ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/revert Resistance in Colorectal Cancer

Phase 2

Not yet recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: irinotecan; Drug: panitumumab; Drug: Valproic Acid (VPA)

• Registration Number: NCT06714357
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

The investigators hypothesize that the epigenetic agent valproic acid improve the activity of anti-EGFR agents, prevent and revert the emergence of EGFR resistance, in a rechallenge setting.
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Detailed Description

This study is a multicentric open label academic randomized phase-2 study. The study population will include patients with advanced or metastatic colorectal cancer, RAS/BRAF wt mCRC, eligible for a rechallenge setting (third or later line), with RAS/BRAF wt ctDNA status at study entry. A total of 130 patients (65/arm) will be required.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Study Start: 2024-12-20
• Primary Completion: 2026-12-20
• Study Completion: 2027-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STUDY PART 1 - ARM A - control arm	irinotecan	Patients will continue to receive standard rechallenge with irinotecan and panitumumab until treatment failure, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.
STUDY PART 1 - ARM A - control arm	panitumumab	Patients will continue to receive standard rechallenge with irinotecan and panitumumab until treatment failure, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.
STUDY PART 1 - ARM B - experimental arm	irinotecan	Patients will continue to receive standard rechallenge with irinotecan and panitumumab in combination with VPA until treatment failure, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.
STUDY PART 1 - ARM B - experimental arm	panitumumab	Patients will continue to receive standard rechallenge with irinotecan and panitumumab in combination with VPA until treatment failure, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.
STUDY PART 1 - ARM B - experimental arm	Valproic Acid (VPA)	Patients will continue to receive standard rechallenge with irinotecan and panitumumab in combination with VPA until treatment failure, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.

Primary Outcome Measures

Name	Time	Method
Study Part 1 - Progression Free Survival rate at 16 weeks in the two arms.	up to 16 weeks from randomization	Progression Free Survival rate at 16 weeks (PFS rate at 16-weeks) is defined as the rate of assessable patients alive and not progressed after 16 weeks from initiation of VICTORIA - Study Part 1 (i.e randomization) to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Study Part 1 - Overall survival (OS)	up to 1 year last patients randomized	Overall survival (OS) calculated as the time from randomization until the date of death from any cause. OS will be censored at the last date the patient was known to be alive for patients alive at the time of analysis.
Study Part 1: Progression free survival (PFS)	up to 1 year last patients randomized	Progression free survival (PFS) calculated as the time from randomization until the date of death from any cause until the date of the first observation of disease progression or death due to any cause, whichever occurs first. PFS will be censored at the time of the last available tumor assessment documenting absence of progressive disease for patients alive...
Study Part 1: Objective Tumor Response Rate (ORR)	up to 1 year last patients randomized	Objective Tumor Response Rate (ORR) assessed according to RECIST criteria 1.1, as the proportion of patients achieving complete or partial response relative to total enrolled patients.
Study Part 1: Disease Control Rate (DCR)	up to 1 year last patients randomized	Disease Control Rate (DCR) defined as the proportion of patients with complete/partial response and stable disease as their best response.
Study Part 1: Overall Toxicity rate	up to 1 year last patients randomized	Overall Toxicity rate defined as adverse events graded according NCI CTCAE v 5.0. as the proportion of patients experiencing any grade AE accordingly to the NCI Common Terminology Criteria of Adverse Events (NCI CTC-AE) Version 5, relative to the total of patients receiving at least one cycle of treatment.AE will be listed individually by the patient and sum...
Study Part 1 - Quality of life (QoL)	up the date of first documented progression (assessed up to 1 year)	Quality of life (QoL) investigated through the PRO-CTCAE questionnaire at baseline (prior to treatment start, once eligibility is confirmed) and every 8 weeks until disease progression, treatment failure or death.

Trial Locations

Locations (1)

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale; 🇮🇹 Napoli, Italy