A Phase 1 interventional study of E7080 and E7080 in Non-small-cell Lung Cancer, sponsored by Eisai Co., Ltd.. Completed at 3 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by Eisai Co., Ltd. · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 28 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Exclusion criteria:
Subjects who have ever received the following therapy for non-small cell lung cancer (NSCLC):
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.
Drug: E7080 · Drug: Paclitaxel · Drug: Carboplatin
Dosage of E7080 for Expansion Cohort will be determined based on the maximum tolerated dose in the Dose-Escalation Cohort.
Drug: E7080 · Drug: Paclitaxel · Drug: Carboplatin
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).
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).
Paclitaxel (200 mg/m2) will be administered intravenously (IV) on Day 1 after administration of E7080.
Carboplatin (AUC 6.0 min/mg/mL) will be administered IV on Day 1 after administration of E7080 and Paclitaxel.
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.
Time frame: 7 days during the run-in period (Cycle 0) and 3 weeks (21 days) from Cycle 1
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.
Refer safety section for safety analysis
Time frame: Throughout the study until 30 days after last dose
| Milestone | E7080 4 mg BID (Dose Escalation) | E7080 6 mg BID (Dose Escalation) | E7080 4 mg BID (Expansion) |
|---|---|---|---|
| Started | 6 | 6 | 16 |
| Completed | 6 | 5 | 15 |
| Not completed | 0 | 1 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
Results for this outcome have not been posted.
Tolerability was confirmed by the frequency of occurrence of Dose Limiting Toxicities (DLTs) observed by the end of Cycle 1 in 6 participants.
| mg BID | E7080 6 mg BID (Dose Escalation) |
|---|---|
| Maximum Tolerated Dose (MTD) | 4 |
Results for this outcome have not been posted.
Refer safety section for safety analysis
Results for this outcome have not been posted.
Collected over Throughout the study until 30 days after last dose. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| E7080 4 mg BID (Dose Escalation) | — | 3/6 (50%) | 6/6 (100%) |
| E7080 6 mg BID (Dose Escalation) | — | 2/6 (33.3%) | 6/6 (100%) |
| E7080 4 mg BID (Expansion) | — | 6/16 (37.5%) | 16/16 (100%) |
| Event | E7080 4 mg BID (Dose Escalation) | E7080 6 mg BID (Dose Escalation) | E7080 4 mg BID (Expansion) |
|---|---|---|---|
| SyncopeNervous system disorders | 0/6 | 1/6 | 0/16 |
| WoundInjury, poisoning and procedural complications | 0/6 | 1/6 | 0/16 |
| HaematomaVascular disorders | 0/6 | 1/6 | 0/16 |
| PneumoniaInfections and infestations | 1/6 | 1/6 | 0/16 |
| Lymphangiosis carcinomatosaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/6 | 0/6 | 0/16 |
| Decreased AppetiteMetabolism and nutrition disorders | 1/6 | 0/6 | 0/16 |
| PyelonephritisInfections and infestations | 1/6 | 0/6 | 0/16 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/6 | 0/6 | 2/16 |
| VomitingGastrointestinal disorders | 0/6 | 0/6 | 1/16 |
| Abdominal painGastrointestinal disorders | 0/6 | 0/6 | 1/16 |
| Event | E7080 4 mg BID (Dose Escalation) | E7080 6 mg BID (Dose Escalation) | E7080 4 mg BID (Expansion) |
|---|---|---|---|
| LeukopeniaBlood and lymphatic system disorders | 6/6 | 5/6 | 15/16 |
| NeutropeniaBlood and lymphatic system disorders | 6/6 | 5/6 | 15/16 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/6 | 4/6 | 16/16 |
| DiarrhoeaGastrointestinal disorders | 6/6 | 4/6 | 12/16 |
| NauseaGastrointestinal disorders | 5/6 | 6/6 | 13/16 |
| Aspartate aminotransferase increasedInvestigations | 4/6 | 6/6 | 5/16 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/6 | 5/6 | 16/16 |
| Peripheral sensory neuropathyNervous system disorders | 6/6 | 5/6 | 15/16 |
| ProteinuriaRenal and urinary disorders | 6/6 | 3/6 | 11/16 |
| AlopeciaSkin and subcutaneous tissue disorders | 6/6 | 5/6 | 15/16 |
| Age, Continuous(Years) | E7080 4 mg BID (Dose Escalation) | E7080 6 mg BID (Dose Escalation) | E7080 4 mg BID (Expansion) | Total |
|---|---|---|---|---|
| Mean | 52.8 ± 9.3 | 54.8 ± 9.7 | 58.4 ± 11.2 | 56.4 ± 10.4 |
| Sex: Female, Male(Participants) | E7080 4 mg BID (Dose Escalation) | E7080 6 mg BID (Dose Escalation) | E7080 4 mg BID (Expansion) | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 3 | 7 |
| Male | 4 | 4 | 13 | 21 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Eisai Co., Ltd.