Dose-Escalation Study in Advanced Colon Cancer Patients

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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

  • 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
  • Age ≥ 18 years
  • Life expectancy ≥ 12 weeks
  • WHO performance status of 0-1
  • Negative serum pregnancy test
  • Adequate hepatic or renal function and hematological parameters

Exclusion criteria

  • Brain metastases
  • Ileostomy or colonostomy
  • History of pelvic radiotherapy
  • 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)

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)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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