Study Stopped
Strategic considerations
Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors
1 other identifier
interventional
200
1 country
30
Brief Summary
The primary objective of this study is to assess the safety and tolerability of rovalpituzumab tesirine in subjects with specific delta-like protein 3-expressing advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2016
Typical duration for phase_1
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedStudy Start
First participant enrolled
September 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2019
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedOctober 19, 2020
September 1, 2020
2.9 years
March 2, 2016
August 11, 2020
September 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Summary of Treatment-Emergent Adverse Events (TEAEs), by Dose and Neuroendocrine (NEC) or Non-NEC Disease Groups
The number of participants with TEAEs, serious TEAEs, study drug-related TEAEs, and study drug discontinuations or dose reductions due to TEAEs, summarized by dose received and neuroendocrine (NEC) or non-NEC disease groups. An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.
From first dose of study drug through 30 days after last dose. The overall mean number of 6-week treatment cycles was 1 (range 1.0, 5.0).
Secondary Outcomes (7)
Objective Response Rate (ORR)
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Clinical Benefit Rate (CBR)
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Duration of Response (DOR)
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Progression Free Survival (PFS)
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
Overall Survival (OS)
Baseline, every 6 weeks until 6 months, then every 12 weeks until disease progression, assessed up to 35.2 months.
- +2 more secondary outcomes
Study Arms (1)
Rovalpituzumab Tesirine
EXPERIMENTALRovalpituzumab tesirine 0.2-0.4 mg/kg administered intravenously on Day 1 of each 6-week cycle. Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6-week cycle.
Interventions
Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).
Eligibility Criteria
You may qualify if:
- Histologically confirmed, unresectable advanced solid malignancy with documented disease progression after at least 1 prior systemic therapy
- Disease is relapsed/refractory to prior standard systemic therapy or for which standard or curative therapy does not exist or is not considered appropriate by the Investigator.
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Delta-like protein 3 (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:
- Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks.
- Immune-checkpoint inhibitors (e.g., anti-programmed death protein 1 \[PD-1\], anti-programmed death-ligand 1 \[PD-L1\], or anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\]), 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 (β-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.
You may not qualify if:
- 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 within 6 months prior to their first dose of study drug.
- Recent or ongoing serious infection, including:
- Any active grade 3 or higher (per National Cancer Institute Common Terminology Criteria for Adverse Events version \[NCI CTCAE\] 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted.
- Known seropositivity for or active infection by human immunodeficiency virus (HIV).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (30)
Banner MD Anderson Cancer Ctr /ID# 155424
Gilbert, Arizona, 85234, United States
Mayo Clinic - Scottsdale /ID# 155419
Scottsdale, Arizona, 85259, United States
University of California, Los Angeles /ID# 155429
Los Angeles, California, 90095, United States
Univ California, San Francisco /ID# 155409
San Francisco, California, 94143-2204, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 155428
West Hollywood, California, 90048, United States
Univ of Colorado Cancer Center /ID# 155415
Aurora, Colorado, 80045, United States
Sarah Cannon Research Institute at HealthONE - Denver /ID# 155420
Denver, Colorado, 80218, United States
University of Florida - Archer /ID# 155414
Gainesville, Florida, 32610, United States
Moffitt Cancer Center /ID# 170220
Tampa, Florida, 33612-9416, United States
Emory University Hospital /ID# 155417
Atlanta, Georgia, 30322, United States
University of Kentucky Chandler Medical Center /ID# 155423
Lexington, Kentucky, 40536, United States
Johns Hopkins University /ID# 155412
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital /ID# 155411
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute /ID# 171044
Boston, Massachusetts, 02215, United States
Mayo Clinic - Rochester /ID# 155416
Rochester, Minnesota, 55905-0001, United States
Washington University-School of Medicine /ID# 155425
St Louis, Missouri, 63110, United States
Rutgers Cancer Institute of NJ /ID# 162010
New Brunswick, New Jersey, 08903, United States
University of New Mexico /ID# 205054
Albuquerque, New Mexico, 87102, United States
Roswell Park Comprehensive Cancer Center /ID# 162015
Buffalo, New York, 14263, United States
Weill Cornell Medical College /ID# 155418
New York, New York, 10021, United States
Duke University Medical Center /ID# 155421
Durham, North Carolina, 27710-3000, United States
Univ Hosp Cleveland /ID# 155410
Cleveland, Ohio, 44106, United States
Oregon Health and Science University /ID# 162011
Portland, Oregon, 97239, United States
Greenville Hospital System /ID# 155427
Greenville, South Carolina, 29605, United States
Mary Crowley Cancer Research /ID# 162014
Dallas, Texas, 75230, United States
Texas Oncology - Forth Worth /ID# 162045
Fort Worth, Texas, 76104-2150, United States
University of Texas MD Anderson Cancer Center /ID# 155413
Houston, Texas, 77030, United States
University of Utah /ID# 155426
Salt Lake City, Utah, 84112-5500, United States
Virginia Cancer Specialists /ID# 162006
Fairfax, Virginia, 22031, United States
Northwest Cancer Specialists, P.C. /ID# 155431
Vancouver, Washington, 98684, United States
Related Publications (1)
Xie H, Kaye FJ, Isse K, Sun Y, Ramoth J, French DM, Flotte TJ, Luo Y, Saunders LR, Mansfield AS. Delta-Like Protein 3 Expression and Targeting in Merkel Cell Carcinoma. Oncologist. 2020 Sep;25(9):810-817. doi: 10.1634/theoncologist.2019-0877. Epub 2020 May 14.
PMID: 32372416DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2016
First Posted
March 16, 2016
Study Start
September 23, 2016
Primary Completion
August 27, 2019
Study Completion
August 27, 2019
Last Updated
October 19, 2020
Results First Posted
October 19, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.