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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

Phase 1
18 Years
Not Enrolling
Advanced Nonhematological Malignancies

Thank you

Trial Information

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

Inclusion Criteria:

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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of TAK-960 in patients with advanced nonhematologic malignancies

Outcome Description:

Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Advanced Nonhematological Malignancies
  • Neoplasms



Huntsman Cancer InstituteSalt Lake City, Utah  84112
South Texas Accelerated Research Therapeutics (START)San Antonio, Texas  78229