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PI3K/mTOR Inhibitor
Palbociclib + Gedatolisib for Solid Cancers
Phase 1
Recruiting
Led By Geoffrey Shapiro, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically confirmed malignancy that is metastatic or unresectable and resistant to standard therapy or for which no standard therapy is available
ECOG performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if they can treat cancer that has a specific change in the PI3K pathway.
Who is the study for?
Adults with advanced squamous cell lung, pancreatic, head & neck cancers or solid tumors potentially linked to PI3K-pathway changes. They must have acceptable organ function and blood counts, no severe diabetes or heart conditions, not be on certain drugs affecting liver enzymes or the heart's rhythm, and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing a drug combo of Palbociclib and Gedatolisib for treating advanced cancers. It aims to see if these drugs can help patients whose cancer might be affected by specific genetic changes in the PI3K pathway.See study design
What are the potential side effects?
Possible side effects include issues from lowered blood counts like increased infection risk, fatigue; abnormal liver tests; potential heart problems (QT prolongation); high blood sugar levels; and digestive disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread, can't be surgically removed, and doesn't respond to standard treatments.
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I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
My cancer is advanced and either affects the lung, pancreas, head & neck, or is linked to the PI3K-pathway.
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My organ and bone marrow functions are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Maximum Tolerated Dose and Recommended Phase 2 Dose
Secondary outcome measures
Overall Response Rate
Pharmacokinetic parameter (area under the curve [AUC]) of gedatolisib in the absence or presence of palbociclib
Pharmacokinetic parameter (half-life [t1/2]) of gedatolisib in the absence or presence of palbociclib
+6 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
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%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Upper respiratory infection
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Blurred vision
7%
Tooth infection
7%
Non-cardiac chest pain
7%
Skin infection
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Death
6%
Cellulitis
6%
Cataract
6%
Itchy skin
6%
Dehydration
6%
Knee pain
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%
Vaginal dryness
4%
Watering eyes
4%
Burn
4%
Flu-like symptoms
4%
Edema trunk
4%
Back spasms
4%
Dry eye
4%
Sinus pain
4%
Head injury
4%
Memory impairment
4%
Skin bump
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%
Bilateral nares sores
2%
Puncture wound
2%
Cold sweats
2%
Localized edema
2%
Wrist fracture
2%
Activated partial thromboplastin time prolonged
2%
Lung cancer
2%
Vaginal discharge
2%
Erythema multiforme
2%
Erythema right breast
2%
Paronychia
2%
Vaginal infection
2%
COPD
2%
Sinus congestion
2%
Sinus tachycardia
2%
Diverticulitis
2%
Sepsis
2%
Hyperuricemia
2%
Facial nerve disorder
2%
Paresthesia
2%
Agitation
2%
Urinary retention
2%
Oral fissure
2%
Eye lid pain
2%
Pharyngitis
2%
Blood bilirubin increased
2%
Flank pain
2%
Cognitive disturbance
2%
Radiation recall reaction (dermatologic)
2%
Photophobia
2%
Generalized weakness
2%
Rhinovirus
2%
Wound infection
2%
Fracture
2%
Vaginal itching
2%
Fever blister
2%
Hemorrhoids
2%
Yeast infection
2%
Intrascapular pain
2%
Wrist pain
2%
Hoarseness
2%
Laryngeal inflammation
2%
Leg pain
2%
Bladder infection
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Hypermagnesemia
2%
Urine discoloration
2%
Nail loss
2%
Shoulder nodule
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
1Treatment groups
Experimental Treatment
Group I: Combination Of Palbociclib and GedatolisibExperimental Treatment2 Interventions
Palbociclib will be administered orally once daily on Days 1-21 for each of the 4-week cycles at a pre-determined dose.
Gedatolisib will be administered intravenously once weekly on the first day for each of the four weeks during the 4-week cycles at a pre-determined dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gedatolisib
2018
Completed Phase 1
~160
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,778 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,852 Total Patients Enrolled
Geoffrey Shapiro, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Brigham & Women'S Hospital (Residency)
3 Previous Clinical Trials
141 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread, can't be surgically removed, and doesn't respond to standard treatments.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I have had chemotherapy or radiotherapy recently.I am currently using or might need specific medications or special foods.I do not have brain metastases needing treatment.I have cancer that can be evaluated but not measured for Part I, or cancer that can be measured for Part II.My cancer is advanced and either affects the lung, pancreas, head & neck, or is linked to the PI3K-pathway.I agree to use birth control during the study.My organ and bone marrow functions are normal.I do not have any unmanaged ongoing illnesses.I have a history of diabetes.I am not using, nor do I plan to use, certain medications.I am not taking proton pump inhibitors with palbociclib.I have a history of heart conditions or abnormal heart rhythm.I am currently taking medication that can affect my heart's rhythm.I have had previous treatments for my condition.I do not have any serious infections right now.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Of Palbociclib and Gedatolisib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are contributing to this scientific endeavor?
"Affirmative, the clinicaltrials.gov website alludes to this medical study's current recruitment status. Initially posted on February 28th 2017, it has since undergone a recent update on January 18th 2022 with plans of enrolling 96 patients at 3 distinct sites."
Answered by AI
In what circumstances is Palbociclib typically prescribed?
"Palbociclib is often employed to treat breast cancer, but can also be useful when managing malignant neoplasms, advanced directives and postmenopausal issues."
Answered by AI
Are there any available slots for prospective participants in this research project?
"This particular clinical trial is presently enrolling patients; its initial posting was on February 28th 2017 and the latest amendment was made January 18th 2022."
Answered by AI
Has the FDA sanctioned Palbociclib for medical use?
"The safety of Palbociclib is assessed to be a 1, since this Phase 1 trial has only little evidence backing its effectiveness and security."
Answered by AI
Is Palbociclib an experimental medicine for which prior research has taken place?
"As of the present moment, there are 134 active clinical trials for Palbociclib with 16 in Phase 3. These studies primarily occur in Burgas, New jersey; yet there is a total 6582 sites where research on this drug is being conducted."
Answered by AI
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