Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors

A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors

This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Patupilone

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Associates in Oncology
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wertz Clinical Cancer Center (Wayne State University)
  • Missouri
    • Saint Louis, Missouri, United States, 63110-1093
      • Siteman Cancer Center (Washington University School of Medicine)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Cancer Research and Treatment Center (University of New Mexico)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin
• A minimum of 4 weeks since the last treatment with chemotherapy
• WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work)
• Age ≥ 18
• Adequate hematological parameters
• No major impairment of renal or hepatic function
• Written informed consent obtained

Exclusion criteria:

• Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery
• Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study
• Prior administration of an epothilone
• Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial
• Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the study
• Diarrhea within 7 days prior to start of treatment. Unresolved bowel obstruction
• Peripheral neuropathy > Grade 1 (mild)
• Symptomatic brain metastases
• Colostomy

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patupilone only; Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin	Drug: Patupilone
Active Comparator: Carboplatin alone; Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin	Drug: Patupilone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)	Every 3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations	Every 6 weeks
Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)	Every 6 weeks
Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response	Every 6 weeks
Pharmacokinetic profile of patupilone combined with carboplatin	First 6 weeks (cycle 1 & 2 only)
Relationship between pharmacokinetics and clinical outcome	Every 6 weeks during cycle 1 & cycle 2

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results can be found for CEPO906A2105 on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 24, 2007
• First Submitted That Met QC Criteria: January 24, 2007
• First Posted (Estimate): January 25, 2007

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Cancer; carboplatin; pharmacokinetics; maximum tolerated dose; dose-limiting toxicity; patupilone
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilone B
• Other Study ID Numbers: CEPO906A2105