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RecruitingNCT06956248IMPACT-INSPIREUpdated May 13, 2026

Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)

An observational study in Solid Tumor, sponsored by National Cancer Centre, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by National Cancer Centre, Singapore · Observational

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
21 Years to 99 Years
Sex
All
01

Study 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. 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.

  2. 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
02

Conditions studied

  • 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
  • Translational Research
  • Patient Reported Outcomes (PROs)
  • Quality of Life (QOL)
  • Treatment Outcomes
03

In context

Lead sponsor

National Cancer Centre, Singapore is the lead sponsor of 116 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Histologic or cytologic confirmation confirmed of advanced refractory solid tumours with no further suitable treatment options.

Inclusion criteria

  1. Is equal to or greater than 21 years of age;
  2. Histologic or cytologic confirmed advanced solid tumours;
  3. 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;
  4. Ability to understand and the willingness to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Specific contraindications to exposure to the off-label or non-standard therapy (as defined by the product label);
  2. 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: Off-label or non-standard systemic therapies

Interventions

  • OtherOff-label or non-standard systemic therapies

    Off-label systemic treatments and/or relevant clinical trials recommended by the NCCS Molecular Tumour Board (MTB).

06

What researchers measure

Primary outcomes

  1. Best objective response rate at 12 weeks

    The percentage of participants with best overall response of complete response (CR) or partial response (PR).

    Time frame: Up to 12 weeks.

  2. Tumour growth rate inhibition

    Duration that patient is on experimental therapy as a fraction of the total duration on last line of therapy.

    Time frame: Up to 12 weeks.

Secondary outcomes

  1. 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.

  2. 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.

07

Study locations

1 of 1 sites recruiting
  • National Cancer Centre, Singapore
    Singapore, 168583, Singapore
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06956248
Lead sponsor
National Cancer Centre, Singapore
Collaborators
SingHealth Duke-NUS Academic Medical Centre
Responsible party
Sponsor
First posted
May 4, 2025
Start date
Sep 12, 2024
Primary completion
Sep 12, 2034 (estimated)
Completion
Mar 12, 2035 (estimated)
Last update
May 13, 2026

Study contacts

Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD
Contact
daniel.tan.s.w@singhealth.com.sg
+65 64368000
Aaron C Tan, MBBS, BSc(Med)Hons, PhD, FRACP
Contact
aaron.tan@singhealth.com.sg
+65 64368000
Daniel SW Tan, BSc(Hons), MBBS, MRCP, PhD
principal investigator · National Cancer Centre, Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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