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

NCT ID: NCT00426582

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Advanced Solid Tumors

Keywords

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Cancer maximum tolerated dose dose-limiting toxicity patupilone carboplatin pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patupilone only

Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin

Group Type EXPERIMENTAL

Patupilone

Intervention Type DRUG

Carboplatin alone

Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin

Group Type ACTIVE_COMPARATOR

Patupilone

Intervention Type DRUG

Interventions

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Patupilone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Associates in Oncology

Rockville, Maryland, United States

Site Status

Wertz Clinical Cancer Center (Wayne State University)

Detroit, Michigan, United States

Site Status

Siteman Cancer Center (Washington University School of Medicine)

St Louis, Missouri, United States

Site Status

Cancer Research and Treatment Center (University of New Mexico)

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=5244

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

Other Identifiers

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CEPO906A2105

Identifier Type: -

Identifier Source: org_study_id