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Alkylating agents

Palbociclib + Chemotherapy for Solid Tumors

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed relapsed or refractory solid tumor as specified in the protocol
Adequate renal function as defined by serum creatinine level within protocol specified limits
Must not have
Patients with known symptomatic brain tumors or brain metastases requiring steroids under specified conditions
History of clinically significant or uncontrolled cardiac disease as specified
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for children and young adults aged 2-21 with relapsed or refractory solid tumors, including specific types like Ewing sarcoma. They must have a certain level of physical ability, adequate organ function, measurable disease, and not be pregnant. Those with severe allergies to the drugs used or serious health issues are excluded.
What is being tested?
The study tests Palbociclib combined with chemotherapy (Temozolomide/Irinotecan or Topotecan/Cyclophosphamide) to find the safest high dose in phase 1 and its effectiveness compared to just chemo in phase 2 for Ewing sarcoma.
What are the potential side effects?
Possible side effects include low blood cell counts leading to infection risk, fatigue, nausea, liver issues, diarrhea. There's also a chance of allergic reactions to the medications used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or didn't respond to treatment, as confirmed by a lab test.
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My kidney function, measured by creatinine levels, is within the normal range.
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My liver is working well.
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I am a girl over 8 years old and my pregnancy test is negative.
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I am between 2 and 21 years old.
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I am mostly active and can do most of my daily activities.
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My bone marrow is functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain tumors or metastases and need steroids for them.
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I do not have serious or unmanaged heart problems.
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I have a serious stomach or intestine problem.
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I do not have any serious or uncontrolled infections.
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More than half of my bone marrow has been exposed to radiation.
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I have a genetic disorder that affects my bone marrow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Dose Expansion Parts: Frequency of adverse events
Phase 1: Dose Expansion Parts: Percentage of Participants With Complete Response or Partial Response
Phase 1: First Cycle Dose-Limiting Toxicities (DLT)
+1 more
Secondary study objectives
Phase 1 and Phase 2: Duration of response (DoR) for Participants Who Achieved Complete Response or Partial Response
Phase 1 and Phase 2: Frequency of adverse events
Phase 1 and Phase 2: Irinotecan (and active metabolites) Pharmacokinetics, Area under the concentration-time curve during a dosing interval at steady state (AUCss,t)
+33 more

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
73%
Palmar-plantar erythrodysesthesia syndrome
58%
Fatigue
56%
Diarrhea
38%
Hypertension
38%
Nausea
30%
Mucositis
29%
Vomiting
26%
Weight loss
26%
Weight gain
24%
Anorexia
20%
Nail disorder
17%
Back pain
16%
Hypothermia
15%
Constipation
15%
Abdominal pain
14%
Neutrophil count decreased
13%
Upper respiratory infection
13%
Headache
13%
Dizziness
11%
Dyspepsia
10%
Pain in extremity
10%
Fever
10%
Obesity
10%
Dysgeusia
9%
Arthralgia
9%
Bone pain
9%
Anemia
8%
Cough
8%
Pruritus
7%
Flu like symptoms
6%
Pain
4%
Alopecia
2%
Thromboembolic event
2%
Bone fracture
1%
Febrile neutropenia
1%
Respiratory infection
1%
Pancreatitis
1%
Hot flashes
1%
Spinal cord compression
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane
Cohort 2: Palbociclib Plus Fulvestrant

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 Arm AExperimental Treatment3 Interventions
Palbociclib in combination with irinotecan and temozolomide.
Group II: Phase 1 Tumor specific cohort - NeuroblastomaExperimental Treatment3 Interventions
Palbociclib in combination with topotecan and cyclophosphamide.
Group III: Phase 1Experimental Treatment5 Interventions
Palbociclib in combination with temozolomide and irinotecan and/or with topotecan and cyclophosphamide.
Group IV: Phase 2 Arm BActive Control2 Interventions
Irinotecan and temozolomide alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3880
Temozolomide
2010
Completed Phase 3
~1880
Irinotecan
2017
Completed Phase 3
~2590
Cyclophosphamide
2010
Completed Phase 4
~2310
Topotecan
2017
Completed Phase 3
~2460

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,649 Previous Clinical Trials
17,744,248 Total Patients Enrolled
1 Trials studying Diffuse Intrinsic Pontine Glioma
15 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Children's Oncology Group (COG)UNKNOWN
1 Previous Clinical Trials
229 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,536 Previous Clinical Trials
14,915,436 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03709680 — Phase 2
Diffuse Intrinsic Pontine Glioma Research Study Groups: Phase 1 Tumor specific cohort - Neuroblastoma, Phase 2 Arm A, Phase 2 Arm B, Phase 1
Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03709680 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03709680 — Phase 2
~20 spots leftby Nov 2025
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