TRIAL DETAIL

Efficacy and Safety of PD-0332991 in Patients With Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (CYCLIGIST)

Drug:
Trial Name:
Efficacy and Safety of PD-0332991 in Patients With Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (CYCLIGIST)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Ongoing, but not recruiting
Phase:
2
Start Date 08/01/2013
Age of Trial (yrs) 8.3
Treatment Phase:
Gleevec-resistant
Drug Category:
Cdk4 & Cdk6 inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CYCLIGIST IB 2013-01 CSET 2090
Sponsor:
Institut Bergonié NCI France funding
Patient Contact:
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
See ClinicalTrials.gov Links (NCT#) for full site info.

This is a multicentre single-arm Phase II study evaluating the efficacy and safety of orally PD-0332991, 125 mg/day, 21 days on/7 days off, in patients with documented disease progression while on therapy with 2nd line sunitinib for unresectable and/or metastatic GIST. Indeed, the usual treatment for advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib is best supportive care for which outcome data are already available (Demetri et al., 2012; Italiano et al., 2012). Sixty three patients will be included in 10 centres of the French Sarcoma Group over a period of 18 months of enrolment.

Patients will be evaluated at scheduled visits in up to three study periods:

Pre-treatment (PRE TT): from signature of informed consent to the first treatment by PD-0332991.
Treatment (TT): from the first treatment by PD-0332991 to the first 28 days following the last PD-0332991 administration.
Follow-up (FUP): after treatment discontinuation, all patients must be followed up for 28 days after the last dose of the study drug for safety assessment (AEs and/or SAEs).

Inclusion Criteria (partial):

Male or female patients ≥ 18 years of age
Histologically confirmed GIST of any anatomical location and confirmed by the RRePS Network ; positive immunohistochemical staining for c-KIT (CD117); or negative staining for KIT, but with either positive staining for DOG1 or an identified mutation of KIT or PDGFRA gene
CDKN2A gene deletion assessed by array-comparative genomic hybridization (array-CGH)
Unresectable and/or metastatic disease with documented progression according to modified RECIST criteria (see section 7.2.1.5 of protocol) after 1st line imatinib and 2nd line sunitinib. Progression on the last line of treatment should be confirmed by central review with two radiological assessments identical (CT scans or MRI) obtained at less from 4 months interval within the 24 months before inclusion.
At least one measurable GIST lesion according to RECIST (v1.1 Appendix 3). A previously irradiated lesion is eligible to be considered as a measurable lesion provided that there is objective evidence of progression of the lesion prior to starting PD-0332991.

Patients affiliated to the French Social Security

Exclusion Criteria (partial): Patienst with prior complete gastrectomy. RB1 gene deletion assessed by array-comparative genomic hybridization (array-CGH)

Trial Links

 
 
 
 
 

Trial Results

 
 

Drug Information

Phase II trial - Efficacy and Safety of PD-0332991 in Patients With Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib (CYCLIGIST)
 
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Trial Sites

Name
Address
City
State
Zip
Country
229 Cours Argonne
Bordeaux
Gironde
33076
France
Dijon
France
Lille
59020
France
28 rue Laennec
Lyon
Rhone
69373
France
264 Rue Saint Pierre
Marseille
Bouches du Rhone
13386
France
Nantes
France
Reimes
France
Villejuif
Val de Narne
94805
France