NCT04336124

Safety and Pharmacokinetic Study of CVM-1118 Extended-Release in Advanced Cancer Patients

A Phase I Safety and Pharmacokinetic Study of CVM-1118 Extended-Release Capsules Administered Orally to Patients With Advanced Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: TaiRx, Inc. · Industry
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

CVM-1118 Immediate-release (IR) Capsule and CVM-1118 Extended-release (ER) Capsule are proprietary oncology products developed by TaiRx, Inc. for the treatment of patients suffering from advanced cancer. Due to the short elimination half-life of CVM-1118 IR capsules, the extended release (ER) formulation, containing mini-tablets in hard capsule, has been developed to prolong the drug absorption and longer exposure after oral administration. The designed dose of CVM-1118 ER was 200 mg per capsule to provide a more patient-compliant and safe dosage of CVM-1118. The clinical study CVMEX-001 is therefore designed to evaluate the safety and pharmacokinetics of CVM-1118 extend release (ER) Capsule (200 mg/capsule) in patients with advanced cancer.

Detailed description

The CVM-1118 ER Capsule will be orally administered BID or TID before meal in 28-day treatment cycles. Patients will receive 400, 600, 800 to 1,200 mg of CVM-1118 ER Capsule in sequential cohort based on safety and dose tolerability. A single-patient cohort per dose level (accelerated titration design) will be applied to the first two cohorts, 400 and 600 mg daily, and followed by the conventional 3+3 dose escalation design from the dose level of 800 mg/day. Within the first two cohorts, if any Grade 2 or greater toxicity at least possibly attributable to CVM-1118 ER capsule is reported in the first patient during first cycle, a single-patient cohort will be converted to conventional 3+3 study design once and expand to a minimum of 3 evaluable patients for assessment of toxicity within the first cycle. Dose escalation will occur until DLT occurs in 2 or more patients within a dose level. In any cohort, if 1 patient experiences a DLT, 3 additional patients will be enrolled to that dose level. If 2 or more patients experience a DLT, no further dose escalation will occur. Plasma pharmacokinetics samples will be collected at pre-determined time-points for all patients participating in the dose-escalation study. This study will be completed and closed once the MTD is determined for CVM-1118 ER capsules. However, at the end of 4 cycles, it is recommended that some patients should continue receiving the clinical benefit from CVM-1118 ER capsules. Thus, patients may be continuously treated at the assigned dose level or next higher dose level provided it has been shown to be safe in a previously treated cohort by safety committee, until the treating physician feels the patient is no longer benefiting from the treatment, or CVM-1118 ER Capsule becomes commercially available, as applicable in the country in which the patient lives. In the event of unacceptable toxicity at a given dose, CVM-1118 can be reduced to the previous dose level or suggested lower dose by PI. If unacceptable toxicity persists despite 2 dose reductions, the patient should be removed from study.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	CVM-1118 Extended-Release (ER) Capsules (200 mg/capsule)	Patients will receive initial dose regimen: 400 mg of CVM-1118 ER Capsule per day (200 mg BID) in a 28-day cycle for 4 cycles. Dose escalates from 400, 600, 800, to 1200 mg of CVM-1118 ER capsules with either BID or TID dosing. A single-patient cohort per dose level (accelerated titration design) will be applied to the first two cohorts, 400 and 600 mg daily, and followed by the conventional 3+3 dose escalation design from the dose level of 800 mg/day. If 2 or more patients experience a DLT, no further dose escalation will occur.

Timeline

• Start date: 2020-05-25
• Primary completion: 2021-02-08
• Completion: 2022-04-08
• First posted: 2020-04-07
• Last updated: 2022-11-28

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study