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

NCT00560963 | Completed Phase 1

• 1 other identifier: CRAD001C2491
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Advanced or Metastatic Pancreatic Adenocarcinoma

Keywords

Advanced or metastatic pancreas carcinoma; gemcitabine; everolimus

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of everolimus in combination with Gemcitabine

  8 weeks

Secondary Outcomes (1)

• 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

Study Arms (1)

1 RAD001

EXPERIMENTAL

Drug: everolimus

Interventions

everolimus DRUG

1 RAD001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases
• Adequate bone marrow, liver and renal function on everolimus treatment
• At least one measurable lesion according to RECIST criteria that has not been previously irradiated.
• 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.
• Age \>18 years

You may not qualify if:

• Women who are pregnant or breast feeding.
• Documented intolerance or history of allergy to everolimus or Gemcitabine.
• History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
• Known or symptomatic central nervous system (CNS) metastases or leptomeningeal involvement
• Chronic treatment with systemic steroids or another immunosuppressive agent
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Halle, Germany

Location

Novartis Investigative Site

Merseburg, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Oberstaufen, Germany

Location

Novartis Investigative Site

Ulm, Germany

Location

Related Links

• Results for CRAD001C2491 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 21, 2020

Record last verified: 2012-11

Locations

DE (5)