Phase 2
Completed N=25
Vismodegib and Gemcitabine Hydrochloride in Treating Patients With Advanced Pancreatic Cancer
Source: ClinicalTrials.gov NCT01195415 ↗Enrolled (actual)
25
Serious AEs
64.0%
Results posted
Oct 2015
Primary outcomePrimary: Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS — 4.79; 3.09 percentage of CD44+/ CD24+/ ESA+ cells
Summary
This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and gemcitabine hydrochloride may kill more tumor cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Percent at Baseline and 3 Weeks in CD44+/ CD24+/ ESA+ Cells From Needle Biopsy Calculated Using FACS |
4.79; 3.09 | — |
| SECONDARY The Number of Participants With an Objective Best Response (CR + PR) |
5 | — |
| SECONDARY Median Progression Free Survival |
2.8 | — |
| SECONDARY Percentage of Treated Patients Experiencing Grade 3+ Toxicity Per National Cancer Institute Common Toxicity Criteria (CTC) Version 3.0 |
56 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically or cytologically confirmed pancreas cancer
- Patients must have metastatic disease or recurrent disease following surgical therapy
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
- Patients must have disease accessible for core needle biopsy both prior to initiation of therapy and on day 21 (+ or - 1 day) of GDC-0449 treatment
- No previous systemic therapy for metastatic pancreas cancer is permitted; prior neoadjuvant or adjuvant therapy with chemotherapy and/or radiation is allowed provided that the last day of therapy was at least 6 months prior to registration
- Life expectancy of greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status = = 70%)
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin = grade 1 hyponatremia or hypocalcemia are excluded from this study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because GDC-0449 is a Hh pathway inhibiting agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with GDC-0449, breastfeeding should be discontinued if the mother is treated with GDC-0449; these potential risks may also apply to other agents used in this study
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with GDC-0449; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Data sourced from ClinicalTrials.gov (NCT01195415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.