Rahul Aggarwal, MD
Contact: Phone: 877-827-3222
Click HERE to send email to this center

Aurora, Colorado
Facility: University of Colorado Denver
Investigator: Karl Lewis, MD
Contact: Phone: 720-848-0637
Email not avaialable

Denver, Colorado
Facility: Sarah Cannon Research Institute
Investigator: Gerald Falchook, MD
Contact: Phone: 720-754-2610
Email not avaialable

Gainesville, Florida
Facility: UF Health Cancer Center
Investigator: Frederic J Kaye, MD
Contact: Phone: 352-273-8675
Email not avaialable

Tampa, Florida
Facility: H. Lee Moffitt Cancer Center & Research Institute
Investigator: Heloisa Soares, MD
Contact: Phone: 888-663-3488
Email not avaialable

Atlanta, Georgia
Facility: Emory Winship Cancer Center
Investigator: Taofeek Owonikoko, MD
Contact: Phone: 404-778-1868
Email not avaialable

Lexington, Kentucky
Facility: University of Kentucky
Investigator: Anthony Lowell, MD
Contact: Phone: 866-340-4488
Email not avaialable

Baltimore, Maryland
Facility: Johns Hopkins University
Investigator: Christine Hann, MD
Contact: Phone: 410-464-6713
Email not avaialable

Boston, Massachusetts
Facility: Massachusetts General Hospital
Investigator: Anna Farago, MD
Contact: Phone: 877-420-3951
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Aaron Mansfield, MD
Contact: Phone: 507-284-2511
Email not avaialable

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Saiama Waqar, MD
Contact: Phone: 314-362-1000
Email not avaialable

New Brunswick, New Jersey
Facility: Rutgers Cancer Institute of New Jersey
Investigator: Jyoti Malhotra, MD
Contact: Phone: 732-235-8675
Email not avaialable

Buffalo, New York
Facility: Roswell Park Cancer Institute
Investigator: Grace K Dy, MD
Contact: Phone: 877-275-7724
Email not avaialable

New York, New York
Facility: Weill Cornell Medicine
Investigator: Himisha Beltran, MD
Contact: Phone: 646-962-8215
Email not avaialable

Durham, North Carolina
Facility: Duke University School of Medicine
Investigator: Tian Zhang, MD
Contact: Phone: 919-684-6342
Email not avaialable

Cleveland, Ohio
Facility: University Hospitals Cleveland Medical Center
Investigator: Afshin Dowlati, MD
Contact: Phone: 800-641-2422
Email not avaialable

Portland, Oregon
Facility: Oregon Health and Science University
Investigator: Matthew Taylor, MD
Contact: Phone: 503-494-1080
Email not avaialable

Greenville, South Carolina
Facility: Greenville Health System
Investigator: Ki Young Chung, MD
Contact: Phone: 864-455-7070
Email not avaialable

Dallas, Texas
Facility: Mary Crowley Cancer Research Center
Investigator: John Nemunaitis, MD
Contact: Phone: 972-566-3000
Email not avaialable

Fort Worth, Texas
Facility: Texas Oncology
Investigator: Stephen Richey, MD
Contact: Phone: 817-850-2230
Email not avaialable

Houston, Texas
Facility: MD Anderson Cancer Center
Investigator: David S. Hong
Contact: Phone: 855-590-5652
Email not avaialable

Salt Lake City, Utah
Facility: Huntsman Cancer Institute
Investigator: Jonathan Whisenant, MD
Contact: Phone: 888-424-2100
Email not avaialable

Fairfax, Virginia
Facility: Virginia Cancer Specialists
Investigator: Alexander I Spira, MD
Contact: Phone: 703-280-5390
Email not avaialable

Vancouver, Washington
Facility: Compass Oncology
Investigator: David Smith, MD
Contact: Phone: 360-944-9889
Email not avaialable




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