MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01) (C-PRECISE-01)
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|ClinicalTrials.gov Identifier: NCT04495621|
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: MEN1611 Drug: Cetuximab||Phase 1 Phase 2|
This Phase Ib/II study will investigate the anti-tumour activity and safety of daily oral doses MEN1611 in combination with cetuximab in female and male patients affected by PIK3CA mutated, N-K-RAS wild-type and BRAF wild-type metastatic colorectal cancer.
MEN1611 is a potent, selective Class I phosphoinositide 3-kinase (PI3K) inhibitor. The Maximum Tolerated Dose (MTD) of MEN1611 given as single agent was assessed in a phase I trial in patients with advanced solid tumors.
This Phase Ib/II will start with a dose confirmation part (Step 1) to identify the RP2D of MEN1611 given in combination with cetuximab.
The study will continue with a cohort expansion (Step 2) to explore the anti-tumour activity of the selected MEN1611 dose level combined with cetuximab with further assessment of their safety and tolerability.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Step 1: Confirmation of Dose for Cohort Expansion / Step 2: Cohort Expansion|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens|
|Actual Study Start Date :||July 20, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
MEN1611 + Cetuximab
MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
Cetuximab solution for infusion administered weekly via IV infusion.
- Determination of recommended phase II dose (RP2D) [ Time Frame: 28 Days ]Determination of the recommended phase II dose of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
- Best overall response rate (ORR) according to RECIST v.1.1 [ Time Frame: 36 Months ]Assessment of the anti-tumour activity of MEN1611 in combination with cetuximab in patients with PIK3CA mutated metastatic colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
- Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 36 Months ]Assessment of the tolerability of MEN1611 in combination with cetuximab according to NCI CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495621
|Contact: Angela Capriati - Corporate Director, PhD MD||+390555680 ext email@example.com|
|Contact: Serena Buontempo - Clinical Research Physician, MD||+390555680 ext firstname.lastname@example.org|
|Study Chair:||Josep Tabernero, PhD MD||Vall d' Hebron Institute of Oncology (VHIO), Barcelona, Spain|