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Study of E7046 in Subjects With Selected Advanced Malignancies
Phase 1 trial testing E7046 in Tumors in 31 participants. Terminated before completion.
| Lead sponsor | Eisai Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 31 |
| Start date | 30 July 2015 |
| Primary completion | 27 February 2018 |
| Estimated completion | 27 February 2018 |
| Sites | 3 locations across France, United States |
Eisai Inc. — full company profile →
Adults 18 to 99, any sex, with Tumors. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| E7046 125 mg | 8 | |
| E7046 250 mg | 7 | |
| E7046 500 mg | 6 | |
| E7046 750 mg | 7 |
| Group | Value | 95% CI |
|---|---|---|
| E7046 125 mg | 5 | |
| E7046 250 mg | 6 | |
| E7046 500 mg | 3 | |
| E7046 750 mg | 3 |
| Group | Value | 95% CI |
|---|---|---|
| E7046: All Participants | NA |
Two RP2Ds were planned to be evaluated.
| Group | Value | 95% CI |
|---|---|---|
| E7046: All Participants | 250 |
| Group | Value | 95% CI |
|---|---|---|
| E7046: All Participants | 500 |
The ORR is the percentage of participants achieving a best overall response of confirmed immune-related partial response (irPR) + immune-related complete response (irCR), according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1, from first dose date until disease progression/recurrence.
| Group | Value | 95% CI |
|---|---|---|
| E7046 125 mg | 0 | 0 – 0 |
| E7046 250 mg | 0 | 0 – 0 |
| E7046 500 mg | 0 | 0 – 0 |
| E7046 750 mg | 0 | 0 – 0 |
PFS is defined as the time from first dose date to the date of the first documentation of confirmed disease progression or death, whichever occurs first, according to irRECIST v1.1. PFS was calculated using Kaplan-Meier product-limit method and Greenwood Formula.
| Group | Value | 95% CI |
|---|---|---|
| E7046 125 mg | 1.5 | 1.1 – 4.0 |
| E7046 250 mg | 1.4 | 1.1 – 4.1 |
| E7046 500 mg | 1.3 | 1.2 – 1.6 |
| E7046 750 mg | 1.3 | 0.9 – NA |
The DCR is percentage of participants achieving best overall response of confirmed irCR, irPR, or immune-related stable disease (irSD) (lasting at least 5 weeks), according to irRECIST v1.1 from the first dose date until disease progression/recurrence.
| Group | Value | 95% CI |
|---|---|---|
| E7046 125 mg | 25.0 | 3.2 – 65.1 |
| E7046 250 mg | 25.0 | 3.2 – 65.1 |
| E7046 500 mg | 0 | 0 – 0 |
| E7046 750 mg | 42.9 | 9.9 – 81.6 |
The CBR is the percentage of participants achieving irPR + irCR + irSD (lasting at least 24 weeks), according to irRECIST v1.1 from first dose date until disease progression/recurrence.
| Group | Value | 95% CI |
|---|---|---|
| E7046 125 mg | 0 | 0 – 0 |
| E7046 250 mg | 0 | 0 – 0 |
| E7046 500 mg | 0 | 0 – 0 |
| E7046 750 mg | 0 | 0 – 0 |
Time frame: From the first dose of study drug (Baseline) up to 30 days after the last dose of study drug (approximately up to 2 years). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | E7046 125 mg | E7046 250 mg | E7046 500 mg | E7046 750 mg |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Cardiopulmonary failure | Cardiac disorders | — | — | — | — |
| Myocardial infarction | Cardiac disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Duodenal stenosis | Gastrointestinal disorders | — | — | — | — |
| Large intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Death | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Bile duct obstruction | Hepatobiliary disorders | — | — | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — | — | — | — |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Dysarthria | Nervous system disorders | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | E7046 125 mg | E7046 250 mg | E7046 500 mg | E7046 750 mg |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Weight decreased | Investigations | — | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — | — | — |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Tachycardia | Cardiac disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Malaise | General disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Blood creatinine increased | Investigations | — | — | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
Most-reported serious reactions: Ascites, Dyspnoea, Cardiopulmonary failure, Myocardial infarction, Abdominal pain, Constipation, Duodenal stenosis, Large intestinal obstruction.
Data from ClinicalTrials.gov NCT02540291 adverse events section.
This is an open label, multicenter, Phase 1 study of E7046 to assess the safety and tolerability of E7046 and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of E7046.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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