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A Long-Term Study of Rovalpituzumab Tesirine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543358
Recruitment Status : Completed
First Posted : June 1, 2018
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.

Condition or disease Intervention/treatment Phase
Cancer Drug: rovalpituzumab tesirine Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : November 26, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Post-Treatment Follow-Up/Optional Retreatment
Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period.
 Drug: rovalpituzumab tesirine
Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles
Other Name: SC16LD6.5
Experimental: Arm B: Continued Treatment
Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.
 Drug: rovalpituzumab tesirine
Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
Other Name: SC16LD6.5


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE) [ Time Frame: From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years. ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs and serious TEAEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on AEs, please see the Adverse Event section.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.
  • Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.

For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:

  • Tolerated their initial 2 doses of rovalpituzumab tesirine.
  • Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.
  • Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.
  • Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematologic, kidney, and liver function, per protocol.
  • In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.

Exclusion Criteria:

  • Subjects not previously enrolled in a rovalpituzumab tesirine study.
Contacts and Locations
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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): NCT03543358


Locations
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United States, Arizona
Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818
Tucson, Arizona, United States, 85704
United States, California
City of Hope National Medical Center /ID# 204885
Duarte, California, United States, 91010-3012
United States, Pennsylvania
Univ of Pittsburgh Med Ctr /ID# 204763
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol and Statistical Analysis Plan  [PDF] May 20, 2019

More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03543358    
Other Study ID Numbers: M16-291
First Posted: June 1, 2018    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
rovalpituzumab tesirine
rollover study
cancer
Additional relevant MeSH terms:
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Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs