Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01179399
First received: August 9, 2010
Last updated: January 13, 2014
Last verified: January 2014

August 9, 2010
January 13, 2014
September 2010
October 2012   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960 [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
  • To identify the maximum tolerated dose (MTD) and inform the recommended phase 2 dose (RP2D) of TAK-960 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
  • To evaluate the safety and tolerability of TAK-960 in patients with advanced nonhematologic malignancies [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
Complete list of historical versions of study NCT01179399 on ClinicalTrials.gov Archive Site
Not Provided
  • To characterize the pharmacokinetics (PK) of TAK-960 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate the antitumor activity that may be observed with TAK-960 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To evaluate the pharmacodynamics of TAK-960 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by direct and distal pathway biomarkers
  • To determine any TAK-960-associated changes in tumor metabolism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies
A Phase 1, Open-Label, Dose-Escalation Study of Orally Administered TAK-960, a Polo-Like Kinase 1 Inhibitor, in Patients With Advanced Nonhematologic Malignancies

Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This study will be the first to administer TAK-960 to humans. The patient population will consist of adults with a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential, or for which no standard treatment is available.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Nonhematological Malignancies
Drug: TAK-960
TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.
Experimental: TAK-960
Intervention: Drug: TAK-960
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
January 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • Male or female 18 years or older
  • Clinical laboratory values as specified in protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically and/or cytologically confirmed diagnosis of metastatic, unresectable, advanced evaluable nonhematologic malignancy for which standard treatment is not available or no longer effective
  • Radiographically or clinically evaluable tumor
  • Suitable venous access for study-required blood sampling
  • Female patients who are postmenopausal, surgically sterile or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
  • Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
  • Voluntary written consent
  • Willing to undergo biopsy procedures (expansion phase only)
  • Weight at least 40 kg
  • Recovered from the reversible effects of prior antineoplastic therapy to Grade ≤ 1 or to patient's baseline values, excluding alopecia

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Diagnosis of primary central nervous system malignancy or carcinomatous meningitis
  • Patient has symptomatic brain metastasis. Patients with brain metastases must: have stable neurologic status for at least 2 weeks following completion of local therapy AND be without neurologic dysfunction that would confound the evaluation of adverse events
  • Prior allogeneic bone marrow or stem cell transplant
  • Prior therapy or treatment as specified in protocol
  • Female patients who are lactating or who have a positive serum pregnancy test during the screening period of within 3 days before the first dose of TAK-960
  • Myocardial infarction within 6 months before first dose of TAK-960
  • Any of the cardiovascular conditions or values as specified in the study protocol within 6 months before the first dose of TAK-960
  • Infection requiring systemic anti-infective therapy within 14 days before the start of TAK-960, or other severe infection
  • Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive or known suspected active hepatitis C infection
  • A diagnosis of or treated for another malignancy within 2 years before the first dose of TAK-960 or previous diagnosis of another malignancy and any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection
  • Any serious medical or psychiatric illness that could potentially interfere with the completion of treatment
  • Recurrent nausea or vomiting or requirement for antiemetic therapy within 14 days before the first dose of TAK-960
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerability of TAK-960, including difficulty swallowing capsules
  • Treatment with any investigational products within 21 days before the first dose of TAK-960
  • Systemic use of strong CYP3A inhibitors or inducers within 14 days before the first dose of TAK-960
  • Patients enrolled in the expansion cohorts where tumor biopsies are required must meet additional criteria according to the study protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01179399
C22001
No
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP