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MDM2 Inhibitor

APG-115 +/- Carboplatin for Salivary Gland Cancer

Phase 1 & 2
Waitlist Available
Led By Paul L Swiecicki, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Patients must be able to take oral medication without breaking/opening, crushing, dissolving, or chewing capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death or end of study; up to approximately 5 years
Awards & highlights

Study Summary

This trial is for a new treatment of cancer in the salivary gland. It is testing a new drug, APG-115, with or without another drug, Carboplatin. Part 1 had 2 groups, but one group did not have the new drug APG-115 and was not doing well, so that group was stopped. Part 2 is just testing APG-115 by itself.

Who is the study for?
This trial is for adults with malignant salivary gland cancer that can't be cured by surgery or other treatments, or they've refused such treatments. They should have no p53 gene mutations, be in good physical condition (ECOG ≤1), and have a life expectancy of at least 12 weeks. Participants must not have had recent cancer therapy and must agree to use two forms of contraception.Check my eligibility
What is being tested?
The study is testing the effectiveness of APG-115 alone for treating p53 wild-type malignant salivary gland cancer. The first part included an additional arm with APG-115 plus Carboplatin but was stopped early; now it's just focusing on APG-115 as a single agent.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with similar medications include nausea, fatigue, blood count changes, risk of infection due to weakened immune system, liver function alterations, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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I can swallow pills without needing to break or crush them.
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I have a salivary gland cancer that cannot be cured, or I have refused curative treatment.
Select...
My cancer has grown by at least 20% in the last year, confirmed by a CT scan.
Select...
My cancer does not have a p53 mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or end of study; up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death or end of study; up to approximately 5 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
Maximally tolerated dose (MTD)
Overall response rate
Primary Toxicity Endpoint: dose-limiting toxicity (DLT)
Secondary outcome measures
Disease control rate
Duration of response
Overall response rate by tumor histology
+2 more

Side effects data

From 2008 Phase 2 trial • 149 Patients • NCT02004093
59%
Nausea
59%
Diarrhoea
48%
Neutropenia
40%
Fatigue
32%
Vomiting
29%
Alopecia
27%
Constipation
25%
Anaemia
25%
Decreased appetite
24%
Abdominal pain
23%
Rash
21%
Headache
19%
Epistaxis
15%
Drug hypersensitivity
15%
Arthralgia
15%
Thrombocytopenia
15%
Neuropathy peripheral
13%
Stomatitis
13%
Dysgeusia
12%
Asthenia
12%
Dizziness
12%
Dyspepsia
12%
Leukopenia
11%
Dyspnoea
11%
Nail disorder
11%
Peripheral sensory neuropathy
9%
Mucosal inflammation
9%
Pruritus
9%
Muscle spasms
9%
Cystitis
8%
Insomnia
8%
Hemorrhoids
8%
Back pain
8%
Hypertension
8%
Pain in extremity
8%
Urinary tract infection
7%
Cough
7%
Flushing
7%
Nasopharyngitis
7%
Myalgia
7%
Musculoskeletal pain
7%
Erythema
7%
Bone pain
7%
Abdominal pain upper
7%
Chest pain
7%
Pyrexia
5%
Dry skin
5%
Lethargy
5%
Paraesthesia
5%
Abdominal pain lower
5%
Vaginal discharge
5%
Oedema peripheral
4%
Phlebitis
3%
Intestinal obstruction
1%
Abdominal distension
1%
Ascites
1%
Gastrointestinal haemorrhage
1%
Local swelling
1%
Pulmonary embolism
1%
Diaphragmatic hernia
1%
Cardiac failure congestive
1%
Hepatic lesion
1%
Blood glucose increased
1%
Lower respiratory tract infection
1%
Pneumonia
1%
Syncope
1%
Ileus paralytic
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy + Pertuzumab
Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Group I: APG-115 monotherapyExperimental Treatment1 Intervention
APG-115 will be administered in an open label fashion until progression, intolerance, or patient preference.
Group II: APG-115 + Carboplatin [terminated]Experimental Treatment2 Interventions
APG-115 and Carboplatin will be administered in an open label fashion until progression, intolerance, or patient preference. [Phase 1 was terminated early and this arm was discontinued. An MTD was not established during Phase 1.]
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
APG-115
2016
Completed Phase 1
~50
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,087 Total Patients Enrolled
Ascentage Pharma Group Inc.Industry Sponsor
46 Previous Clinical Trials
4,300 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,272 Total Patients Enrolled

Media Library

APG-115 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03781986 — Phase 1 & 2
Salivary Gland Cancer Clinical Trial 2023: APG-115 Highlights & Side Effects. Trial Name: NCT03781986 — Phase 1 & 2
APG-115 (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03781986 — Phase 1 & 2

Frequently Asked Questions

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

Are there any other research efforts that have investigated the effectiveness of APG-115?

"First studied in 2002 at Bristol Royal Hospital for Children, APG-115 has been the subject of 835 completed studies. Currently, there are 702 ongoing clinical trials taking place around Tampa, Florida."

Answered by AI

What are the primary goals of this research project?

"The primary aim of this 12 month study is to ascertain the dose-limiting toxicity (DLT) that may be associated with this medication. Secondary objectives such as duration of response, overall response rate by tumour histology and patient's overall survival are also being calculated."

Answered by AI

What is the typical application of APG-115?

"APG-115 is a common medication utilized to combat non-Hodgkin lymphoma, as well as advanced sarcoma and Hodgkin disease in its initial stages."

Answered by AI

What is the uppermost limit on participants in this investigation?

"This clinical trial requires 34 qualified participants to take part in the study. Qualifying individuals can find enrolment centres located at the Moffitt Cancer Center in Tampa, Florida and University of Michigan Rogel Cancer Centre in Chicago, Illinois."

Answered by AI

Is this medical research project currently enrolling patients?

"According to the information on clinicaltrials.gov, this experiment has been ongoing since its listing on October 28th 2019 and is actively recruiting volunteers. The entry was most recently updated February 10th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
APG-115 in Salivary Gland Cancer Trial
2019. "APG-115 in Salivary Gland Cancer Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03781986.
~1 spots leftby Jul 2024
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