Dose-Escalation Study in Advanced Colon Cancer Patients

Novartis Pharmaceuticals60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colon Cancer

Interventions

EPO906 (patupilone)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Novartis Investigative Site

Hradec Králové, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Saint-Herblain, France

Novartis Investigative Site

Toulouse, France

Outcomes

Primary Outcomes

To identifymaximum tolerated dose (MTD)

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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