Phase 1/2 study to evaluate Palbociclib (IbranceÃ?Â®) in combination with Irinotecan and Temozolomide and/or in combination with Topotecan and Cyclophosphamide in pediatric patients with recurrent or refractory solid tumors

Pfizer Inc0 sites0 target enrollmentTBD

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Pfizer Inc
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Investigators

Sponsor

Pfizer Inc

Eligibility Criteria

Inclusion Criteria

•(1\) Histologically confirmed relapsed or refractory solid tumor: For randomized Phase 2 part: Histologically confirmed Ewing sarcoma. Histopathology confirmation of EWSR1\-ETS or FUS\-ETS rearrangement is required or availability of formalin fixed paraffin embedded (FFPE) tumor tissue sample for central testing. Patient must have relapsed or refractory disease with no known bone marrow metastases and at least evaluable disease.
•(2\) Age above 2 and lower than 21 years at the time of study entry.
•(3\) Lansky performance status more than 50% for patients less than 16 years of age, or Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 for patients above 16 years of age.
•(4\) Adequate bone marrow function.
•(5\) Adequate renal function: Serum creatinine level based on age/gender must within protocol specified limits.
•(6\) Adequate liver function, including:
•(7\) Patients enrolled to Phase 1 portion of the study and tumor specific cohorts must have measurable disease as defined by RECIST version 1\.1 or modified RANO criteria for CNS disease or INRC for neuroblastoma. Patients with EWS enrolled to Phase 2 portion of the study are eligible with evaluable disease (eg, bone only disease with no soft tissue component).
•(8\) Recovered to CTCAE Grade less than 1, or to baseline, from any non\-hematological acute toxicities of prior surgery, chemotherapy, immunotherapy, radiotherapy, differentiation therapy or biologic therapy, with the exception of alopecia.
•(9\) Serum/urine pregnancy test (for all girls above 8 years of age) negative at screening and at the baseline visit.
•(10\) Evidence of a personally signed and dated informed consent document indicating that the patient or a legally acceptable representative/parent(s)/legal guardian of minors, has been informed of all pertinent aspects of the study. Minor study patients also must provide age appropriate assent according to the local guidelines, where applicable.

Exclusion Criteria

•1\. Prior intolerability to IRN and/or TMZ plus/minus palbociclib with IRN and TMZ combination and prior intolerability to TOPO and/or CTX for TOPO and CTX combination.
•2\. Use of strong cytochrome P450 (CYP) 3A inhibitors or inducers. Patients who are receiving strong uridine diphosphate\-glucuronosyl transferase 1A1 (UGT1A1\) inhibitors within 12 days of Cycle 1 Day 1 (C1D1\) are not eligible for the palbociclib with IRN and TMZ combination. Patients who are receiving strong UGT1A1 inhibitors within 12 days of C1D1 are eligible for the palbociclib with TOPO and CTX combination (See Section 5\.7\.1 for list of products.)
•3\. Prior growth factors (including filgrastim) within 7 days before study entry or PEG\-filgrastim within 14 days before study entry.
•4\. Radiation therapy within 14 days before study entry.
•5\. Systemic anti cancer therapy within 2 weeks prior to study entry and 6 weeks for nitrosoureas.
•6\. Previous high dose chemotherapy requiring stem cell rescue within 90 days or persistent AE \>Grade 1\.
•7\. Prior irradiation to \>50% of the bone marrow (see Appendix 9\).
•8\. Participation in other studies involving investigational drug(s) within 2 weeks or 5 half lives, whichever is longer, prior to study entry.
•9\. Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries.
•10\. For IRN and TMZ with/without palbociclib combinations: known or suspected hypersensitivity to palbociclib, IRN and/or TMZ. For combination of palbociclib with TOPO and CTX: known or suspected hypersensitivity to palbociclib, TOPO and/or CTX.

Outcomes

Primary Outcomes

Not specified

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