ADVL1921, PHASE 1 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

About this Study

This study is for children and adolescents with recurrent and refractory tumors.  We will add an experimental drug, Palbociclib, to standard chemotherapy in the hopes it will shrink or get rid of the tumor for a time. 

Sponsor Protocol ID:A5481092
IRB Number:2019-0115
Actively Enrolling
Interventional
Phase 1
November 14, 2019
Eligibility Criteria
2 years old
21 years old
Both Male and Female
Yes
No
No

Inclusion CriteriaAge ≥2 and

Serum/urine pregnancy test (for all girls ≥8 years of age) negative at screening and at the baseline visit. 

Evidence of a personally signed and dated informed consent document indicating that the patient or a legally acceptable representative/parent(s)/legal guardian, for 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.

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures. 

Exclusion CriteriaPrior growth factors within 7 days before study entry or peg-filgrastim within 14 days before study entry

Radiation therapy within 14 days before study entry. 

Major surgery within 4 weeks prior to study entry. Surgical biopsies or central line placement are not considered major surgeries. 

Patients with known symptomatic brain tumors or brain metastases and require steroids, unless they have been on a stable or on a decreasing steroid dose for >14 days.

Patients with previously diagnosed brain metastases are eligible if they have completed their prior treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry for these metastases for at least 14 days post-radiation and 4 weeks post-surgery and are neurologically stable. 

Evidence of serious active or uncontrolled bacterial, fungal or viral infection or known history of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness. 

Other severe acute or chronic medical or laboratory test abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the Investigator, would make the patient inappropriate for entry into this study. 

Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 90 after the last dose of investigational product. 


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Cancer
Pediatrics
Participating Locations
Batson Children’s Hospital
Contact Information
Contact Name: Rachel Lowery
Phone Number: 601-984-5224
Email: rlowery@umc.edu
Principal Investigator:Collier, Anderson B, M.D.
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