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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00426582
First received: January 24, 2007
Last updated: March 24, 2011
Last verified: March 2011

January 24, 2007
March 24, 2011
August 2006
August 2010   (final data collection date for primary outcome measure)
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
Complete list of historical versions of study NCT00426582 on ClinicalTrials.gov Archive Site
  • Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
  • Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic profile of patupilone combined with carboplatin [ Time Frame: First 6 weeks (cycle 1 & 2 only) ] [ Designated as safety issue: No ]
  • Relationship between pharmacokinetics and clinical outcome [ Time Frame: Every 6 weeks during cycle 1 & cycle 2 ] [ Designated as safety issue: No ]
  • Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations
  • Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)
  • Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response
  • Pharmacokinetic profile of patupilone combined with carboplatin
  • Relationship between pharmacokinetics and clinical outcome
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: Patupilone
  • Experimental: Patupilone only
    Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin
    Intervention: Drug: Patupilone
  • Active Comparator: Carboplatin alone
    Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin
    Intervention: Drug: Patupilone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Not Provided
August 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00426582
CEPO906A2105
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP