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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00120939 |
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Date of registration:
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12/07/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer
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Scientific title:
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Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00120939 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Gurkamal Chatta, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 18 years old
- Metastatic, or unresectable solid tumors from breast, head, and neck,
gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma
multiforme
- ECOG performance status score either 0, 1, or 2
- Willing and able to provide written informed consent
Exclusion Criteria:
- Greater than two prior cytotoxic regimens
- Laboratory values showing adequate function of bone marrow, liver, and kidneys
- Uncontrolled hypertension
- Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel,
docetaxel) or polysorbate 80
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Prostatic Neoplasms
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Gastrointestinal Neoplasms
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Lung Neoplasms
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Ovarian Neoplasms
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Intervention(s)
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Drug: Motexafin Gadolinium
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Primary Outcome(s)
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Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
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Secondary Outcome(s)
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Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks
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Secondary ID(s)
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PCYC-0212
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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