Advanced or Metastatic Solid TumorsPhase 1NCT01014429
Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing NMS-1286937 in people with Advanced or Metastatic Solid Tumors, run by Nerviano Medical Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- NMS-1286937
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Advanced/metastatic solid tumors, for which no effective standard therapy exist
- Adult patients (age >/= 18)
- ECOG performance status (PS) 0 or 1
- Life expectancy of at least 3 months
- Adequate renal, liver function and bone marrow reserve
- Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade </=1
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- Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
- Women and men of child producing potential should agree to use effective contraception
- Capability to swallow capsules intact
Who cannot join
- Known uncontrolled/symptomatic brain metastases
- Currently active second malignancy
- Major surgery in the last 4 wks
- Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- Pregnancy or breast-feeding women
- Known active infections
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- History of drug allergic reactions
- Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption.
- Documented gastrointestinal ulcer
- Other severe concurrent acute or chronic medical or psychiatric condition that could compromise protocol objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona TGen Clinical Research Services at Scottsdale Heathcare
Scottsdale, Arizona, 85258
About this study
Official title: A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- NMS-1286937
- Keywords
- Phase I dose escalation study, Advanced or metastatic solid tumors, PLK 1 inhibitor, Adult patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMS-1286937Drug
Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: NMS-1286937 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
Measured: Cycle 1
Secondary outcomes (2)
Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)
Measured: Cycles 1 and 2
Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients
Measured: Cycles 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariangela Mariani, Biol Sci D, Study director, Nerviano Medical SciencesMaria Adele Pacciarini, Biol Sci D, Study director, Nerviano Medical SciencesGlen J Weiss, MD, Principal investigator, Arizona TGen Clinical Reserch Services at Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014429
- Sponsor's protocol ID
- PLKA-937-001
- Status last verified
- Sep 2012
- First submitted
- 16 Nov 2009
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of NMS-1286937 Administered to Adult Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01014429
- Acronym / sponsor ID
- PLKA-937-001
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- Phase I dose escalation study, Advanced or metastatic solid tumors, PLK 1 inhibitor, Adult patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nerviano Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NMS-1286937 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced/metastatic solid tumors, for which no effective standard therapy exist
- Adult patients (age >/= 18)
- ECOG performance status (PS) 0 or 1
- Life expectancy of at least 3 months
- Adequate renal, liver function and bone marrow reserve
Key exclusion criteria (10 listed)
- Known uncontrolled/symptomatic brain metastases
- Currently active second malignancy
- Major surgery in the last 4 wks
- Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
- Pregnancy or breast-feeding women
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 |
|---|---|---|
| NMS-1286937Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops. | Drug | 1 |
Primary outcome
Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)
Time frame: Cycle 1
2 secondary outcomes
Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)
Time frame: Cycles 1 and 2
Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients
Time frame: Cycles 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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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.
Mariangela Mariani, Biol Sci D study director
Nerviano Medical Sciences
Maria Adele Pacciarini, Biol Sci D study director
Nerviano Medical Sciences
Glen J Weiss, MD principal investigator
Arizona TGen Clinical Reserch Services at Scottsdale Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NMS-1286937 in people with Advanced or Metastatic Solid Tumors, run by Nerviano Medical Sciences at 1 site 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 first cycle dose limiting toxicities (DLTs) (time frame: Cycle 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2012.