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Active Not Recruiting PHASE1 INTERVENTIONAL 1-arm NCT00878163

GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

Phase I Trial of the Combination of Vismodegib GDC-0449 and Erlotinib +/- Gemcitabine

Sponsor: National Cancer Institute (NCI)

Conditions Adult Solid Neoplasm Pancreatic Acinar Cell Carcinoma Pancreatic Ductal Adenocarcinoma Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer AJCC v6 and v7
Interventions Diagnostic Laboratory Biomarker Analysis Erlotinib Hydrochloride Gemcitabine Hydrochloride Vismodegib
Updated 40 times since 2017 Last updated: Mar 12, 2026 Started: Mar 31, 2009 Primary completion: Jan 22, 2013 Completion: Mar 6, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Adult Solid Neoplasm and Pancreatic Acinar Cell Carcinoma and is currently ongoing. National Cancer Institute (NCI) leads this study, which shows 40 recorded versions since 2009 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 with or without gemcitabine hydrochloride in patients with unresectable solid tumors. SECONDARY OBJECTIVES: I. To describe the adverse events profile associated with these treatment regimens. II. To describe the responses in patients treated with these regimens. III. To assess the effect of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 on selected biomarkers in circulating tumor cells and tumor biopsy samples from patients with metastatic pancreatic cancer. IV. To assess the effect of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 on fludeoxyglucose F 18 positron emission tomography imaging in patients with metastatic pancreatic cancer. V. To study the association between clinical (toxicity and/or tumor response or activity) and biologic (pharmacodynamic) results associated with erlotinib hydrochloride and Hedgehog antagonist GDC-0449 in patients with metastatic pancreatic cancer. OUTLINE: This is a dose-escalation study of erlotinib hydrochloride. Patients receive Hedgehog antagonist GDC-0449 orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-28. Some patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients treated at the maximum...

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 with or without gemcitabine hydrochloride in patients with unresectable solid tumors.

SECONDARY OBJECTIVES:

I. To describe the adverse events profile associated with these treatment regimens.

II. To describe the responses in patients treated with these regimens. III. To assess the effect of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 on selected biomarkers in circulating tumor cells and tumor biopsy samples from patients with metastatic pancreatic cancer.

IV. To assess the effect of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 on fludeoxyglucose F 18 positron emission tomography imaging in patients with metastatic pancreatic cancer.

V. To study the association between clinical (toxicity and/or tumor response or activity) and biologic (pharmacodynamic) results associated with erlotinib hydrochloride and Hedgehog antagonist GDC-0449 in patients with metastatic pancreatic cancer.

OUTLINE: This is a dose-escalation study of erlotinib hydrochloride.

Patients receive Hedgehog antagonist GDC-0449 orally (PO) once daily (QD) and erlotinib hydrochloride PO QD on days 1-28. Some patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients treated at the maximum tolerated dose undergo fludeoxyglucose F 18 positron emission tomography at baseline and on day 28. These patients also undergo tumor tissue and blood sample collection at baseline and periodically during study for correlative laboratory studies. Samples are analyzed for tyrosine phosphorylated or total MAP-K, EGFR, AKT, and other potential biomarkers of activity/response and for levels of genes transcriptionally activated (e.g., BCL-2, GLI, BFL-1/A1, 4-1BB, PTC1) by immunofluorescence, IHC, and quantitative-PCR.

After completion of study therapy, patients are followed at 3 months.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Jun 2018 · 10 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Jan 2019 · 5 months · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Jul 2019 · 4 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Dec 2019 · 4 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Jun 2020 · 2 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Apr 2022 · 7 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Apr 2023 · 7 months · monthly snapshot~Apr 2023 – ~Sep 2023 · 5 months · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Apr 2024 · 4 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · 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 – ~Mar 2026 · 5 months · monthly snapshot~Mar 2026 – present · 23 days · monthly snapshot

Change History

40 versions recorded

  1. Mar 2026 — Present [monthly]

    Active Not Recruiting PHASE1

  2. Oct 2025 — Mar 2026 [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 35 earlier versions

  1. Aug 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Jul 2024 — Aug 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Dec 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Nov 2023 — Dec 2023 [monthly]

    Active Not Recruiting PHASE1

  6. Oct 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

  7. Sep 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE1

  8. Apr 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE1

  9. Sep 2022 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

  10. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  11. Apr 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  12. Sep 2021 — Apr 2022 [monthly]

    Active Not Recruiting PHASE1

  13. Mar 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  14. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE1

  15. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE1

  16. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  17. Jul 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE1

  18. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1

  19. Apr 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE1

  20. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

  21. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE1

  22. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1

  23. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE1

  24. Aug 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  25. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

  26. Mar 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE1

  27. Feb 2019 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1

  28. Jan 2019 — Feb 2019 [monthly]

    Active Not Recruiting PHASE1

  29. Aug 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE1

  30. Jul 2018 — Aug 2018 [monthly]

    Active Not Recruiting PHASE1

  31. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1

  32. Aug 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  33. Jun 2017 — Aug 2017 [monthly]

    Active Not Recruiting PHASE1

  34. Feb 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE1

  35. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Mar 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

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

Study Locations