Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematological Malignancies

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: NCT00831896
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : December 2, 2011
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

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 humans. The primary purpose of this study is to determine the safety profile, tolerability, and pharmacokinetics profile of TAK-701.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: TAK-701 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Dose Escalation Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematologic Malignancies
Study Start Date : March 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: 1
Biological: TAK-701

Either 2, 5, 10, or 20 mg/kg IV. Cycle 1: single dose at 2x the dose assignment; Cycle 2 and beyond: dose once every two weeks

Dosing continues until disease progression, unacceptable toxicity related to TAK-701, or maximum of 12 cycles, unless determined that patient would benefit from continued therapy.

Primary Outcome Measures :
  1. Safety profile (adverse events including dose limiting toxicities, clinical safety assessments such as human antihumanized antibody (HAHA) and neutr. HAHA), tolerability (maximum tolerated dose or maximum feasible dose), and pharmacokinetic profile. [ Time Frame: Duration of study ]

Secondary Outcome Measures :
  1. Pharmacodynamic profile, cardiac repolarization effects, antitumor activity, and recommended Phase 2 dose of TAK-701 [ Time Frame: Duration of study ]
  2. Investigator's assessment of disease response using Response Evaluation Criteria in Solid Tumors guidelines and relevant tumor markers in serum such as PSA, CA 125 and CA 19-9 [ Time Frame: Duration of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients aged 18 years or older.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  3. Diagnosis of a nonhematologic malignancy for which standard curative or lifeprolonging treatment does not exist or is no longer effective.
  4. Radiographically or clinically evaluable tumor; however, measurable disease is not required for participation in this study (eg, patients with pleural effusion or ascites).
  5. 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.
  6. 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 Criteria:

  1. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
  2. Major surgery within 14 days before the first dose of TAK-701 or any planned/anticipated surgery during the study period.
  3. Positive test for Hepatitis B or C infection.
  4. Active alcohol abuse
  5. Active infection requiring systemic therapy, or other serious infection.
  6. Antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any experimental therapy within 21 days before the first dose of TAK-701.
  7. Radiotherapy within 21 days before the first dose of TAK-701.
  8. Nitrosoureas or mitomycin-C within 6 weeks before the first dose of TAK-701.
  9. Autologous stem cell transplant within 3 months before the first dose of TAK-701, or prior allogeneic stem cell transplant at any time.
  10. Any prior exposure to anti-HGF therapy (eg, AMG-102, AV-299).
  11. The patient has symptomatic brain metastasis.
  12. Absolute neutrophil count < 1,500/mm3; platelet count < 100,000/mm3.
  13. Calculated creatinine clearance < 50mL/minute
  14. 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.
  15. Known human immunodeficiency virus (HIV) positive.
  16. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  17. Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
  18. Patients having QTc > 470 msec on a 12-lead ECG obtained within 28 days before first study drug administration.
  19. Presence of serious or nonhealing wound, ulcer or bone fracture.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00831896

United States, Georgia
Emory University School of Medicine, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT00831896     History of Changes
Other Study ID Numbers: C17001
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: December 2011