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Palbociclib + Chemotherapy for Solid Tumors
Study Summary
This trial is testing the safety and efficacy of combining palbociclib with either irinotecan or topotecan chemotherapy in children, adolescents, and young adults with solid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 55 Patients • NCT03007979Trial Design
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Who is running the clinical trial?
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- I haven't taken strong CYP3A affecting drugs recently.My cancer has returned or didn't respond to treatment, as confirmed by a lab test.My kidney function, measured by creatinine levels, is within the normal range.My liver is working well.I have recovered from side effects of my previous cancer treatments.I am a girl over 8 years old and my pregnancy test is negative.I have brain tumors or metastases and need steroids for them.I am between 2 and 21 years old.I am mostly active and can do most of my daily activities.My bone marrow is functioning well.My neuroblastoma meets the specific criteria in the study protocol.I have not had cancer treatment within the specified timeframe.I do not have serious or unmanaged heart problems.I have a serious stomach or intestine problem.I do not have any serious or uncontrolled infections.My cancer has returned or didn't respond to treatment, and it's not EWS for certain study groups.I have previously been treated with specific drugs as listed in the study details.More than half of my bone marrow has been exposed to radiation.I have a genetic disorder that affects my bone marrow.I have not had major surgery recently.
- Group 1: Phase 1 Tumor specific cohort - Neuroblastoma
- Group 2: Phase 2 Arm A
- Group 3: Phase 2 Arm B
- Group 4: Phase 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the current research endeavor accepting applicants who are 50 or older?
"This medical trial requires that patients be aged between two and twenty years old. Clinicaltrials.gov currently lists 969 trials for minors, while 3906 studies are recruiting senior citizens."
Is it possible for me to register as a participant in this research endeavor?
"This trial is recruiting 184 minors aged 2-20 with neuroblastoma. Additional inclusion criteria include: histologically confirmed relapsed or refractory solid tumors (including CNS but not lymphomas); for EWS-specific cohorts, histopathology confirmation of both EWSR1-ETS and FUS-ETS rearrangements; a Lansky performance status ≥50% for patients ≤16 years old, ECOG 0/1/2 for those >16; absolute neutrophil count ≥1000mm3, platelet count ≥100000 mm3 without transfusions in the past week; hemoglobin at 8.5 g/dL"
To what extent is this research endeavor accommodating participants?
"To complete the trial, Pfizer requires 184 participants that meet all of the study's criteria. The pharmaceutical company will host enrolment at Robert Wood Johnson University Hospital in New Brunswick and Hackensack University Medical Center in Hackensack."
How many establishments have adopted this trial protocol?
"As of now, this clinical trial is seeking 76 participants and can be found in several locations such as Robert Wood Johnson University Hospital in New Brunswick, Hackensack University Medical Center in Hackensack and Rutgers Cancer Institute of New jersey. Additionally, there are many other venues where the study is actively recruiting patients."
Is enrollment for this trial still open?
"As per the information available on clinicaltrials.gov, recruitment for this medical investigation is ongoing and began on May 24th 2019 with a refresh of data posted in September 25th 2022."
Has Palbociclib been subject to any other investigations?
"At the current time, Palbociclib is the subject of 1398 clinical trials worldwide. Of these studies, 255 are at Phase 3 with Philadelphia, Pennsylvania playing host to the bulk of them. Globally 47991 medical centres have begun research into this drug's efficacy and safety."
Has Palbociclib been confirmed by the FDA?
"Due to its Phase 2 status, the safety of Palbociclib was rated a 2 on our 3-level scale as there is some data indicating it is safe but no information that demonstrates efficacy."
What medical conditions can be treated by Palbociclib?
"Palbociclib is a powerful pharmaceutical that can assist in the treatment of small cell lung cancer (SCLC) as well as progression disease, multiple sclerosis, and acute myelocytic leukemia."
What key findings are researchers hoping to glean from this research?
"The primary end-result of this trial, which will be evaluated within a period spanning at least 28 days after the last dosage, is to measure phase 1 dose limiting toxicities. Secondary objectives include observing irinotecan and its active metabolites' pharmacokinetics; referring to maximum observed plasma concentration during steady state dosing intervals (Css, max) in both Phase 1 and 2 trials as data permits; and determining overall survival rate from enrollment date till death due to other causes (OS). Additionally, measurement of area under the concentration-time curve during steady state dosing intervals (AUCss,t) for multiple doses can"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Texas Children's Hospital: < 48 hours
Typically responds via
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