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Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
Pharmacyclics LLC.
ClinicalTrials.gov Identifier:
NCT00120939
First received: July 12, 2005
Last updated: April 2, 2009
Last verified: May 2007
July 12, 2005
April 2, 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 ClinicalTrials.gov 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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Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00120939
PCYC-0212
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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