Advanced/Metastatic Solid TumorsPhase 1NCT01092052
Study of NMS-1116354 in Advanced/Metastatic Solid Tumors
A Phase 1 study testing NMS-1116354 in people with Advanced/Metastatic Solid Tumors, run by Nerviano Medical Sciences at 1 site in France.
Trial summary
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced/Metastatic Solid Tumors
- What is being tested?
- NMS-1116354
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jul 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
- Maximum of 4 regimens of prior cancer therapy allowed
- Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
- Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
- ECOG performance status (PS) 0 or 1
- Adult (age >/= 18 and </= 80 years) patients
- Adequate renal, liver and BM reserve
- Capability to swallow capsules intact
Who cannot join
- Current enrollment in another therapeutic clinical trial
- Known brain metastases
- Currently active second malignancy
- Major surgery within 4 weeks prior to treatment
- 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
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- Known active infections
- Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
- Adrenal insufficiency
- Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose-Escalation Study of NMS-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors
The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.
- Conditions
- Advanced/Metastatic Solid Tumors
- Being tested
- NMS-1116354
- Keywords
- Phase I study, Advanced/Metastatic Solid Tumors, Cdc7 kinase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMS-1116354Drug
Oral daily administration for 14 consecutive days followed by 7 days of rest
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: NMS-1116354 |
What is being measured
The primary outcome is the main question the study is designed to answer.
First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)
Measured: 3 weeks
Secondary outcomes (1)
Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
Why it stopped: Discontinuation of clinical investigation with NMS-1116354
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced/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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nerviano Medical Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Soria, MD, Principal investigator, Institut Gustave-Roussy (IGR)Stefania Crippa, Biotech D, PhD, Study director, Nerviano Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092052
- Sponsor's protocol ID
- CDCA-354-002
- Status last verified
- Sep 2012
- First submitted
- 22 Mar 2010
- 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-1116354 in Adult Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01092052
- Acronym / sponsor ID
- CDCA-354-002
- Conditions
- Advanced/Metastatic Solid Tumors
- Keywords
- Phase I study, Advanced/Metastatic Solid Tumors, Cdc7 kinase inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of clinical investigation with NMS-1116354
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nerviano Medical SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- First posted
- 24 Mar 2010 (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 profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.
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-1116354 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
- Maximum of 4 regimens of prior cancer therapy allowed
- Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
- Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
- ECOG performance status (PS) 0 or 1
Key exclusion criteria (10 listed)
- Current enrollment in another therapeutic clinical trial
- Known brain metastases
- Currently active second malignancy
- Major surgery within 4 weeks prior to treatment
- 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
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-1116354Oral daily administration for 14 consecutive days followed by 7 days of rest | Drug | 1 |
Primary outcome
First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD)
Time frame: 3 weeks
1 secondary outcome
Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), time of occurence of Cmax (tmax) and half-life (t½)
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Discontinuation of clinical investigation with NMS-1116354). Results are not available in the source record.
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.
Jean-Charles Soria, MD principal investigator
Institut Gustave-Roussy (IGR)
Stefania Crippa, Biotech D, PhD study director
Nerviano Medical Sciences
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-1116354 in people with Advanced/Metastatic Solid Tumors, run by Nerviano Medical Sciences at 1 site in France.
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 8 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: stopped early, 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 France. 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 was stopped early (reason given: Discontinuation of clinical investigation with NMS-1116354). Results are not available in the source record.
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?
First cycle dose-limiting toxicities (DLTs) and related maximum tolerated dose(MTD) (time frame: 3 weeks). 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.