← Back to Search

PI3K Inhibitor

Copanlisib (Aliqopa, BAY80-6946) for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to the last patient has completed the 16 weeks of treatment

Awards & highlights

Study Summary

This trial is testing a new drug for patients with Non-Hodgkin's lymphoma who have progressed after standard therapy. The objective is to evaluate the efficacy and safety of the drug. 30 patients will be enrolled in part A and 120 in part B. The trial will also assess the drug's pharmacokinetics and biomarkers, and patient's quality of life.

Eligible Conditions

Non-Hodgkin Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to the last patient has completed the 16 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to the last patient has completed the 16 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to the last patient has completed the 16 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ORR Based on Investigator Assessment-Part A

ORR Based on Investigator Assessment-Part B

Objective Response Rate (ORR) Based on Independent Review-Part A

+1 more

Secondary outcome measures

DOR Based on Investigator Assessment

Duration of Response (DOR) Based on Independent Review

Lymphoma

+4 more

Side effects data

From 2018 Phase 2 trial • 67 Patients • NCT02391116

40%

Hypertension

37%

Diarrhoea

31%

Hyperglycaemia

30%

Nausea

27%

Fatigue

18%

Vomiting

18%

Pyrexia

18%

Cough

16%

Constipation

15%

Decreased appetite

13%

General physical health deterioration

13%

Neutropenia

13%

Headache

13%

Rash

12%

Mouth ulceration

12%

Hypokalaemia

10%

Oedema peripheral

Anaemia

Thrombocytopenia

Muscle spasms

Dry skin

Abdominal pain

Stomatitis

Platelet count decreased

Dyspnoea

Mucosal inflammation

Upper respiratory tract infection

Hyponatraemia

Arthralgia

Tumour pain

Dizziness

Paraesthesia

Productive cough

Pneumonitis

Tachycardia

Paraesthesia oral

Asthenia

Chest pain

Fall

Lymphocyte count decreased

Weight decreased

White blood cell count decreased

Hypoglycaemia

Hypophosphataemia

Pain in extremity

Lipase increased

Chills

Insomnia

Oropharyngeal pain

Haematoma

Hypotension

Death

Lung infection

Pleural effusion

Back pain

Diplopia

Lower respiratory tract infection

Pneumonia pneumococcal

Cancer pain

Neurological symptom

Lymphadenopathy

Febrile neutropenia

Haematuria

Renal failure

Urinary retention

Acute kidney injury

Colitis

Gastrointestinal haemorrhage

Sudden death

Cystitis

Herpes zoster

Thrombophlebitis septic

Urosepsis

Escherichia urinary tract infection

Respiratory tract infection viral

Splenic infection fungal

Hepatic infection fungal

Pneumocystis jirovecii pneumonia

Amylase increased

Blood creatinine increased

Neutrophil count decreased

Cachexia

Dehydration

Hypercalcaemia

Inflammatory carcinoma of the breast

Mycosis fungoides

Acute pulmonary oedema

Stevens-Johnson syndrome

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Copanlisib (Aliqopa, BAY80-6946)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Copanlisib (indolent NHL)Experimental Treatment1 Intervention

Part A: Participants in this arm will be patients with indolent NHL.

Group II: Copanlisib (indolent B-cell NHL)Experimental Treatment1 Intervention

Part B: Participants in this arm will be patients with indolent B-cell NHL.

Group III: Copanlisib (aggressive NHL)Experimental Treatment1 Intervention

Part A: Participants in this arm will be patients with aggressive NHL.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copanlisib (Aliqopa, BAY80-6946)

2018

Completed Phase 2

~380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,235 Previous Clinical Trials

25,325,336 Total Patients Enrolled

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,261,712 Total Patients Enrolled

Frequently Asked Questions

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

In how many states is this research being conducted?

"17 hospitals are currently participating in this study, with locations spanning from Englewood to Port Saint Lucie. To limit patient travel, it is best to select a hospital near you for participation."

Answered by AI

Has the FDA cleared Copanlisib (Aliqopa, BAY80-6946) for public use?

"Although there is some safety data from preclinical studies, Copanlisib (Aliqopa, BAY80-6946) only received a score of 2 because Phase 2 trials have not yet demonstrated efficacy."

Answered by AI

What goals do the researchers hope to achieve with this experiment?

"The primary objective of this study, as measured over the course of 16 weeks of treatment, is ORR Based on Investigator Assessment-Part B. Additionally, the study will assess secondary outcomes including Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score at Week 16 - Part B. FACT-Lym is a questionnaire that covers HRQoL, common lymphoma symptoms and treatment side-effects. It contains 42 items and covers issues such as pain, itching, night sweats, trouble sleeping and fatigue. The score ranges from 0 to 168, with a higher score indicating a better HRQoL"

Answered by AI

What other research is this study similar to?

"As of right now, there are 34 ongoing clinical trials for Copanlisib (Aliqopa, BAY80-6946) in 983 different cities spread across 46 countries. The first study was sponsored by Bayer and took place all the way back in 2012. That particular trial involved 227 patients and completed its Phase 2 drug approval stage. Since then, 19 more studies have been conducted."

Answered by AI

Are we looking for more test subjects at this time?

"This particular clinical trial is not recruiting patients at the moment. The listing was first posted on November 19, 2012 and last updated on November 15, 20212. There are other ongoing studies though: 1792 for lymphoma diffuse and 34 for Copanlisib (Aliqopa, BAY80-6946)."

Answered by AI

What other research has been conducted with Copanlisib?

"Currently, there are 34 ongoing clinical trials studying the efficacy of Copanlisib (Aliqopa, BAY80-6946), 3 of which are in Phase 3. Most of these investigations into Copanlisib (Aliqopa, BAY80-6946) are based out of Houston, Texas; however, there are 2139 locations worldwide where these trials are taking place."

Answered by AI

To what extent is this research being conducted on test subjects?

"Unfortunately, this study is no longer seeking participants. Although it was updated recently on November 15th, 2022, the original posting date was 11/19/2012. There are other ongoing trials that may be of interest; at the moment, there are 1792 lymphoma trials and 34 Copanlisib (Aliqopa, BAY80-6946) trials recruiting patients."

Answered by AI

Recent research and studies

Annals of OncologyJournal

Phase II Study of Copanlisib, a PI3K Inhibitor, in Relapsed or Refractory, Indolent or Aggressive Lymphoma

Dreyling, M., F. Morschhauser, K. Bouabdallah, D. Bron, D. Cunningham, S.E. Assouline, G. Verhoef, et al.. 2017. “Phase II Study of Copanlisib, a PI3K Inhibitor, in Relapsed or Refractory, Indolent or Aggressive Lymphoma”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdx289.

Blood AdvancesJournal

Efficacy and Safety of Copanlisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma

Panayiotidis, Panayiotis, George A. Follows, Luigina Mollica, Arnon Nagler, Muhit Özcan, Armando Santoro, Don Stevens, et al.. 2021. “Efficacy and Safety of Copanlisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002910.

clinicaltrials.govStudy

Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

2012. "Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01660451.