- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01179399
Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies
January 13, 2014 updated by: Millennium Pharmaceuticals, Inc.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- South Texas Accelerated Research Therapeutics (START)
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960
Time Frame: up to 12 months
|
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (ACTUAL)
October 1, 2012
Study Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
August 9, 2010
First Submitted That Met QC Criteria
August 9, 2010
First Posted (ESTIMATE)
August 11, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 3, 2014
Last Update Submitted That Met QC Criteria
January 13, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C22001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Nonhematological Malignancies
-
Calithera Biosciences, IncTerminatedAdvanced Nonhematological NeoplasmsKorea, Republic of, Japan, Taiwan
-
Amsterdam UMC, location VUmcCompletedColorectum Advanced Malignancies | Breast Advanced Malignancies | Prostate Advanced MalignanciesNetherlands
-
AHS Cancer Control AlbertaCross Cancer InstituteWithdrawnMetastatic Solid Malignancies | Locally Advanced Solid MalignanciesCanada
-
Shandong New Time Pharmaceutical Co., LTDFudan University; Shanghai General Hospital, Shanghai Jiao Tong University...Not yet recruitingAdvanced Malignancies
-
Zhe Jiang Hisun Bioray Bio-pharmaceu tical Co.LtdNot yet recruitingAdvanced MalignanciesChina
-
Innovent Biologics (Suzhou) Co. Ltd.Recruiting
-
BioInvent International ABMerck Sharp & Dohme LLCRecruitingAdvanced MalignanciesUnited Kingdom, Denmark, Hungary, Russian Federation
-
Innovent Biologics (Suzhou) Co. Ltd.CompletedAdvanced MalignanciesChina
-
Jiangsu HengRui Medicine Co., Ltd.CompletedAdvanced MalignanciesAustralia, China
-
Innovent Biologics (Suzhou) Co. Ltd.CompletedAdvanced MalignanciesChina
Clinical Trials on TAK-960
-
University Hospital, LinkoepingSahlgrenska University Hospital, Sweden; University Hospital, Umeå; Region Örebro...CompletedHeart Failure | Postoperative Complications | Coronary Artery Bypass SurgerySweden
-
TakedaWithdrawn
-
TakedaTerminatedAttention-Deficit/Hyperactivity DisorderUnited States
-
TakedaTerminatedCardiovascular Disease | Type 2 DiabetesUnited States, France, Poland, Ukraine, Germany, Hong Kong, Taiwan, Argentina, Israel, Mexico, Bulgaria, Malaysia, Romania, Canada, Korea, Republic of, New Zealand, Peru, Estonia, Philippines, Russian Federation, Czech Republic, H... and more
-
TakedaCompletedHealthyUnited Kingdom
-
Neurocrine BiosciencesTakedaTerminatedSchizophrenia, Cerebellar AtaxiaUnited Kingdom