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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

Must not have

Participants with symptomatic brain metastases that require active treatment are excluded

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

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I am 18 years old or older.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain metastases needing treatment.

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I do not have any unmanaged ongoing illnesses.

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I have a history of diabetes.

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I am not using, nor do I plan to use, certain medications.

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I am not taking proton pump inhibitors with palbociclib.

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I have a history of heart conditions or abnormal heart rhythm.

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I am currently taking medication that can affect my heart's rhythm.

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I do not have any serious infections right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Incidence of Treatment-Emergent Adverse Events

Maximum Tolerated Dose and Recommended Phase 2 Dose

Secondary study objectives

Overall Response Rate

Progression Free Survival Rate at 4 months

Target engagement of palbociclib and gedatolisib in paired tumor biopsies

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507

63%

Neutrophil count decreased

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Diarrhea

17%

Headache

17%

Mucositis

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Flu like symptoms

10%

Obesity

Pain in extremity

Constipation

Fever

Pruritus

Bone pain

Dizziness

Dyspepsia

Hot flashes

Dysgeusia

Pain

Nail disorder

Respiratory infection

Abdominal pain

Spinal cord compression

Heart failure

Bronchial infection

Pleural effusion

Ascites

Urinary tract infection

Breast infection

Dyspnea

Gallbladder infection

Renal failure

Thromboembolic event

Dislocation of hip

Palmar-plantar erythrodysesthesia syndrome

Osteonecrosis of jaw

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3880