NCT00426582

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

December 9, 2020

Status Verified

March 1, 2011

Enrollment Period

4 years

First QC Date

January 24, 2007

Last Update Submit

December 6, 2020

Conditions

Advanced Solid Tumors

Keywords

Cancermaximum tolerated dosedose-limiting toxicitypatupilonecarboplatinpharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

    Every 3 weeks

Secondary Outcomes (5)

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

    Every 6 weeks

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

    Every 6 weeks

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

    Every 6 weeks

  • Pharmacokinetic profile of patupilone combined with carboplatin

    First 6 weeks (cycle 1 & 2 only)

  • Relationship between pharmacokinetics and clinical outcome

    Every 6 weeks during cycle 1 & cycle 2

Study Arms (2)

Patupilone only

EXPERIMENTAL

Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin

Drug: Patupilone

Carboplatin alone

ACTIVE COMPARATOR

Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin

Drug: Patupilone

Interventions

PatupiloneDRUG
Carboplatin alonePatupilone only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Associates in Oncology

Rockville, Maryland, 20850, United States

Location

Wertz Clinical Cancer Center (Wayne State University)

Detroit, Michigan, 48201, United States

Location

Siteman Cancer Center (Washington University School of Medicine)

St Louis, Missouri, 63110-1093, United States

Location

Cancer Research and Treatment Center (University of New Mexico)

Albuquerque, New Mexico, 87131, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

epothilone B

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 25, 2007

Study Start

August 1, 2006

Primary Completion

August 1, 2010

Last Updated

December 9, 2020

Record last verified: 2011-03

Locations

US(5)