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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03543358
Other study ID # M16-291
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 10, 2018
Est. completion date November 26, 2019

Study information

Verified date December 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date November 26, 2019
Est. primary completion date November 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
United States City of Hope National Medical Center /ID# 204885 Duarte California
United States Univ of Pittsburgh Med Ctr /ID# 204763 Pittsburgh Pennsylvania
United States Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818 Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE) 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. From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.
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