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Histone Deacetylase Inhibitor

HBI-8000 in combination with nivolumab for Kidney Cancer

Phase 1 & 2

Waitlist Available

Led By Nikhil I Khushalani, MD

Research Sponsored by HUYA Bioscience International

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 18 months

Awards & highlights

Study Summary

This trial is testing a new drug, HBI-8000, in combination with the existing drug nivolumab, to see if it is safe and effective in treating advanced solid tumors, including melanoma, renal cell carcinoma, and non-small cell lung cancer.

Eligible Conditions

Kidney Cancer
Non-Small Cell Lung Cancer
Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determination of the Recommended for Phase 2 Dose (RP2D) (mg)

Secondary outcome measures

Efficacy Outcome: Response Rate (%).

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

Nausea

54%

Anaemia

51%

Fatigue

39%

Decreased appetite

36%

Malignant neoplasm progression

32%

Constipation

31%

Diarrhoea

30%

Cough

29%

Vomiting

29%

Dyspnoea

25%

Oedema peripheral

24%

Back pain

21%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Hypertension

Bronchitis

Dehydration

Hyperglycaemia

Hyperkalaemia

Blood alkaline phosphatase increased

Chills

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Malignant pleural effusion

Sepsis

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Syncope

Cancer pain

Neoplasm progression

Pneumothorax

Atrial flutter

Bone pain

Pericardial effusion malignant

Circulatory collapse

Confusional state

Hypercalcaemia

Femur fracture

Bronchial obstruction

Superior vena cava syndrome

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

Study treatment Arm

Investigator Choice of Chemotherapy

Post Chemotherapy Optional Nivolumab

Nivolumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: HBI-8000 in combination with nivolumabExperimental Treatment1 Intervention

HBI-8000 dose escalation 20mg, 30mg, 40mg, orally, twice weekly; in combination with Nivolumab 240mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institution's prescribing practice for Phase 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HBI-8000 in combination with nivolumab

2016

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

HUYA Bioscience InternationalLead Sponsor

8 Previous Clinical Trials

792 Total Patients Enrolled

HUYABIO International, LLC.Lead Sponsor

11 Previous Clinical Trials

883 Total Patients Enrolled

Nikhil I Khushalani, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL

2 Previous Clinical Trials

53 Total Patients Enrolled

Frequently Asked Questions

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

Could you outline the research that has been conducted on HBI-8000 and its synergy with nivolumab?

"Presently, there are 765 active clinical trials for HBI-8000 in combination with nivolumab. Of these, 86 have reached the third phase of testing while 40343 locations across the world are conducting studies related to this drug combo. The majority of these trails can be found in Beijing."

Answered by AI

What is the participant count of this trial?

"Unfortunately, this research endeavour is not currently recruiting. The study was first registered on August 1st 2016 and it's most recent update occurred October 12th 2022. If you are seeking other clinical trials for melanoma, there are 4944 studies that are presently enrolling patients; similarly, 765 medical experiments related to HBI-8000 in combination with nivolumab have open recruitment slots available now."

Answered by AI

Are applications for this trial still being accepted?

"This investigation has stopped accepting participants. It was first posted on August 1st 2016 and last updated October 12th 2022. Alternately, there are 4944 trials recruiting melanoma patients and 765 studies searching for individuals to participate in the HBI-8000 + nivolumab trial."

Answered by AI

Has a trial of this type been implemented before?

"Since 2012, the potential of HBI-8000 in conjunction with nivolumab has been studied. The initial study was led by Ono Pharmaceutical Co. Ltd and embraced 659 participants. After passing Phase 1 & 2 trials, additional research continues to be conducted around the world - there are presently 765 operational studies involving this drug combination taking place across 2359 cities from 49 nations."

Answered by AI

In what geographic locations is this research endeavor taking place?

"Presently, 6 medical centres are hosting this clinical trial. These locations can be found in Phoenix, Frederick and La Jolla as well as 3 other places. To reduce the amount of travelling required by participants, it is likely best to select a site closest to them."

Answered by AI

In what medical cases is the pairing of HBI-8000 and nivolumab most frequently prescribed?

"HBI-8000 in conjunction with nivolumab is often prescribed to people afflicted by malignant neoplasms. Additionally, it can be useful for individuals struggling with unresectable melanoma, squamous cell carcinomas, and metastatic esophageal adenocarcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

2016. "Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02718066.