deltatrials
Active Not Recruiting PHASE1 INTERVENTIONAL 1-arm NCT01787500

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.

Updated 20 times since 2017 Last updated: Sep 5, 2025 Started: Feb 15, 2013 Primary completion: Mar 31, 2026 Completion: Mar 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Jun 2019 · 8 months · monthly snapshot~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshot~Jan 2021 – ~Mar 2022 · 14 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Oct 2023 · 13 months · monthly snapshot~Oct 2023 – ~Apr 2024 · 6 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Apr 2025 · 6 months · monthly snapshot~Apr 2025 – ~Oct 2025 · 6 months · monthly snapshot~Oct 2025 – present · 6 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

20 versions recorded
  1. Jan 2026 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE1

  3. Apr 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Oct 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2024 — Oct 2024 [monthly]

    Active Not Recruiting PHASE1

Show 15 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Oct 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Sep 2022 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

  5. Mar 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  6. Jan 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE1

  7. Jun 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  8. Oct 2018 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

  9. Jun 2018 — Oct 2018 [monthly]

    Active Not Recruiting PHASE1

  10. Oct 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  11. Aug 2017 — Oct 2017 [monthly]

    Recruiting PHASE1

    Status: Active Not RecruitingRecruiting

  12. Jun 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE1

    Status: RecruitingActive Not Recruiting

  13. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE1

  14. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE1

  15. 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

Sponsor contact:
  • Genentech, Inc.
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: M.D. Anderson Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations