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Anti-tumor antibiotic

Oraxol for Stomach Cancer

Phase 1

Waitlist Available

Research Sponsored by Athenex, Inc.

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 one month

Awards & highlights

Study Summary

This trial is testing a new cancer drug (Oraxol) to see what the maximum tolerated dose is when combined with another cancer drug (ramucirumab).

Eligible Conditions

Stomach Cancer
Esophageal Cancer
Gastroesophageal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ investigator,telephone, or family member contact or public records access will be performed every 3 months for the purpose of assessing overall survival.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~investigator,telephone, or family member contact or public records access will be performed every 3 months for the purpose of assessing overall survival.

This trial's timeline: 3 weeks for screening, Varies for treatment, and investigator,telephone, or family member contact or public records access will be performed every 3 months for the purpose of assessing overall survival. 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)

Secondary outcome measures

Preliminary activity of Oraxol plus ramucirumab as determined by overall survival

Preliminary activity of Oraxol plus ramucirumab as determined by progression-free survival

Preliminary activity of Oraxol plus ramucirumab as determined by response rate

+10 more

Side effects data

From 2018 Phase 1 trial • 28 Patients • NCT03165955

57%

Diarrhoea

57%

Neutropenia

43%

Alopecia

32%

Nausea

21%

Anaemia

18%

Alanine aminotransferase increased

18%

Aspartate aminotransferase increased

14%

Neuropathy peripheral

14%

Decreased appetite

14%

Vomiting

11%

Haemorrhoids

11%

Leukopenia

Peripheral sensory neuropathy

Urinary tract infection

Fatigue

Insomnia

White blood cell count decreased

Hypoalbuminaemia

Hyponatraemia

Dizziness

Malaise

Upper respiratory tract infection

Blood lactate dehydrogenase increased

Hypoaesthesia

Abdominal pain upper

Mouth ulceration

Pruritus

Rash maculo-papular

Hepatitis acute

Pneumonia

Septic shock

Femur fracture

Infected neoplasm

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Oraxol (Oral Paclitaxel Plus HM30181)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oraxol +RamucirumabExperimental Treatment2 Interventions

Oraxol (oral HM30181 + oral paclitaxel) HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets Paclitaxel - supplied as 30-mg capsules Ramucirumab - supplied as a solution at a concentration of 10 mg/mL

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oraxol

2018

Completed Phase 3

~620

Ramucirumab

2017

Completed Phase 3

~5050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Athenex, Inc.Lead Sponsor

26 Previous Clinical Trials

1,932 Total Patients Enrolled

David Cutler, MDStudy DirectorAthenex, Inc.

10 Previous Clinical Trials

639 Total Patients Enrolled

Frequently Asked Questions

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

Is this medical experiment seeking to enroll participants at this time?

"Confirmatory information sourced from clinicaltrials.gov indicates that this trial has ceased its recruitment activities, with the initial posting being on December 8th 2016 and the most recent update recorded on February 15th 2022. However, there are still 1,565 other trials actively recruiting at present."

Answered by AI

How many participants are included in this research endeavor?

"This trial is unfortunately no longer enrolling patients. The post was initially published in December 8th 2016 and the last edit was made on February 15th 2022. If you seek other medical studies, there are currently 705 trials for gas chromatography and 860 clinical trials for Oraxol that are actively recruiting participants."

Answered by AI

What medical conditions are usually treated with Oraxol?

"Oraxol has shown efficacy in treating neoplasm metastasis, Kaposi sarcoma, and advance directives."

Answered by AI

Has the Food and Drug Administration approved Oraxol for use yet?

"Our team evaluated Oraxol's safety as a 1 since it is currently being tested in Phase 1 trials, meaning there only exists limited data supporting its efficacy and protective qualities."

Answered by AI

Are there any prior investigations involving Oraxol?

"At present, 860 different trials are being conducted that involve Oraxol. Of these trials, 231 have advanced to the third phase of clinical research. While there is only one primary site in Woolloongabba, Queensland for conducting such studies, a total of 47 399 sites globally are hosting them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers

2016. "Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02970539.

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