Small Cell Lung CancerPhase 1NCT03086239
A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
A Phase 1 study testing Rovalpituzumab tesirine in people with Small Cell Lung Cancer, run by AbbVie at 5 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Rovalpituzumab tesirine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 5 sitesJapan
- Study dates
- 28 Apr 2017to 20 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
National Cancer Center Hospital /ID# 161429
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital /ID# 161430
Fukuoka, Fukuoka, 812-8582
National Cancer Ctr Hosp East /ID# 161432
Kashiwa-shi, Chiba, 277-8577
Kinki University -Osakasayama Campus /ID# 161431
Osakasayama-shi, Osaka, 589-8511
Wakayama Medical University /ID# 161428
Wakayama, 641-8510
About this study
Official title: An Open-Label 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).
- Conditions
- Small Cell Lung Cancer
- Being tested
- Rovalpituzumab tesirine
- Keywords
- Advanced, Recurrent Small Cell Lung Cancer, Small Cell Lung Cancer, Rovalpituzumab tesirine, Cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rovalpituzumab tesirineDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Drug: Rovalpituzumab tesirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
Secondary outcomes (5)
Duration of response (DOR)
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measured: 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)
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.
Measured: 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)
OS is defined as the time from the date of first dose to the date of death.
Measured: First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
Progression-free survival (PFS)
PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.
Measured: 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)
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.
Measured: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start28 Apr 2017
- Primary completion30 Jan 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086239
- Sponsor's protocol ID
- SCRX001-008
- Status last verified
- Jul 2021
- First submitted
- 17 Mar 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31446987Tanaka 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.
PubMed 29290251
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03086239
- Acronym / sponsor ID
- SCRX001-008
- Conditions
- Small Cell Lung Cancer
- Keywords
- Advanced, Recurrent Small Cell Lung Cancer, Small Cell Lung Cancer, Rovalpituzumab tesirine, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Rovalpituzumab tesirine | Experimental | Drug: Rovalpituzumab tesirinePart A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle |
| Part B: Rovalpituzumab tesirine | Experimental | Drug: Rovalpituzumab tesirinePart B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rovalpituzumab tesirineIntravenous | Drug | Part A: Rovalpituzumab tesirine, Part B: Rovalpituzumab tesirine |
Primary outcome
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.
5 secondary outcomes
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.
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.
Overall survival (OS)
Time frame: First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 31446987Udagawa 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.
- Derived from this study: PubMed 29290251Tanaka 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rovalpituzumab tesirine in people with Small Cell Lung Cancer, run by AbbVie at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086239, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.