Vemurafenib, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery
A Phase I Trial of Vemurafenib in Combination With Cetuximab and Irinotecan in Patients With BRAF V600 Mutant Advanced Solid Malignancies
Sponsor: Genentech, Inc.
A PHASE1 clinical study on BRAF NP_004324.2:p.V600X and KRAS wt Allele, this trial is ongoing. The trial is conducted by Genentech, Inc. and has accumulated 20 data snapshots since 2013. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. To define the maximum tolerated dose (MTD) of vemurafenib when used in combination with cetuximab and irinotecan (irinotecan hydrochloride).
II. To define the safety profile of this combination. III. To determine the antitumor activity of this combination specifically in patients with advanced solid malignancies with positive v-raf murine sarcoma viral oncogene homolog B (BRAF) (V600)/negative Kirsten rat sarcoma viral oncogene homolog (K-RAS) mutation. (Part II-expanded cohort) IV. To determine the antitumor activity of this combination in patients with metastatic colorectal cancer with positive BRAF (V600)/negative K-RAS mutation. (Part II-expanded cohort)
SECONDARY OBJECTIVES:
I. To evaluate clinical response signals of the combination. II. To assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the combination.
OUTLINE: This is a dose-escalation study of vemurafenib.
Patients receive vemurafenib orally (PO) twice daily (BID) on days 1-14, cetuximab intravenously (IV) over 90 minutes, and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
PRIMARY OBJECTIVES:
I. To define the maximum tolerated dose (MTD) of vemurafenib when used in combination with cetuximab and irinotecan (irinotecan hydrochloride).
II. To define the safety profile of this combination. III. To determine the antitumor activity of this combination specifically in patients with advanced solid malignancies with positive v-raf murine sarcoma viral oncogene homolog B (BRAF) (V600)/negative Kirsten rat sarcoma viral oncogene homolog (K-RAS) mutation. (Part II-expanded cohort) IV. To determine the antitumor activity of this combination in patients with metastatic colorectal cancer with positive BRAF (V600)/negative K-RAS mutation. (Part II-expanded cohort)
SECONDARY OBJECTIVES:
I. To evaluate clinical response signals of the combination. II. To assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the combination.
OUTLINE: This is a dose-escalation study of vemurafenib.
Patients receive vemurafenib orally (PO) twice daily (BID) on days 1-14, cetuximab intravenously (IV) over 90 minutes, and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Status Flow
Change History
20 versions recorded-
Jan 2026 — Present [monthly]
Active Not Recruiting PHASE1
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Oct 2025 — Present [monthly]
Active Not Recruiting PHASE1
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Apr 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE1
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Oct 2024 — Apr 2025 [monthly]
Active Not Recruiting PHASE1
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Sep 2024 — Oct 2024 [monthly]
Active Not Recruiting PHASE1
▶ Show 15 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE1
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Apr 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE1
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Oct 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE1
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Sep 2022 — Oct 2023 [monthly]
Active Not Recruiting PHASE1
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Mar 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE1
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Jan 2021 — Mar 2022 [monthly]
Active Not Recruiting PHASE1
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Jun 2019 — Jan 2021 [monthly]
Active Not Recruiting PHASE1
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Oct 2018 — Jun 2019 [monthly]
Active Not Recruiting PHASE1
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Jun 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE1
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Oct 2017 — Jun 2018 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
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Aug 2017 — Oct 2017 [monthly]
Recruiting PHASE1
Status: Active Not Recruiting → Recruiting
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Jun 2017 — Aug 2017 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
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May 2017 — Jun 2017 [monthly]
Recruiting PHASE1
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Feb 2017 — May 2017 [monthly]
Recruiting PHASE1
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE1
First recorded
Feb 2013
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Genentech, Inc.
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .