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A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)

Inclusion Criteria


Inclusion criteria:

- Signed written informed consent

- Male and female patients > or = 18 years of age with a solid tumor(s) that is locally
advanced or metastatic for which single agent carboplatin, or docetaxel or
capecitabine would be appropriate

- Measurable disease

- Immunohistochemical evidence of N-cadherin expression in tumor tissue

- Adequate performance status and organ function, as evidenced by hematological and
biochemical blood testing and ECG

Exclusion criteria:

- Receipt of ADH-1 prior to this clinical study

- Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before
study entry

- History of spinal cord compression, or history of primary brain tumor(s) or brain
metastases (known or suspected) unless any lesions have completely resolved following
appropriate treatment and there has been no recurrence for at least 6 months

- History of tumors that have shown clinically significant evidence of active bleeding
within 12 weeks before study entry

- Stroke, major surgery, or other major tissue injury within 4 weeks before study entry

- Uncontrolled congestive heart failure, coronary artery disease, or life threatening
arrhythmias; myocardial infarction within 12 months; significant electrocardiogram
(ECG) abnormalities, or known hypercoagulable states

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

AHX-01-006

NCT ID:

NCT00390676

Start Date:

November 2006

Completion Date:

November 2009

Related Keywords:

  • Neoplasms
  • cancer
  • tumors
  • anticarcinogenic agents
  • antineoplastic agents
  • cadherins
  • solid tumors
  • Neoplasms

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Rocky Mountain Cancer CentersThornton, Colorado  80260
Tyler Cancer CenterTyler, Texas  75702
Cancer Centers of FloridaOrlando, Florida  32806
Texas Oncology, PADallas, Texas  75246-2006
Central Indiana Cancer CentersIndianapolis, Indiana  46227
New York Oncology Hematology P.C.Albany, New York  12208
Northwest Cancer Specialists - Vancouver Cancer CenterVancouver, Washington  98684
Dayton Oncology & Hematology, P.AKettering, Ohio  45409