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Safety and Efficacy Study of TPI-287 in Neuroblastoma and Medulloblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01483820
Recruitment Status : Terminated (Lack of enrollment)
First Posted : December 1, 2011
Results First Posted : October 28, 2016
Last Update Posted : October 28, 2016
Van Andel Research Institute
Cortice Biosciences, Inc.
Information provided by (Responsible Party):
Giselle Sholler, Spectrum Health Hospitals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Neuroblastoma
Intervention: Drug: TPI 287

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
TPI 287 Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.

Participant Flow:   Overall Study
    TPI 287
Lack of Efficacy                6 
Adverse Event                1 
Death                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
TPI 287 Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.

Baseline Measures
   TPI 287 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   8 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Participants]
Female   4 
Male   4 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   1 
Not Hispanic or Latino   7 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   8 
More than one race   0 
Unknown or Not Reported   0 

  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: length of study +30 days ]

2.  Secondary:   Number of Participants With Overall Response Assessed Using RECIST Criteria   [ Time Frame: 6 months ]

3.  Secondary:   Number of Days Participants Experienced Progression Free Survival (PFS)   [ Time Frame: 3 years ]

4.  Secondary:   Median Overall Survival (OS) of Participants   [ Time Frame: 3 years ]

5.  Secondary:   Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires   [ Time Frame: 3 years ]

6.  Secondary:   To Evaluate the Drug Levels and Pharmacokinetics (PK) of TPI 287 From Blood Samples at Multiple Time Points Within the First 24 Hours on Study.   [ Time Frame: 1 year ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Giselle Sholler, MD
Organization: NMTRC
phone: 6162670335
e-mail: giselle.sholler@helendevoschildrens.org

Responsible Party: Giselle Sholler, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT01483820     History of Changes
Other Study ID Numbers: NMTRC 004
First Submitted: November 28, 2011
First Posted: December 1, 2011
Results First Submitted: May 10, 2016
Results First Posted: October 28, 2016
Last Update Posted: October 28, 2016