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Alkylating agents

Palbociclib + Chemotherapy for Solid Tumors

Phase 1 & 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2023 Phase 2 trial • 55 Patients • NCT03007979
96%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Arthralgia
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Sinusitis
17%
Peripheral sensory neuropathy
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Urinary tract infection
13%
Hyperhidrosis
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Hypophosphatemia
9%
Epistaxis
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Skin infection
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Cellulitis
6%
Death
6%
Cataract
6%
Dehydration
6%
Knee pain
6%
Itchy skin
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Back spasms
4%
Vaginal dryness
4%
Flu-like symptoms
4%
Burn
4%
Watering eyes
4%
Edema trunk
4%
Dry eye
4%
Head injury
4%
Memory impairment
4%
Skin bump
4%
Sinus pain
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Intrascapular pain
2%
Hemorrhoids
2%
Pharyngitis
2%
Activated partial thromboplastin time prolonged
2%
Erythema right breast
2%
Sinus tachycardia
2%
Puncture wound
2%
Hypermagnesemia
2%
Vaginal discharge
2%
Leg pain
2%
Wrist fracture
2%
Erythema multiforme
2%
Cold sweats
2%
Paronychia
2%
Vaginal infection
2%
Sinus congestion
2%
Localized edema
2%
Yeast infection
2%
Diverticulitis
2%
Sepsis
2%
Photophobia
2%
Blood bilirubin increased
2%
Facial nerve disorder
2%
Paresthesia
2%
Urinary retention
2%
Hyperuricemia
2%
Agitation
2%
Oral fissure
2%
Eye lid pain
2%
Flank pain
2%
Cognitive disturbance
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
COPD
2%
Fracture
2%
Fever blister
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
2%
Lung cancer
2%
Vaginal itching
2%
Radiation recall reaction (dermatologic)
2%
Bilateral nares sores
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant

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
~3760
Temozolomide
2010
Completed Phase 3
~1930
Irinotecan
2017
Completed Phase 4
~2680
Cyclophosphamide
1995
Completed Phase 3
~3770
Topotecan
2017
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,575 Previous Clinical Trials
10,922,973 Total Patients Enrolled
1 Trials studying Rhabdoid Tumor
160 Patients Enrolled for Rhabdoid Tumor
Children's Oncology Group (COG)UNKNOWN
1 Previous Clinical Trials
229 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,482 Previous Clinical Trials
8,099,235 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03709680 — Phase 1 & 2
Rhabdoid Tumor Research Study Groups: Phase 1 Tumor specific cohort - Neuroblastoma, Phase 2 Arm A, Phase 2 Arm B, Phase 1
Rhabdoid Tumor Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03709680 — Phase 1 & 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03709680 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Who else is applying?

What site did they apply to?
Texas Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Texas Children's Hospital: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
2019. "Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03709680.
All > Hawaii > Medulloblastoma
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