Solid TumorIMPACT-INSPIRENCT06956248
Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)
An observational study of Solid Tumor, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board. 1. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Off-label or non-standard systemic therapies
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Sep 2024to 12 Mar 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologic or cytologic confirmation confirmed of advanced refractory solid tumours with no further suitable treatment options.
Who may be able to join
- Is equal to or greater than 21 years of age;
- Histologic or cytologic confirmed advanced solid tumours;
- Patients who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
- Ability to understand and the willingness to provide written informed consent.
Who cannot join
- Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label);
- Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre, Singapore
Singapore, 168583
Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD, +65 64368000, daniel.tan.s.w@singhealth.com.sg
About this study
This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board.
- To standardize response assessment and data collection for patients that are receiving off-label or non-standard therapies based on MTB recommendations.
Read more
- Establish a standardized response assessment process and data collection patients that are receiving off-label or non-standard therapies based on MTB recommendations.
- To demonstrate that it is feasible to standardize investigations and endpoints in this proof-of-concept study.
- Through standard safety laboratory investigations (FBC, U/E/Cr, LFT)
- Through standard radiological imaging at 6-12 weeks with the key endpoint being best response during that imaging window, and disease control rate at 6 months.
Hypothesis: Our proposed IMPACT-INSPIRE study hypothesis is that standardised response assessment and data collection in patients with no available therapies receiving off-label systemic therapies, can provide a novel mechanism to assess oncological outcomes in this unique cohort of patients, generate hypothesis, and provide insights to future biomarker-driven drug development
Read the detailed description
The patient will be observed clinically after informed consent has been obtained. Patients may require more frequent assessment or additional procedures as clinically necessary or as required by the product label.
- Each participant will have undergone comprehensive molecular profiling with results discussed at NCCS molecular tumour board. Where necessary, orthogonal studies/assays may be performed.
- The molecular profiling results will be provided by the referring physician and primary investigator/co-investigator (PI/Co-I). All cases will be presented in the NCCS Molecular Tumour Board (MTB) where there is an adequate quorum of participating members.
- The MTB will analyse the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions.
- The subsequent treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.
- Translational tissue and plasma may be additionally collected at various timepoints during the study for correlational translational research
- Conditions
- Solid Tumor
- Being tested
- Off-label or non-standard systemic therapies
- Keywords
- Advanced Cancers, Solid Tumours, Off-label Cancer Therapies, Non-standard Cancer Therapies, Molecular Tumour Board (MTB), Response Assessment, Real-World Data Collection, Precision Oncology, Translational Research, Patient Reported Outcomes (PROs), Quality of Life (QOL), Treatment Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-label or non-standard systemic therapiesOther
Off-label systemic treatments and/or relevant clinical trials recommended by the NCCS Molecular Tumour Board (MTB).
| Study group | Role | What they receive |
|---|---|---|
| Study population with histologic or cytologic confirmed advanced solid tumours | Histologic or cytologic confirmed advanced treatment refractory solid tumours with no further suitable standard treatment options. Receives: Other: Off-label or non-standard systemic therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best objective response rate at 12 weeks
The percentage of participants with best overall response of complete response (CR) or partial response (PR).
Measured: Up to 12 weeks.
Tumour growth rate inhibition
Duration that patient is on experimental therapy as a fraction of the total duration on last line of therapy.
Measured: Up to 12 weeks.
Secondary outcomes (2)
Incidence of adverse events (AEs), Identified and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria.
Measured: From the initiation of protocol therapy, up to 30 days after last dose of off-label or non-standard therapy.
Quality of life thorough AE evaluation or equivalent instruments such as the EORTC QLQ-C30 questionnaire.
Measured: Baseline and after every 2 cycles till end of treatment, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start12 Sep 2024
- Primary completion12 Sep 2034 (estimated)
- Study completion12 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Duke-NUS Academic Medical Centre
- Responsible party
- Sponsor
- Investigators
- Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956248
- Sponsor's protocol ID
- 2024/3309
- Acronym
- IMPACT-INSPIRE
- Status last verified
- May 2026
- First submitted
- 30 Apr 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)
- ClinicalTrials.gov ID
- NCT06956248
- Acronym / sponsor ID
- IMPACT-INSPIRE / 2024/3309
- Conditions
- Solid Tumor
- Keywords
- Advanced Cancers, Solid Tumours, Off-label Cancer Therapies, Non-standard Cancer Therapies, Molecular Tumour Board (MTB), Response Assessment, Real-World Data Collection, Precision Oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- SingHealth Duke-NUS Academic Medical Centre
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 12 Sep 2034 (estimated)
- Study completion
- 12 Mar 2035 (estimated)
- First posted
- 4 May 2025 (actual)
- 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.
This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board.
- To standardize response assessment and data collection for patients that are receiving off-label or non-standard therapies based on MTB recommendations.
- Establish a standardized response assessment process and data collection patients that are receiving off-label or non-standard therapies based on MTB recommendations.
- To demonstrate that it is feasible to standardize investigations and endpoints in this proof-of-concept study.
- Through standard safety laboratory investigations (FBC, U/E/Cr, LFT)
- Through standard radiological imaging at 6-12 weeks with the key endpoint being best response during that imaging window, and disease control rate at 6 months.
Hypothesis: Our proposed IMPACT-INSPIRE study hypothesis is that standardised response assessment and data collection in patients with no available therapies receiving off-label systemic therapies, can provide a novel mechanism to assess oncological outcomes in this unique cohort of patients, generate hypothesis, and provide insights to future biomarker-driven drug development
Detailed description
The patient will be observed clinically after informed consent has been obtained. Patients may require more frequent assessment or additional procedures as clinically necessary or as required by the product label.
- Each participant will have undergone comprehensive molecular profiling with results discussed at NCCS molecular tumour board. Where necessary, orthogonal studies/assays may be performed.
- The molecular profiling results will be provided by the referring physician and primary investigator/co-investigator (PI/Co-I). All cases will be presented in the NCCS Molecular Tumour Board (MTB) where there is an adequate quorum of participating members.
- The MTB will analyse the findings and provide a written report to the treating physician on recommended treatments and/or relevant clinical trials; the treating physician makes all treatment decisions.
- The subsequent treatments and treatment responses will be tracked longitudinally during the term of this study, thus linking molecularly informed treatments to specific patient outcomes.
- Translational tissue and plasma may be additionally collected at various timepoints during the study for correlational translational research
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population with histologic or cytologic confirmed advanced solid tumours | – | Other: Off-label or non-standard systemic therapiesHistologic or cytologic confirmed advanced treatment refractory solid tumours with no further suitable standard treatment options. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologic or cytologic confirmation confirmed of advanced refractory solid tumours with no further suitable treatment options.
Key inclusion criteria (4 listed)
- Is equal to or greater than 21 years of age;
- Histologic or cytologic confirmed advanced solid tumours;
- Patients who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
- Ability to understand and the willingness to provide written informed consent.
Key exclusion criteria (2 listed)
- Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label);
- Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the 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 |
|---|---|---|
| Off-label or non-standard systemic therapiesOff-label systemic treatments and/or relevant clinical trials recommended by the NCCS Molecular Tumour Board (MTB). | Other | Study population with histologic or cytologic confirmed advanced solid tumours |
Primary outcome
Best objective response rate at 12 weeks
Time frame: Up to 12 weeks.
The percentage of participants with best overall response of complete response (CR) or partial response (PR).
Tumour growth rate inhibition
Time frame: Up to 12 weeks.
Duration that patient is on experimental therapy as a fraction of the total duration on last line of therapy.
2 secondary outcomes
Incidence of adverse events (AEs), Identified and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 criteria.
Time frame: From the initiation of protocol therapy, up to 30 days after last dose of off-label or non-standard therapy.
Quality of life thorough AE evaluation or equivalent instruments such as the EORTC QLQ-C30 questionnaire.
Time frame: Baseline and after every 2 cycles till end of treatment, up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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 Singapore. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD (+65 64368000, daniel.tan.s.w@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best objective response rate at 12 weeks (time frame: Up to 12 weeks.). The study lists 2 primary outcomes in all. 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 13 May 2026.