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

Millennium Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Advanced Nonhematological Malignancies

Treatments

Drug: TAK-960

Study type

Interventional

Funder types

Industry

Identifiers

NCT01179399

C22001

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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