Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies

Part of paid clinical trials in Dallas, Texas.

Sponsor: Metronome Therapeutics
Study ID: NCT00641160
Phase: PHASE1
Status: Unknown

Conditions

Nonhematologic Malignancies

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

vinorelbine tartrate — DRUG
Dose Level #1 PO for at least 7 days
vinorelbine tartrate — DRUG
Dose Level #2 PO for at least 7 days
vinorelbine tartrate — DRUG
Dose Level #3 PO for at least 7 days

Study Details

The purpose of this study is to determine the safety of oral administration of vinorelbine once daily for at least 7 days. The study will be conducted in subjects with a non-hematologic malignancy for which there are no currently accepted therapies.

Key Dates

Start date: Mar 31, 2008
Status verified: Sep 2008
Primary completion: Nov 30, 2008
Completion: Nov 30, 2008

Study Design

Enrollment: 12 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Cohort 1
Experimental: Cohort 2
Experimental: Cohort 3

Primary Outcome Measure

Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs [ Time Frame: Assessed at each subject visit to the study center ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Texas Oncology PA; Sammons Cancer Center	Dallas	Texas	75246	-

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By research site

Texas Oncology PA; Sammons Cancer Center· Dallas, TX