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

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

Eligibility

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:

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.

Conditions2

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