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PI3K Inhibitor

Copanlisib + Ketogenic Diet for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Jennifer E. Amengual, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For EC the patients must have recurrent/advanced tumor for which surgical or the systemic curative treatments, or standard therapeutic approaches are not available. The following histologic subtypes are eligible: endometrioid, serous, clear cell, undifferentiated /dedifferentiated, mucinous, squamous, transitional, not-otherwise specified, and mixed celltype

Fresh and or archived tumor tissues must be available to (a) establish the diagnosis of the respective malignancies as described in Inclusion Criteria, and (b) be investigated for biomarkers. Patients without historical material or fresh tissue biopsy that is adequate for both diagnosis and correlative studies will not be eligible for the clinical trial

Must not have

Patients that have not recovered from adverse events due to chemotherapy agents administered more than 3 weeks earlier

Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix 5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 58 weeks or 4 weeks after the last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug in combination with a ketogenic diet in patients with either relapsed or refractory follicular lymphoma or endometrial cancer.

Who is the study for?

Adults with relapsed or refractory follicular lymphoma or endometrial cancer, who have tried at least two prior therapies for FL and have no standard treatment options for EC. Participants must be over 18, able to consent, have a heart function above 50%, an ECOG score of 0-2 indicating they are relatively active, stable organ function, and not pregnant. They should also agree to use effective contraception.

What is being tested?

The trial is testing the combination of a PI3K inhibitor drug called Copanlisib with a ketogenic diet in patients with specific types of cancer that either came back after treatment or didn't respond to previous treatments. The study will include people whose cancers have certain genetic changes.

What are the potential side effects?

Potential side effects may include high blood sugar levels (especially important for those with diabetes), infections due to weakened immune systems, allergic reactions to Copanlisib's ingredients, and possibly increased risk of heart-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My endometrial cancer cannot be treated with surgery or standard therapies.

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I have available tumor tissue samples for diagnosis and biomarker testing.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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I still have side effects from chemotherapy I received over 3 weeks ago.

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I have heart pain or symptoms related to heart disease.

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I am still recovering from major surgery complications.

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I am not taking strong CYP3A4 inhibitor medications.

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I have not had a heart attack in the last 6 months.

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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.

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I do not have a serious infection worse than a moderate level.

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My diabetes is not well-controlled (HbA1c > 7.5%).

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I am being treated for Type II diabetes with specific medications or insulin.

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I have heart failure classified as moderate to severe, or my heart's pumping ability is significantly reduced.

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I have a history of severe or uncontrolled gout or high uric acid levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 58 weeks or 4 weeks after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 58 weeks or 4 weeks after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 58 weeks or 4 weeks after the last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Complete Response (CR) Rate

ORR at the Simon stage I analysis

Partial Response (PR) Rate

+1 more

Side effects data

From 2021 Phase 2 trial • 24 Patients • NCT02631590

75%

Platelet count decreased

75%

Lymphocyte count decreased

71%

Fatigue

71%

White blood cell decreased

67%

Anemia

67%

Neutrophil count decreased

63%

Hypertension

54%

Hyperglycemia

50%

Nausea

46%

Diarrhea

46%

Lipase increased

46%

Anorexia

42%

Alanine aminotransferase increased

42%

Abdominal Pain

33%

Fever

29%

Hyponatremia

25%

Weight loss

25%

Dehydration

25%

Hyperkalemia

25%

Hypotension

25%

Vomiting

25%

Constipation

25%

Rash maculo-papular

21%

Edema limbs

21%

Aspartate aminotransferase increased

21%

Serum amylase increased

17%

Chills

17%

Pain

17%

Alkaline phosphatase increased

17%

Creatinine increased

17%

Thromboembolic event

17%

Sinus tachycardia

17%

Dizziness

13%

Pain in extremity

13%

Generalized muscle weakness

13%

Dyspnea

13%

Blood bilirubin increased

13%

Hypoalbuminemia

13%

Infusion related reaction

13%

Non-cardiac chest pain

13%

Gastrointestinal disorders - Other

13%

Mucositis oral

13%

Sepsis

13%

Upper respiratory infection

13%

Urinary tract infection

13%

Anxiety

13%

Tinnitus

Back pain

Pleural effusion

Cough

Hypoxia

Ascites

Neck pain

Insomnia

Gallbladder obstruction

Bloating

General disorders and administration site conditions -Other

Abdominal distension

Dysphagia

Pruritus

Rash acneiform

Peripheral sensory neuropathy

Infections and infestations - Other

Dysgeusia

Depression

Neoplasms benign, malignant and unspecified - Other

Phlebitis

Colitis

Colonic obstruction

Gastrointestinal disorders -Other

Cholecystitis

Dry mouth

Pancreatitis

Stomach pain

Toothache

Gait disturbance

Infusion site extravasation

Activated partial thromboplastin time prolonged

Blood antidiuretic hormone abnormal

Investigations - Other

Urine output decreased

Hypercalcemia

Hypernatremia

Hyperuricemia

Hypokalemia

Hypomagnesemia

Aspiration

Atelectasis

Epistaxis

Hiccups

Hoarseness

Nasal congestion

Pneumonitis

Postnasal drip

Productive cough

Sore throat

Wheezing

Bone pain

Paroxysmal atrial tachycardia

Pericarditis

Confusion

Acute kidney injury

Ear pain

Cataract

Dry eye

Fracture

Injury, poisoning and procedural complications - Other

Venous injury

Allergic reaction

Hepatic infection

Infections and Infestations - Other

Urinary tract obstruction

Lung infection

Gastroesophageal reflux disease

Malaise

Musculoskeletal and connective tissue disorders - Other

Skin ulceration

Headache

Parathesia

Gallbladder infection

Dry skin

Skin and subcutaneous tissue disorders - Other

Sinus bradycardia

Cystitis noninfective

Hematuria

Renal and urinary disorders - Other

Urine discoloration

100%

80%

60%

40%

20%

Study treatment Arm

Combination Therapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Follicular Lymphoma (FL)Experimental Treatment2 Interventions

The lymphoma study group will enroll 23 patients with FL. In cycle 1, patients will first start ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.

Group II: Endometrial Cancer (EC)Experimental Treatment2 Interventions

The solid tumor group will enroll 19 patients with EC. In cycle 1, patients will first start ketogenic diet for 7 days (Day -6 to Day 0). Only patients who demonstrate compliance and tolerance with the ketogenic diet for all 7 days, as confirmed by pertinent blood and urine tests, will be allowed to continue the study and treatment using copanlisib and the ketogenic diet starting on Day 1. In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copanlisib

2016

Completed Phase 2

~130

0 / 15Eligibility criteria met