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Completed

NCT Number: NCT03086239

A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer

This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Ctr Hosp East /ID# 161432, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate hematologic, hepatic and renal function.

Exclusion criteria

  • No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.

Treatment and study plan

rovalpituzumab tesirine

Drug

Intravenous

Primary outcomes

  1. Number of participants with dose-limiting toxicities (DLT)

    Time frame: Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)

    DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

Secondary outcomes

  1. Duration of response (DOR)

    Time frame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.

    DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.

  2. Objective Response Rate (ORR)

    Time frame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  3. Overall survival (OS)

    Time frame: First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.

    OS is defined as the time from the date of first dose to the date of death.

  4. Progression-free survival (PFS)

    Time frame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.

    PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.

  5. Clinical benefit rate (CBR)

    Time frame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.

    CBR is defined as the proportion of participants whose overall response is either CR, PR, or Stable Disease (SD) according to RECIST version 1.1.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2017
Registry last updated
Aug 3, 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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