NCT03086239

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

9 months

First QC Date

March 17, 2017

Last Update Submit

July 28, 2021

Conditions

Small Cell Lung Cancer

Keywords

Advanced, Recurrent Small Cell Lung CancerSmall Cell Lung CancerRovalpituzumab tesirineCancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with dose-limiting toxicities (DLT)

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

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

Secondary Outcomes (5)

  • Duration of response (DOR)

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

  • Objective Response Rate (ORR)

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

  • Overall survival (OS)

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

  • Progression-free survival (PFS)

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

  • Clinical benefit rate (CBR)

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

Study Arms (2)

Part A: Rovalpituzumab tesirine

EXPERIMENTAL

Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle

Drug: Rovalpituzumab tesirine

Part B: Rovalpituzumab tesirine

EXPERIMENTAL

Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).

Drug: Rovalpituzumab tesirine

Interventions

Rovalpituzumab tesirineDRUG

Intravenous

Part A: Rovalpituzumab tesirinePart B: Rovalpituzumab tesirine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

National Cancer Ctr Hosp East /ID# 161432

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Kyushu University Hospital /ID# 161430

Fukuoka, Fukuoka, 812-8582, Japan

Location

Kinki University -Osakasayama Campus /ID# 161431

Osakasayama-shi, Osaka, 589-8511, Japan

Location

National Cancer Center Hospital /ID# 161429

Chuo-ku, Tokyo, 104-0045, Japan

Location

Wakayama Medical University /ID# 161428

Wakayama, 641-8510, Japan

Location

Related Publications (2)

  • Udagawa H, Akamatsu H, Tanaka K, Takeda M, Kanda S, Kirita K, Teraoka S, Nakagawa K, Fujiwara Y, Yasuda I, Okubo S, Shintani M, Kosloski MP, Scripture C, Tamura T, Okamoto I. Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer. Lung Cancer. 2019 Sep;135:145-150. doi: 10.1016/j.lungcan.2019.07.025. Epub 2019 Jul 24.

    PMID: 31446987BACKGROUND

  • Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

    PMID: 29290251DERIVED

MeSH Terms

Conditions

Small Cell Lung CarcinomaNeoplasms

Interventions

rovalpituzumab tesirine

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 22, 2017

Study Start

April 28, 2017

Primary Completion

January 30, 2018

Study Completion

August 20, 2018

Last Updated

August 3, 2021

Record last verified: 2021-07

Locations

JP(5)