Advanced Nonhematological MalignanciesPhase 1NCT01179399

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

A Phase 1 study testing TAK-960 in people with Advanced Nonhematological Malignancies, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Nonhematological Malignancies
What is being tested?: TAK-960
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: Sep 2010to Jan 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Advanced Nonhematological Malignancies
Being tested: TAK-960

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-960Drug
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.

Study groups in NCT01179399
Study group	Role	What they receive
TAK-960	Experimental	Not described Receives: Drug: TAK-960

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960
Adverse events, serious adverse events, assessments of clinical laboratory values, vital sign measurements and electrocardiograms (ECGs)
Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Jan 2013

First posted11 Aug 2010 (estimated)
Study startSep 2010
Primary completionOct 2012
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Nonhematological MalignanciesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01179399
Sponsor's protocol ID: C22001
Status last verified: Jan 2014
First submitted: 9 Aug 2010
Last updated: 3 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01179399
Acronym / sponsor ID: C22001
Conditions: Advanced Nonhematological Malignancies
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 32 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Oct 2012 (actual)
Study completion: Jan 2013 (actual)
First posted: 11 Aug 2010 (estimated)
Results: Posted 3 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAK-960	Experimental	Drug: TAK-960

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-960TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.	Drug	TAK-960

Primary outcome

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)

Results and safety

Results posted to the registry on 3 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-960	32	0

Primary outcome: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960

Time frame: up to 12 months

Population analysed: Maximum tolerable dose (MTD) and recommended phase 2 dose (RP2D) of TAK-960 were not determined due to sponsor decision to discontinue the study for business reasons.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-960	13 of 32 (40.6%)	31 of 32 (96.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-960 in people with Advanced Nonhematological Malignancies, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960 (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01179399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014.