APG-115 for Salivary Gland Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Salivary Gland Cancers+2 More
APG-115 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Salivary Gland Cancers
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Until death or end of study; up to approximately 5 years

42 days
Maximally tolerated dose (MTD)
Primary Toxicity Endpoint: dose-limiting toxicity (DLT)
Year 5
Disease control rate
Duration of response
Overall response rate by tumor histology
Overall survival
Progression-free survival
up to 12 months
Overall response rate

Trial Safety

Side Effects for

Chemotherapy
58%Neutropenia
45%Nausea
36%Fatigue
34%Alopecia
30%Constipation
30%Vomiting
28%Anaemia
24%Thrombocytopenia
19%Abdominal pain
19%Diarrhoea
18%Drug hypersensitivity
16%Leukopenia
14%Asthenia
12%Pruritus
11%Headache
9%Bone pain
9%Rash
8%Dizziness
8%Oedema peripheral
8%Dyspepsia
8%Myalgia
7%Dysgeusia
7%Phlebitis
7%Insomnia
7%Dyspnoea
7%Pain in extremity
5%Decreased appetite
5%Peripheral sensory neuropathy
5%Abdominal distension
5%Arthralgia
5%Cough
5%Neuropathy peripheral
5%Paraesthesia
4%Back pain
4%Febrile neutropenia
4%Stomatitis
4%Pyrexia
4%Epistaxis
3%Lethargy
3%Abdominal pain upper
3%Nasopharyngitis
3%Flushing
3%Musculoskeletal pain
3%Urinary tract infection
3%Erythema
1%Obstruction
1%Large intesting perforation
1%Hemorrhoids
1%Chest pain
1%Dry skin
1%Appendicitis
1%Pulmonary embolism
1%Dehydration
1%Ascites
1%Sinusitis
1%Muscle spasms
1%Mucosal inflammation
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT02004093) in the Chemotherapy ARM group. Side effects include: Neutropenia with 58%, Nausea with 45%, Fatigue with 36%, Alopecia with 34%, Constipation with 30%.

Trial Design

2 Treatment Groups

APG-115 + Carboplatin [terminated]
1 of 2
APG-115 monotherapy
1 of 2

Experimental Treatment

34 Total Participants · 2 Treatment Groups

Primary Treatment: APG-115 · No Placebo Group · Phase 1 & 2

APG-115 + Carboplatin [terminated]Experimental Group · 2 Interventions: Carboplatin, APG-115 · Intervention Types: Drug, Drug
APG-115 monotherapy
Drug
Experimental Group · 1 Intervention: APG-115 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
APG-115
2016
Completed Phase 1
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: until death or end of study; up to approximately 5 years

Who is running the clinical trial?

Ascentage Pharma Group Inc.Industry Sponsor
40 Previous Clinical Trials
2,768 Total Patients Enrolled
University of Michigan Rogel Cancer CenterLead Sponsor
264 Previous Clinical Trials
17,868 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
17 Previous Clinical Trials
1,237 Total Patients Enrolled
Paul L Swiecicki, MDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a performance status of ≤ 1.
You have measurable disease by CT scan per RECIST v1.
You have signed and dated an informed consent document indicating that you have been informed of all pertinent aspects of the trial prior to enrollment.
You are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
You are able to take oral medication without breaking, crushing, dissolving, or chewing capsules.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.