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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Every 3 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2105

NCT ID:

NCT00426582

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Cancer
  • maximum tolerated dose
  • dose-limiting toxicity
  • patupilone
  • carboplatin
  • pharmacokinetics
  • Neoplasms

Name

Location

Norwalk HospitalNorwalk, Connecticut  06856
Associates in OncologyRockville, Maryland  20850
Wertz Clinical Cancer Center (Wayne State University)Detroit, Michigan  48201
Siteman Cancer Center (Washington University School of Medicine)St. Louis, Missouri  63110-1093
Cancer Research and Treatment Center (University of New Mexico)Albuquerque, New Mexico  87131