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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426582
First Posted: January 25, 2007
Last Update Posted: March 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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

Condition Intervention Phase
Advanced Solid Tumors Drug: Patupilone Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) [ Time Frame: Every 3 weeks ]

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

Enrollment: 48
Study Start Date: August 2006
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426582


Locations
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Maryland
Associates in Oncology
Rockville, Maryland, United States, 20850
United States, Michigan
Wertz Clinical Cancer Center (Wayne State University)
Detroit, Michigan, United States, 48201
United States, Missouri
Siteman Cancer Center (Washington University School of Medicine)
St. Louis, Missouri, United States, 63110-1093
United States, New Mexico
Cancer Research and Treatment Center (University of New Mexico)
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00426582     History of Changes
Other Study ID Numbers: CEPO906A2105
First Submitted: January 24, 2007
First Posted: January 25, 2007
Last Update Posted: March 25, 2011
Last Verified: March 2011

Keywords provided by Novartis:
Cancer
maximum tolerated dose
dose-limiting toxicity
patupilone
carboplatin
pharmacokinetics

Additional relevant MeSH terms:
Epothilone B
Carboplatin
Epothilones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action