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PI3K inhibitor

Triple Drug Combo for Advanced Cancer

Phase 1
Waitlist Available
Led By Timothy A Yap
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
GFR >= 51 mL/min, based on a 24-hour urine test for creatinine clearance or estimated using the Cockcroft-Gault equation
LVEF >= 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of copanlisib and olaparib when given together with durvalumab, and how well they work in treating patients with metastatic or unresectable solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have spread or can't be removed by surgery, and who haven't responded to standard treatments. Participants must have specific gene mutations (like BRCA1/2 or PTEN), meet certain blood and organ function criteria, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have had certain recent treatments or uncontrolled illnesses.Check my eligibility
What is being tested?
The trial tests a combination of three anti-cancer drugs: Copanlisib (blocks enzymes for cell growth), Olaparib (stops tumor cells from repairing DNA damage), and Durvalumab (helps the immune system attack cancer). It aims to find the best dose with acceptable side effects and see if this combo works better than current treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system attacking normal organs, infusion-related reactions from drug administration, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk or bleeding problems. Specific risks will vary based on individual patient health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by GFR, is 51 mL/min or higher.
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My heart's pumping ability is normal or above.
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I am mostly self-sufficient and can carry out daily activities.
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I am 18 years old or older.
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My hemoglobin level is at least 10 g/dL without recent blood transfusions.
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My cancer has spread, cannot be surgically removed, and standard treatments are not effective.
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My cancer is advanced, cannot be surgically removed, and standard treatments are not effective.
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I am 18 years old or older.
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It's been over 3 weeks since my last chemotherapy or 4 weeks since any experimental treatment.
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My tumor can be easily biopsied.
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My cancer has specific mutations and will be reviewed for the best treatment group.
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My cancer has specific genetic changes in DDR, PTEN, or PIK3CA genes.
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My hemoglobin level is at least 10 g/dL and I haven't had a blood transfusion in the last 28 days.
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My cancer has specific genetic changes recognized by experts.
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I am mostly active and can carry out light work.

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
Maximum-tolerated dose (MTD) of copanlisib and olaparib
Secondary outcome measures
Copy number variation profile
Duration of response
Immune-modulatory changes
+8 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (copanlisib hydrochloride, olaparib, and durvalumab)Experimental Treatment9 Interventions
Patients receive copanlisib hydrochloride IV over 1 hour on days 1 and 15 or days 1, 8, and 15 depending on dose level and olaparib PO BID on days 1-28 of each cycle. Beginning cycle 2, patients receive durvalumab IV over 1 hour on day 1 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples at baseline within 7 days of C1D1, days 8 and 15 of cycle 1 and day 15 of subsequent cycles, at time of restaging, and end of treatment/progression. Patients undergo x-ray, CT, and MRI at the end of cycle 2 and then every 8 weeks. Patients also undergo an ECHO during pre-study within 28 days of C1D1 and tumor biopsy at baseline within 7 days of C1D1 and day 15 of cycle 1 or 2, and may undergo an optional biopsy at end of treatment/progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Olaparib
2007
Completed Phase 4
~2140
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Durvalumab
2017
Completed Phase 2
~3870
Echocardiography
2013
Completed Phase 4
~11670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,538 Total Patients Enrolled
Timothy A YapPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
9 Previous Clinical Trials
428 Total Patients Enrolled

Frequently Asked Questions

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

Has Durvalumab gained authorization from the Food and Drug Administration?

"Durvalumab's safety has been documented, but only in a limited capacity. Consequently, the risk level of this drug is assessed as 1 on our team's scale."

Answered by AI

How widely available is this investigation being conducted?

"This experiment is open for enrollment in 6 different locations, including the University of Texas at Austin and Dana-Farber Cancer Institute. Furthermore, there are 4 other medical sites involved in this trial."

Answered by AI

What is the general purpose of Durvalumab treatment?

"Durvalumab is commonly used as a supplementary treatment for chemotherapy and has been successful in treating primary peritoneal cancer, therapeutic procedures, and pharmacotherapies."

Answered by AI

How many participants have been included in this experiment?

"Affirmative, the information on clinicaltrials.gov provides evidence that this trial is still seeking applicants. It was initially posted in August 2019 and amended most recently in November 2022, with a need for 108 volunteers from 6 sites."

Answered by AI

Could you please provide a synopsis of the previous investigations into Durvalumab's efficacy?

"Durvalumab was first studied in 2005 at Research Site and has since seen 313 trials to completion. Presently, there are 513 active clinical studies involving durvalumab across the globe; of which many are located in Austin, Texas."

Answered by AI

Is this experiment the first of its kind?

"A search of clinicaltrials.gov reveals that 513 live studies concerning Durvalumab are distributed across 65 nations and 2012 cities. The earliest trial associated with this medication was held in 2005, sponsored by AstraZeneca, which involved 98 patients and ultimately achieved Phase 1 drug approval status. Since then, 313 follow-up trials have been administered."

Answered by AI

Are enrollees still being accepted into this research experiment?

"According to clinicaltrials.gov, this medical trial is actively recruiting patients. The initial posting of the study occurred on August 12th 2019 and was last updated November 8th 2022."

Answered by AI
~16 spots leftby Dec 2024