Dose-Escalation Study in Advanced Colon Cancer Patients

Colon Cancer Clinical Trial

Official title:

EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969046
• Other study ID #: CEPO906A2117
• Status: Completed
• Phase: Phase 1
• Start date: November 2003
• Est. completion date: November 2006

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST

2. Age = 18 years

3. Life expectancy = 12 weeks

4. WHO performance status of 0-1

5. Negative serum pregnancy test

6. Adequate hepatic or renal function and hematological parameters

Exclusion Criteria:

1. Brain metastases

2. Ileostomy or colonostomy

3. History of pelvic radiotherapy

4. Grade > 1 diarrhea at baseline

Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• EPO906 (patupilone)

Locations

Country	Name	City	State
Czechia	Novartis Investigative Site	Hradec Králové
Czechia	Novartis Investigative Site	Prague
France	Novartis Investigative Site	Saint-Herblain Cedex
France	Novartis Investigative Site	Toulouse
Spain	Novartis Investigative Site	Barcelona
United Kingdom	Novartis Investigative Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Czechia,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identifymaximum tolerated dose (MTD)		During cycle 1 and 2 (approx 6 to 8 wks)
Secondary	To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams		at base line, every 3 weeks prior to start of the next dose, at end of treatment
Secondary	To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST])		at baseline and every 8 wks
Secondary	To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration		Cycle 1 and 4

External Links

•   Results for CEPO906A2117 can be found on the Novartis Clinical Trial Results Website