KX-ORATOP-001 A Dose Regimen-Finding Study
Research type
Research Study
Full title
A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oral Topotecan with HM30181A Monotherapy in Patients with Advanced Malignancies.
IRAS ID
252796
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
Athenex Inc.
Eudract number
2018-003846-17
Clinicaltrials.gov Identifier
U1111-1192-3119, Universal Trial Number (UTN) Number
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This research study is being conducted to determine the maximum tolerated dose (MTD) of oral topotecan in combination with 15mg HM30181A tablet in patients who have cancer, for which topotecan chemotherapy would be an appropriate treatment. HM30181A is a novel P-glycoprotein (P-gp) inhibitor that may increase the bioavailability of orally administered drugs which are substrates of P-gp, such as oral topotecan. Bioavailability is defined as the amount of drug that has been absorbed into the blood after a drug dose being administered orally.
The study also aims to determine whether the oral topotecan with HM30181A is safe and well tolerated treatment in this patient population and whether it exerts clinical activity by evaluating tumour response. Finally, the study will look at what the body does to the drug by taking and examining blood samples and comparing bioavailability of oral topotecan with or without the HM30181A tablet.
The study will take approximately 24 months and it will include a 7-day Lead-in Period and a Treatment Period. In the Lead-in Period, patients will receive a single oral topotecan dose of 2.3 mg/m2. During the Treatment Period, a so-called 3+3 dose escalation study will be conducted to determine the MTD of oral topotecan with 15 mg HM30181A tablet administered once daily for 5 consecutive days over 21-day treatment cycles. The MTD will be the highest dose at which no more than 1 of 6 patients experience unacceptable toxicities in treatment cycle 1. Briefly, 3 patients will receive the starting topotecan dose of 0.5 mg/m2 once daily for 5 consecutive days given every 21 days. After all patients complete cycle 1 and no unacceptable toxicities are observed, the doses will be increased by 0.25 mg/m2 increments in subsequent dose cohorts consisting of 3 more patients.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0135
Date of REC Opinion
27 Jun 2019
REC opinion
Further Information Favourable Opinion