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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426582
• Other study ID #: CEPO906A2105
• Status: Completed
• Phase: Phase 1
• Start date: August 2006

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• Patupilone

Locations

Country	Name	City	State
United States	Cancer Research and Treatment Center (University of New Mexico)	Albuquerque	New Mexico
United States	Wertz Clinical Cancer Center (Wayne State University)	Detroit	Michigan
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Associates in Oncology	Rockville	Maryland
United States	Siteman Cancer Center (Washington University School of Medicine)	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)		Every 3 weeks
Secondary	Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations		Every 6 weeks
Secondary	Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)		Every 6 weeks
Secondary	Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response		Every 6 weeks
Secondary	Pharmacokinetic profile of patupilone combined with carboplatin		First 6 weeks (cycle 1 & 2 only)
Secondary	Relationship between pharmacokinetics and clinical outcome		Every 6 weeks during cycle 1 & cycle 2

External Links

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