Status:
COMPLETED
Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematological Malignancies
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult patients with advanced nonhematologic malignancies. This study will be the first to administer TAK 701 to hu...
Eligibility Criteria
Inclusion
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Diagnosis of a nonhematologic malignancy for which standard curative or lifeprolonging treatment does not exist or is no longer effective.
- Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study (eg, patients with pleural effusion or ascites).
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, or
- Are surgically sterile, or
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 3 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
- Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- Agree to practice effective barrier contraception during the entire study drug treatment period and through 3 months after the last dose of TAK-701, or
- Agree to completely abstain from heterosexual intercourse.
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Exclusion
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 14 days before the first dose of TAK-701 or any planned/anticipated surgery during the study period.
- Positive test for Hepatitis B or C infection.
- Active alcohol abuse
- Active infection requiring systemic therapy, or other serious infection.
- Antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any experimental therapy within 21 days before the first dose of TAK-701.
- Radiotherapy within 21 days before the first dose of TAK-701.
- Nitrosoureas or mitomycin-C within 6 weeks before the first dose of TAK-701.
- Autologous stem cell transplant within 3 months before the first dose of TAK-701, or prior allogeneic stem cell transplant at any time.
- Any prior exposure to anti-HGF therapy (eg, AMG-102, AV-299).
- The patient has symptomatic brain metastasis.
- Absolute neutrophil count \< 1,500/mm3; platelet count \< 100,000/mm3.
- Calculated creatinine clearance \< 50mL/minute
- Any of the following clinical laboratory results during screening (ie, within 28 days before the first dose of TAK-701):
- Bilirubin \> 1.5 times the upper limit of the normal range (ULN).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times the ULN. AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of metastatic disease to liver and/or to bone.
- Known human immunodeficiency virus (HIV) positive.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
- Patients having QTc \> 470 msec on a 12-lead ECG obtained within 28 days before first study drug administration.
- Presence of serious or nonhealing wound, ulcer or bone fracture.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00831896
Start Date
March 1 2009
End Date
May 1 2011
Last Update
December 2 2011
Active Locations (3)
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1
Emory University School of Medicine, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
3
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203