Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120939
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : April 3, 2009
Information provided by:
Pharmacyclics LLC.

July 12, 2005
July 19, 2005
April 3, 2009
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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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Complete list of historical versions of study NCT00120939 on Archive Site
Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks
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Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer
Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors
The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.
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Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Lung Neoplasms
  • Gastrointestinal Neoplasms
Drug: Motexafin Gadolinium
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Pharmacyclics LLC.
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Principal Investigator: Gurkamal Chatta, MD University of Pittsburgh
Pharmacyclics LLC.
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP