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

NCT01396148 | Completed Phase 2 Results

• 2 other identifiers: A61811962011-002008-33
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 9

Brief Summary

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Children and young adults with GIST; sunitinib malate; pharmacokinetics; tumor response; overall survival; tumor KIT mutation status

Outcome Measures

Primary Outcomes (6)

• Estimated Steady-State Maximum Plasma Concentration (Cmax,ss) of Sunitinib and Its Metabolite

  Estimated steady-state maximum plasma concentration (Cmax,ss) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.

  pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1

• Estimated Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose AUC(0-24) of Sunitinib and Its Metabolite

  Estimated area under the plasma concentration versus time curve from time zero to 24 hours post dose (AUC24) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.

  pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1

• Estimated Oral Clearance (CL/F) of Sunitinib and Its Metabolite

  SU012662 is the metabolite of Sunitinib. Oral clearance (CL/F) is a quantitative measure of the rate at which a drug substance is removed from the blood (CL) normalized by the oral bioavailability of the drug (F). Summarized data for all time points was reported.

  pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1

• Maximum Observed Plasma Concentration (Cmax) of Sunitinib and Its Metabolite

  SU012662 is the metabolite of Sunitinib.

  Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for Sunitinib and Its Metabolite

  SU012662 is the metabolite of Sunitinib.

  Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose

• Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose AUC(0-8) for Sunitinib and Its Metabolite

  AUC(0-8) was defined as area under the plasma concentration time-curve from time zero to 8 hours post dose. SU012662 is the metabolite of Sunitinib.

  Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose

Secondary Outcomes (16)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0

  Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)

• Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)

• Number of Participants With Objective Response

  Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)

Study Arms (2)

Children with GIST

EXPERIMENTAL

children ages 6yrs-\<18yrs

Drug: sunitinib malate dose escalation

Young adults with GIST

EXPERIMENTAL

young adults ages 18yrs-\<21 yrs

Drug: sunitinib malate

Interventions

sunitinib malate dose escalation DRUG

sunitinib starting dose will be 15mg/m\^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).

Children with GIST

sunitinib malate DRUG

sunitinib 50mg daily on Schedule 4/2

Young adults with GIST

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Current treatment with another investigational agent.
• Prior sunitinib treatment.
• Prior therapy with known risk for cardiovascular complications.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Fakultni nemocnice Brno

Brno, 613 00, Czechia

Location

FN Brno

Brno, 625 00, Czechia

Location

Masarykuv onkologicky ustav

Brno, 656 33, Czechia

Location

CHU de La Timone, Hopital enfants

Marseille, 13385, France

Location

Hopital d'Enfants de la Timone

Marseille, 13385, France

Location

Hopital de la Timone

Marseille, 13385, France

Location

Related Publications (2)

• Wang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14.

  PMID: 33852135 DERIVED

• Verschuur AC, Bajciova V, Mascarenhas L, Khosravan R, Lin X, Ingrosso A, Janeway KA. Sunitinib in pediatric patients with advanced gastrointestinal stromal tumor: results from a phase I/II trial. Cancer Chemother Pharmacol. 2019 Jul;84(1):41-50. doi: 10.1007/s00280-019-03814-5. Epub 2019 Apr 20.

  PMID: 31006038 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 18, 2011
• Study Start: June 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 27, 2019
• Results First Posted: March 12, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3); FR (3); CZ (3)