Dose-Escalation Study in Advanced Colon Cancer Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Colon Cancer

Treatments: Drug: EPO906 (patupilone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969046

CEPO906A2117

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Bolus

Experimental group

Description:

20 min bolus infusion

Treatment:

Drug: EPO906 (patupilone)

CIV-1d

Experimental group

Description:

1 day continuous infusion

Treatment:

Drug: EPO906 (patupilone)

CIV-5d

Experimental group

Description:

5 day continuous infusion

Treatment:

Drug: EPO906 (patupilone)