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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

No Placebo-Only Group

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum tolerated dose (MTD)

Secondary study objectives

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

Dizziness

Hypoaesthesia

Urinary tract infection

Fatigue

Hypoalbuminaemia

Blood lactate dehydrogenase increased

White blood cell count decreased

Peripheral sensory neuropathy

Upper respiratory tract infection

Malaise

Hyponatraemia

Insomnia

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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