NCT00655655

A Phase I Trial of the mTOR Inhibitor RAD001 in Combination With VEGF Receptor Tyrosine Kinase Inhibitor PTK787/ZK 222584 in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 19 August 2024

What this trial tests

Phase 1 trial testing everolimus in Gastrinoma in 96 participants. Completed in 11 January 2018.

Timeline

1 December 2004

Primary endpoint
15 September 2009

11 January 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	96
Start date	1 December 2004
Primary completion	15 September 2009
Estimated completion	11 January 2018
Sites	1 location across United States

Drugs / interventions tested

• everolimus (everolimus) — full drug profile →
• vatalanib — full drug profile →
• pharmacological study — full drug profile →
• laboratory biomarker analysis — full drug profile →
• dynamic contrast-enhanced magnetic resonance imaging
• ultrasound imaging

Conditions studied

• Gastrinoma — all drugs for Gastrinoma →
• Glucagonoma — all drugs for Glucagonoma →
• Insulinoma — all drugs for Insulinoma →
• Metastatic Gastrointestinal Carcinoid Tumor — all drugs for Metastatic Gastrointestinal Carcinoid Tumor →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Gastrinoma or Glucagonoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Maximum tolerated dose of everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
  Time frame: Up to 28 days post treatment cycle
• Toxicity associated with everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
  Time frame: Up to 28 days post treatment cycle
• Therapeutic antitumor activity of everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
  Time frame: Up to 28 days post treatment cycle
• Recommended phase II dose (RP2D) of everolimus and vatalanib (Cohort I) (Closed to enrollment as of 12/6/06)
  Time frame: After MTD (maximum tolerate dose) is determined from Phase I
• Biological activity and therapeutic antitumor activity of everolimus and vatalanib when given at the MTD/RPTD (Cohort II)
  Time frame: Post treatment cycle
• Evaluation of pharmacogenetic, metabolic, and clinical markers that may predict hypertension induced by anti-VEGF therapy (Cohort II)
  Time frame: Day 1 and 14 of Cycle 1 of treatment

Sponsor's own description

RATIONALE: Everolimus and vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving everolimus together with vatalanib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus and vatalanib in treating patients with advanced solid tumors.

Publications & conference data

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

1. The biology and treatment of Merkel cell carcinoma: current understanding and research priorities.
   Harms PW, Harms KL, Moore PS, DeCaprio JA, et al · · 2018 · cited 234× · PMID 30287935 · DOI 10.1038/s41571-018-0103-2
2. Molecular Alterations in Thyroid Cancer: From Bench to Clinical Practice.
   Tirrò E, Martorana F, Romano C, Vitale SR, et al · · 2019 · cited 63× · PMID 31540307 · DOI 10.3390/genes10090709
3. Treatment of <i>NRAS</i>-mutated advanced or metastatic melanoma: rationale, current trials and evidence to date.
   Boespflug A, Caramel J, Dalle S, Thomas L. · · 2017 · cited 44× · PMID 28717400 · DOI 10.1177/1758834017708160
4. Activation of the IGF Axis in Thyroid Cancer: Implications for Tumorigenesis and Treatment.
   Manzella L, Massimino M, Stella S, Tirrò E, et al · · 2019 · cited 43× · PMID 31269742 · DOI 10.3390/ijms20133258
5. Metastatic Phaeochromocytoma: Spinning Towards More Promising Treatment Options.
   Nölting S, Grossman A, Pacak K. · · 2019 · cited 41× · PMID 30235495 · DOI 10.1055/a-0715-1888
6. Molecular and therapeutic advances in the diagnosis and management of malignant pheochromocytomas and paragangliomas.
   Lowery AJ, Walsh S, McDermott EW, Prichard RS. · · 2013 · cited 34× · PMID 23576482 · DOI 10.1634/theoncologist.2012-0410
7. Current research and treatment for gastrointestinal stromal tumors.
   Lim KT, Tan KY. · · 2017 · cited 31× · PMID 28785140 · DOI 10.3748/wjg.v23.i27.4856
8. Non-BRAF Mutant Melanoma: Molecular Features and Therapeutical Implications.
   Vanni I, Tanda ET, Dalmasso B, Pastorino L, et al · · 2020 · cited 29× · PMID 32850962 · DOI 10.3389/fmolb.2020.00172