NCT01537107

Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery

Completed Phase 1 Last updated 8 April 2019

What this trial tests

Phase 1 trial testing vismodegib in Acinar Cell Adenocarcinoma of the Pancreas in 31 participants. Completed in 27 June 2018.

Timeline

5 March 2012

Primary endpoint
27 June 2018

27 June 2018

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	5 March 2012
Primary completion	27 June 2018
Estimated completion	27 June 2018
Sites	3 locations across United States

Drugs / interventions tested

• vismodegib (vismodegib) — full drug profile →
• sirolimus (sirolimus) — full drug profile →
• positron emission tomography
• computed tomography
• pharmacological study — full drug profile →
• laboratory biomarker analysis
• fludeoxyglucose F 18 — full drug profile →

Conditions studied

• Acinar Cell Adenocarcinoma of the Pancreas — all drugs for Acinar Cell Adenocarcinoma of the Pancreas →
• Duct Cell Adenocarcinoma of the Pancreas — all drugs for Duct Cell Adenocarcinoma of the Pancreas →
• Recurrent Pancreatic Cancer — all drugs for Recurrent Pancreatic Cancer →
• Stage IV Pancreatic Cancer — all drugs for Stage IV Pancreatic Cancer →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Acinar Cell Adenocarcinoma of the Pancreas or Duct Cell Adenocarcinoma of the Pancreas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting Notch, Hedgehog, and Wnt pathways in cancer stem cells: clinical update.
   Takebe N, Miele L, Harris PJ, Jeong W, et al · · 2015 · cited 1034× · PMID 25850553 · DOI 10.1038/nrclinonc.2015.61
2. Therapeutic targeting of autophagy in disease: biology and pharmacology.
   Cheng Y, Ren X, Hait WN, Yang JM. · · 2013 · cited 188× · PMID 23943849 · DOI 10.1124/pr.112.007120
3. Hedgehog Signaling in Cancer: A Prospective Therapeutic Target for Eradicating Cancer Stem Cells.
   Sari IN, Phi LTH, Jun N, Wijaya YT, et al · · 2018 · cited 155× · PMID 30423843 · DOI 10.3390/cells7110208
4. Hypoxia as a barrier to immunotherapy in pancreatic adenocarcinoma.
   Daniel SK, Sullivan KM, Labadie KP, Pillarisetty VG. · · 2019 · cited 148× · PMID 30931508 · DOI 10.1186/s40169-019-0226-9
5. Cancer-associated fibroblasts in pancreatic ductal adenocarcinoma.
   Zhang T, Ren Y, Yang P, Wang J, et al · · 2022 · cited 142× · PMID 36284087 · DOI 10.1038/s41419-022-05351-1
6. Molecular pathways: novel approaches for improved therapeutic targeting of Hedgehog signaling in cancer stem cells.
   Justilien V, Fields AP. · · 2015 · cited 103× · PMID 25646180 · DOI 10.1158/1078-0432.ccr-14-0507
7. Hedgehog Signaling Pathway and Autophagy in Cancer.
   Zeng X, Ju D. · · 2018 · cited 76× · PMID 30081498 · DOI 10.3390/ijms19082279
8. Combating pancreatic cancer with PI3K pathway inhibitors in the era of personalised medicine.
   Conway JR, Herrmann D, Evans TJ, Morton JP, et al · · 2019 · cited 75× · PMID 30396902 · DOI 10.1136/gutjnl-2018-316822