Dose-Escalation Study in Advanced Colon Cancer Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00969046

Enrollment

Registered

2009-08-31

Start date

2003-11-30

Completion date

2006-11-30

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Colon cancer, MTD, DLT, EPO906, patupilone

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.

Interventions

DRUGEPO906 (patupilone)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Czechia, France, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026