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Completed

NCT Number: NCT00969046

Dose-Escalation Study in Advanced Colon Cancer Patients

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPO906 (patupilone)

Drug

Primary outcomes

  1. To identifymaximum tolerated dose (MTD)

    Time frame: During cycle 1 and 2 (approx 6 to 8 wks)

Secondary outcomes

  1. 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

    Time frame: at base line, every 3 weeks prior to start of the next dose, at end of treatment

  2. 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])

    Time frame: at baseline and every 8 wks

  3. To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration

    Time frame: Cycle 1 and 4

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Aug 31, 2009
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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