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Completed

NCT Number: NCT03543358

A Long-Term Study of Rovalpituzumab Tesirine

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rovalpituzumab tesirine

Drug

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 names: SC16LD6.5

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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