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A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Delta-Like Protein 3-Expressing Extensive Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02819999
Recruitment Status : Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Stemcentrx

Brief Summary:
The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Rovalpituzumab Tesirine Drug: Cisplatin Drug: Etoposide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Rovalpituzumab Tesirine (SC16LD6.5) in the Frontline Treatment of Patients With Delta-Like Protein 3-Expressing Extensive Stage Small Cell Lung Cancer
Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Etoposide

Arm Intervention/treatment
Experimental: Rovalpituzumab Tesirine
Rovalpituzumab Tesirine 0.3 mg/kg IV infusion
Drug: Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
Other Name: SC16LD6.5

Experimental: Rovalpituzumab Tesirine followed by Cisplatin, Etoposide
Rovalpituzumab Tesirine 0.3 mg/kg IV infusion followed by Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion
Drug: Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
Other Name: SC16LD6.5

Drug: Cisplatin
Drug: Etoposide
Experimental: Rovalpituzumab Tesirine with Cisplatin, Etoposide
Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion and Rovalpituzumab Tesirine 0.1 mg/kg IV infusion
Drug: Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
Other Name: SC16LD6.5

Drug: Cisplatin
Drug: Etoposide
Experimental: Rovalpituzumab Tesirine following Cisplatin, Etoposide
Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion followed by Rovalpituzumab Tesirine 0.3 mg/kg IV infusion
Drug: Rovalpituzumab Tesirine
Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
Other Name: SC16LD6.5

Drug: Cisplatin
Drug: Etoposide



Primary Outcome Measures :
  1. Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with delta-like protein 3 (DLL3)-expressing extensive-stage small cell lung cancer (SCLC) [ Time Frame: within 21 days after first dose of rovalpituzumab tesirine ]
    For Phase 1a

  2. Treatment emergent adverse events (TEAEs) [ Time Frame: through 30 days after last dose of study treatment ]
    For Phase 1a

  3. Incidence of subjects with CTCAE Grade >2 laboratory abnormalities [ Time Frame: through 30 days after last dose of study treatment ]
    For Phase 1a

  4. Progression-Free Survival (PFS) [ Time Frame: 4 years ]
    For Phase 1b


Secondary Outcome Measures :
  1. Best overall response rate [ Time Frame: 4 years ]
  2. Duration of response (DOR) [ Time Frame: 4 years ]
  3. Clinical Benefit Rate (CBR) [ Time Frame: 4 years ]
  4. Overall Survival (OS) [ Time Frame: 4 years ]
  5. Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine [ Time Frame: 4 years ]
  6. Progression-free survival (Phase 1a) [ Time Frame: 4 years ]
  7. Pharmacokinetic parameters: Cmax (Maximum plasma concentration observed ) [ Time Frame: 4 years ]
  8. Pharmacokinetic parameters: AUC0-tau (Area under the plasma concentration-time curve within a dosing interval) [ Time Frame: 4 years ]
  9. Pharmacokinetic parameters: AUC0-∞ (Area under the curve from time 0 extrapolated to infinity) [ Time Frame: 4 years ]
  10. Pharmacokinetic parameters: Tmax (Time of Cmax) [ Time Frame: 4 years ]
  11. Pharmacokinetic parameters: Ctrough (Observed plasma concentrations at trough) [ Time Frame: 4 years ]
  12. Pharmacokinetic parameters: T1/2 (Terminal half-life) [ Time Frame: 4 years ]
  13. Pharmacokinetic parameters: CL (Clearance) [ Time Frame: 4 years ]
  14. Pharmacokinetic parameters: Vss (Volume of distribution at steady state) [ Time Frame: 4 years ]
  15. Incidence of TEAEs [ Time Frame: 4 years ]
    For Phase 1b

  16. Changes in vital signs (Heart Rate) [ Time Frame: 4 years ]
  17. Changes in vital signs (Blood pressure) [ Time Frame: 4 years ]
  18. Changes in vital signs (Temperature) [ Time Frame: 4 years ]
  19. Changes in vital signs (Weight) [ Time Frame: 4 years ]
  20. Changes in vital signs (Respirations) [ Time Frame: 4 years ]
  21. Eastern Cooperative Oncology Group (ECOG) score [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve SCLC
  • DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive is defined as staining in ≥75% of tumor cells.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Minimum life expectancy of at least 12 weeks.
  • Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug.
  • Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb, total bilirubin, ALT, AST and GFR)
  • Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids
  • Use of effective contraception method during and for 1 year following study drug dosing if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) SCLC.
  • Any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study.
  • Documented history of a cerebral vascular, 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.
  • Women who are pregnant or breastfeeding.
  • History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.
  • Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819999


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80010
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
Cancer Institute of Florida
Orlando, Florida, United States, 32804
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Texas Oncology
Fort Worth, Texas, United States, 76104
Texas Oncology
San Antonio, Texas, United States, 78258
Sponsors and Collaborators
Stemcentrx
Investigators
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Study Director: Sreeni Yalamanchili, PharmD Stemcentrx

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Responsible Party: Stemcentrx
ClinicalTrials.gov Identifier: NCT02819999     History of Changes
Other Study ID Numbers: SCRX001-004
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Etoposide
Etoposide phosphate
Immunoconjugates
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs