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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00831896
First received: January 26, 2009
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Advanced Solid Tumors
Biological: TAK-701
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacodynamic profile, cardiac repolarization effects, antitumor activity, and recommended Phase 2 dose of TAK-701 [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TAK-701
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831896

Locations
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.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00831896     History of Changes
Other Study ID Numbers: C17001
Study First Received: January 26, 2009
Last Updated: December 1, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014