Dose-Escalation Study in Advanced Colon Cancer Patients

Phase 1

Completed

• Conditions: Colon Cancer
• Interventions: Drug: EPO906 (patupilone)

• Registration Number: NCT00969046
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-31
• Status Verified: 2016-04
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIV-1d	EPO906 (patupilone)	1 day continuous infusion
CIV-5d	EPO906 (patupilone)	5 day continuous infusion
Bolus	EPO906 (patupilone)	20 min bolus infusion

Primary Outcome Measures

Name	Time	Method
To identifymaximum tolerated dose (MTD)	During cycle 1 and 2 (approx 6 to 8 wks)

Secondary Outcome Measures

Name	Time	Method
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
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
To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration	Cycle 1 and 4

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 London, United Kingdom