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OpenTrials
Completed

NCT Number: NCT00426582

Combination Trial of Patupilone and Carboplatin 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Norwalk Hospital, Norwalk, Connecticut, United States

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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 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

Treatment and study plan

Patupilone

Drug

Primary outcomes

  1. Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)

    Time frame: Every 3 weeks

Secondary outcomes

  1. Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations

    Time frame: Every 6 weeks

  2. Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)

    Time frame: Every 6 weeks

  3. Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response

    Time frame: Every 6 weeks

  4. Pharmacokinetic profile of patupilone combined with carboplatin

    Time frame: First 6 weeks (cycle 1 & 2 only)

  5. Relationship between pharmacokinetics and clinical outcome

    Time frame: Every 6 weeks during cycle 1 & cycle 2

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
First posted
Jan 25, 2007
Registry last updated
Dec 9, 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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