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Non-Small-Cell Lung CancerPhase 1/2NCT02495233

A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

A Phase 1/2 study testing Gilteritinib and Erlotinib in people with Non-Small-Cell Lung Cancer, run by Astellas Pharma Global Development, Inc. at 4 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
Gilteritinib and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesJapan
Study dates
8 Sep 2015to 28 Sep 2016
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Participant had an ongoing toxicity greater than or equal to grade 3 (NCI CTCAE version 4.03) attributable to prior NSCLC treatment at the time of screening.
  • Participant received any agent with antitumor activity (other than an EGFR inhibitor, including a T790M inhibitor) including chemotherapy, radiotherapy, immunotherapy, within 14 days prior to the first dose of study drug (palliative radiotherapy is allowed).
  • Participant received ASP2215 previously.
  • Participant received blood transfusions or hematopoietic growth factor therapy within 14 days prior to the first dose of study drug.
  • Participant had a major surgical procedure (other than study-related biopsy) within 14 days prior to the first dose of study drug, or a major surgical procedure was planned to occur during the study.
  • Participant had active hepatitis B or C or other active hepatic disorder.
Show all 26Show fewer
  • Participant t was known to have human immunodeficiency virus (HIV) infection.
  • Participant had symptomatic central nervous system (CNS) metastasis. Participants with asymptomatic, untreated CNS metastases were allowed. Participants with previously treated and currently asymptomatic CNS metastases were eligible provided they met the following:
  • Any whole brain radiotherapy (WBRT) was completed at least 2 weeks prior to the first dose of study drug.
  • Any stereotactic radiosurgery (SRS) was completed at least 1 week prior to the first dose of study drug.
  • Participant did not require steroids or did not require escalating doses of steroids for at least 2 weeks prior to the first dose of study drug.
  • Participant had evidence of active infection requiring systemic therapy within 14 days prior to the first dose of study drug.
  • Participant had uncontrolled hypertension.
  • Participant had severe or uncontrolled systemic diseases or active bleeding diatheses.
  • Participant had history of drug-induced interstitial lung disease or any evidence of active interstitial lung disease.
  • Participant had ongoing cardiac arrhythmia (including atrial fibrillation) that was grade ≥ 2.
  • Participant currently had Class 3 or 4 New York Heart Association congestive heart failure.
  • Participant had history of severe/unstable angina, myocardial infarction or cerebrovascular accident within 6 months prior to the first dose of study drug.
  • Participant had history of gastrointestinal ulcer within 28 days prior to the first dose of study drug.
  • Participant had a history of gastrointestinal bleeding within 90 days prior to the first dose of study drug.
  • Participant had concurrent corneal disorder or any ophthalmologic condition which makes the participant unsuitable for study participation .
  • Participant had any condition which made the participant unsuitable for study participation.
  • Participant had hypokalemia or hypomagnesemia at screening.
  • Participant had QTcF interval > 450 ms on 12-lead ECG at screening.
  • Participant was known to have long QT syndrome.
  • Participant was taking medication known to prolong the QT interval.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Site JP81004

    Fukuoka Minami-ku, Fukuoka

  • Site JP81005

    Osakasayama, Osaka

  • Site JP81003

    Suntogun Nagaizumicho,Shizuoka

  • Site JP81002

    Tokyo

Other trials in Japan

About this study

Official title: A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.

Read the detailed description

No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.

Being tested
Gilteritinib, Erlotinib
Keywords
Erlotinib, ASP2215, NSCLC, Gilteritinib, Non-Small-Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GilteritinibDrug

    oral

  • ErlotinibDrug

    Also called Tarceva

    oral

Study groups in NCT02495233
Study groupRoleWhat they receive
Gilteritinib 120mg + Erlotinib 150mgExperimentalGilteritinib was administered in combination with erlotinib orally once daily.
Receives: Drug: Gilteritinib; Drug: Erlotinib
Gilteritinib 80mg+ Erlotinib 150mgExperimentalGilteritinib was administered in combination with erlotinib orally once daily.
Receives: Drug: Gilteritinib; Drug: Erlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    Measured: Cycle 1 and Cycle ≥2 (up to 141 days)

  2. Number of Participants With Adverse Events

    Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.

    Measured: From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)

Secondary outcomes (9)

  1. Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib

    Measured: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1

  2. Maximum Concentration (Cmax) for Gilteritinib

    Measured: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1

  3. Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib

    Measured: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1

  4. Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib

    All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.

    Measured: Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4

  5. AUC24 of Erlotinib

    Measured: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1

  6. Cmax of Erlotinib

    Measured: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1

  7. Tmax of Erlotinib

    Measured: 0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1

  8. Ctrough of Erlotinib

    Measured: Day 8, 15, 22, 28 of cycle 1

  9. Objective Response Rate (ORR) in Phase 1b

    ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.

    Measured: End of treatment (approximately 4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study start8 Sep 2015
  3. Primary completion28 Sep 2016
  4. Study completion28 Sep 2016

Why it stopped: Study terminated due to adverse events related to the combination therapy

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495233
Sponsor's protocol ID
2215-CL-5101
Status last verified
Nov 2024
First submitted
8 Jul 2015
Last updated
27 Nov 2024
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gilteritinib and Erlotinib in people with Non-Small-Cell Lung Cancer, run by Astellas Pharma Global Development, Inc. at 4 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 0 inclusion and 26 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: stopped early, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (DLTs) (time frame: Cycle 1 and Cycle ≥2 (up to 141 days)). The study lists 2 primary outcomes in all. 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 NCT02495233.

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 27 Nov 2024.

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