A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01396148
First received: July 13, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
Drug: sunitinib malate dose escalation
Drug: sunitinib malate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/ii Study Of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics- Estimated steady-state maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- estimated area under the plasma concentration versus time curve from time zero to 24 hours post dose (AUC24) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- estimated oral clearance (CL/F) for sunitinib [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- Observed single-dose maximum plasma concentration (Cmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- Observed time to Cmax (tmax) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics- Observed area under the plasma concentration versus time curve from time zero to 8 hours post dose (AUC8) for sunitinib and its active metabolite SU012662 [ Time Frame: Weeks 1-18 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Overall survival at 2 years after study enrollment [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected efficacy parameter (eg, sum of largest diameters for target tumors) is observed [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: No ]
  • Estimated sunitinib plasma concentration at which 50% of the maximum effect for each selected safety endpoint (eg, absolute neutrophil count) is observed [ Time Frame: up to 2 years after study enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Children with GIST
children ages 6yrs-<18yrs
Drug: sunitinib malate dose escalation
sunitinib starting dose will be 15mg/m^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).
Experimental: Young adults with GIST
young adults ages 18yrs-<21 yrs
Drug: sunitinib malate
sunitinib 50mg daily on Schedule 4/2

  Eligibility

Ages Eligible for Study:   6 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of GIST.
  • Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
  • Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease.

Exclusion Criteria:

  • Current treatment with another investigational agent.
  • Prior sunitinib treatment.
  • Prior therapy with known risk for cardiovascular complications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396148

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 34 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396148     History of Changes
Other Study ID Numbers: A6181196, 2011-002008-33
Study First Received: July 13, 2011
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Children and young adults with GIST
sunitinib malate
pharmacokinetics
tumor response
overall survival
tumor KIT mutation status

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014