Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

Combination of Antiangiogenic Therapy Using the mTOR-inhibitor RAD001 and Low Dose Chemotherapy for Locally Advanced and/or Metastatic Pancreatic Cancer - a Dose Finding Study

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560963

Enrollment

Registered

2007-11-20

Start date

2007-10-31

Completion date

2011-01-31

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Pancreatic Adenocarcinoma

Keywords

Advanced or metastatic pancreas carcinoma, gemcitabine, everolimus

Brief summary

A dose finding study in locally advanced and/or metastatic pancreatic cancer patients

Interventions

DRUGeverolimus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases 2. Adequate bone marrow, liver and renal function on everolimus treatment 3. At least one measurable lesion according to RECIST criteria that has not been previously irradiated. 4. Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer. 5. Age \>18 years

Exclusion criteria

1. Women who are pregnant or breast feeding. 2. Documented intolerance or history of allergy to everolimus or Gemcitabine. 3. History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer 4. Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement 5. Chronic treatment with systemic steroids or another immunosuppressive agent 6. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus 7. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin). Quick-value \< 50 % or prothrombine time more than 1,5 fold higher Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine	8 weeks

Secondary

Measure	Time frame
Safety & tolerability, pharmacokinetic assessments of Everolimus and Gemcitabine combination therapy in these patient populations. Phase II objective response rates (ORR), duration of response, progression-free survival (PFS), overall survival (OS)	36 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026