Non-small-cell Lung CancerPhase 1NCT00832819
E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study testing E7080, Paclitaxel and Carboplatin in people with Non-small-cell Lung Cancer, run by Eisai Co., Ltd. at 3 sites in Japan.
Trial summary
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- E7080, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesJapan
- Study dates
- Feb 2009to Oct 2011
- Phase
- Phase 1
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
- Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
- Subjects with Performance Status (PS) 0-1.
- Subjects with adequate organ function.
Who cannot join
- Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
- Chemotherapy
- Biological or immunotherapies
- Surgery for primary focus
- The radiation therapy for primary focus
- Subjects with the severe complications or disease history.
Show all 10Show fewer
- Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
- Subjects with simultaneous or metachronous cancers.
- Subjects who cannot take oral medication.
- Subjects who are using drugs that strongly inhibit or induce cytochrome P450 (CYP) 3A4.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Chuo-ku, Tokyo
Study site
Koto-ku, Tokyo
Study site
Sunto-gun, Shizuoka
About this study
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- E7080, Paclitaxel, Carboplatin
- Keywords
- Cancer, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7080Drug
Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1).
E7080Drug
Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL).
PaclitaxelDrug
Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
CarboplatinDrug
Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
| Study group | Role | What they receive |
|---|---|---|
| E7080 (Dose Escalation Cohort) | Experimental | This will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin. Receives: Drug: E7080; Drug: Paclitaxel; Drug: Carboplatin |
| E7080 (Expansion Cohort) | Experimental | Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort. Receives: Drug: E7080; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.
Measured: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
Secondary outcomes (3)
Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.
Measured: At Screening, on Day 22 of every even cycle, and at discontinuation
Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.
Measured: At various time points until Day 22 of Cycle 1
To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.
Refer safety section for safety analysis
Measured: Throughout the study until 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wataru Yusa, Study director, Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832819
- Sponsor's protocol ID
- E7080-J081-110
- Status last verified
- Feb 2015
- First submitted
- 23 Jan 2009
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Nishio M, Horai T, Horiike A, Nokihara H, Yamamoto N, Takahashi T, Murakami H, Yamamoto N, Koizumi F, Nishio K, Yusa W, Koyama N, Tamura T. Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. Br J Cancer. 2013 Aug 6;109(3):538-44. doi: 10.1038/bjc.2013.374. Epub 2013 Jul 16.
PubMed 23860537
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E7080 in Combination With Carboplatin and Paclitaxel in Patients With Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00832819
- Acronym / sponsor ID
- E7080-J081-110
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- Cancer, Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determined the maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 administered continually twice daily in combination with carboplatin and paclitaxel to patients with advanced or metastatic non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E7080 (Dose Escalation Cohort) | Experimental | Drug: E7080, Drug: Paclitaxel, Drug: CarboplatinThis will be a dose-escalation evaluation of 12-18 participants to determine the maximum tolerated dose of E7080 in combination with paclitaxel and carboplatin. |
| E7080 (Expansion Cohort) | Experimental | Drug: E7080, Drug: Paclitaxel, Drug: CarboplatinDosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
- Locally advanced and/or metastatic non-small cell lung cancer (NSCLC) (Stage IIIB/IV).
- Subjects with at least one measurable tumor lesion by Response Evaluation Criteria In Solid Tumors (RECIST).
- Subjects with Performance Status (PS) 0-1.
- Subjects with adequate organ function.
Key exclusion criteria (10 listed)
- Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
- Subjects with the severe complications or disease history.
- Subjects with brain metastasis accompanying clinical symptoms or requiring treatment.
- Subjects with simultaneous or metachronous cancers.
- Subjects who cannot take oral medication.
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 |
|---|---|---|
| E7080Drug: E7080 will be administered orally starting at a dose of 6 mg twice daily during the 7-day run-in period and for 3 weeks (Cycle 1). | Drug | E7080 (Dose Escalation Cohort) |
| E7080Maximum tolerated dose determined in the Dose-Escalation Cohort will be administered to the Expansion Cohort. After E7080 is taken on Day 1, paclitaxel (200 mg/m2) will be administered intravenously (IV), followed by IV carboplatin (AUC 6.0 min/mg/mL). | Drug | E7080 (Expansion Cohort) |
| PaclitaxelPaclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080. | Drug | E7080 (Dose Escalation Cohort), E7080 (Expansion Cohort) |
| CarboplatinCarboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel. | Drug | E7080 (Dose Escalation Cohort), E7080 (Expansion Cohort) |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.
3 secondary outcomes
Anti-tumor Effect of E7080 in Combination With Carboplatin and Paclitaxel.
Time frame: At Screening, on Day 22 of every even cycle, and at discontinuation
Pharmacokinetics and Pharmacodynamics of E7080 in Combination With Carboplatin and Paclitaxel.
Time frame: At various time points until Day 22 of Cycle 1
To Evaluate the Safety and Tolerability of E7080 in Combination With Carboplatin and Paclitaxel.
Time frame: Throughout the study until 30 days after last dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23860537Nishio M, Horai T, Horiike A, Nokihara H, Yamamoto N, Takahashi T, Murakami H, Yamamoto N, Koizumi F, Nishio K, Yusa W, Koyama N, Tamura T. Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. Br J Cancer. 2013 Aug 6;109(3):538-44. doi: 10.1038/bjc.2013.374. Epub 2013 Jul 16.
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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.
Wataru Yusa study director
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
3 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 E7080, Paclitaxel and Carboplatin in people with Non-small-cell Lung Cancer, run by Eisai Co., Ltd. at 3 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 5 inclusion and 10 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 6 Mar 2015). 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?
Maximum Tolerated Dose (MTD) (time frame: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from 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 NCT00832819, which also lists 1 linked publication.
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 30 Apr 2015.