A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00121680
First received: July 15, 2005
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas.

Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.

In the current phase of this study, To determine the MTD and the pharmacokinetic profile of E7080 when given as continuous daily (qd) dosing in combination with temozolomide.


Condition Intervention Phase
Metastatic Melanoma
Drug: E7080
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions. [ Time Frame: Every two cycles. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Identify the dose limiting toxicities (DLT); explore safety and tolerability; determine pharmacokinetic profile; explore anti-tumor efficacy. [ Time Frame: Every two cycles. ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: July 2005
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7080
Oral.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with a histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no curative therapies are available All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved Aged 18 years. Because of the potential additional risk to children suggested by preclinical models of dysplasia in growing epiphyseal growth plates, enrollment will be limited to adult patients ECOG performance status score of 0 or 1 Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice Willing and able to comply with the protocol guidelines for the duration of the study For patients in the Schedule 2 Expanded Melanoma Cohort only: histologically and/or cytologically confirmed advanced and/or metastatic melanoma who are resistant/refractory to approved therapies or for whom no curative therapies are available. In addition, patients must have melanoma lesions amenable to tissue biopsy and must agree to undergo biopsies of malignant and adjacent non-malignant tissue pretreatment and at the end of Cycle 1 of treatment For patients in the Melanoma Combination Cohort only: histologically and/or cytologically confirmed melanoma that is advanced and/or metastatic

Exclusion Criteria:

Untreated or unstable metastases to the central nervous system (CNS) tumors. Patients who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and in whom stability has been proven by at least 2 CT or MRI scans obtained at least 4 weeks apart are permitted Any of the following laboratory parameters: hemoglobin < 9 g/dL (5.6 mmol/L); neutrophils <1.5 x 109/L; platelets <100 x 109/L; serum bilirubin >25 mol/L (1.5 mg/dL); liver function tests with values >3 x upper limit of normal (ULN); renal function with serum creatinine >1.5 ULN or creatinine clearance < 60 mL/min Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection Patients with centrally located non-small cell lung cancers and squamous cell lung cancers Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken <7 days per 28 days. However, if the patient requires chronic use (>/=7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded. Concomitant antiplatelet agents and NSAIDs should be used with caution Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) Poorly controlled hypertension (defined as requiring changes in any hypertensive regimen within 1 week three months of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening >1+ proteinuria on urine dipstick testing or 30 mg/dL A history of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within four weeks of starting therapy or who have not recovered from major surgery within three weeks of starting therapy History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance Any treatment with investigational drugs within 30 days before the start of the study Previous treatment with E7080 Known intolerance to temozolomide (or any of the excipients) Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the Investigator (revised per Amendment 04). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection Legal incapacity

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00121680

Locations
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai Inc. Eisai Limited
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00121680     History of Changes
Other Study ID Numbers: E7080-A001-102
Study First Received: July 15, 2005
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
cancer

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014