A Long-Term Study of Rovalpituzumab Tesirine

NCT03543358 | Completed Phase 2 Results FDA Drug

• 1 other identifier: M16-291
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

rovalpituzumab tesirine; rollover study; cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Arm A: Post-Treatment Follow-Up/Optional Retreatment

EXPERIMENTAL

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

Arm B: Continued Treatment

EXPERIMENTAL

Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.

Drug: rovalpituzumab tesirine

Interventions

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

Also known as: SC16LD6.5

Arm A: Post-Treatment Follow-Up/Optional Retreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects not previously enrolled in a rovalpituzumab tesirine study.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

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

Tucson, Arizona, 85704, United States

Location

City of Hope National Medical Center /ID# 204885

Duarte, California, 91010-3012, United States

Location

Univ of Pittsburgh Med Ctr /ID# 204763

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

rovalpituzumab tesirine

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: September 10, 2018
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

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.

Locations

US (3)