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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TaiRx, Inc.

Criteria

Inclusion Criteria:

1. Tumor eligibility:

Histologically or cytologically confirmed advanced malignancies, which is refractory to standard of care therapy, or for whom no standard of care therapy is available.

2. Solid tumors must have measurable or evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1). Target lesions that have been previously irradiated will not be considered measurable (lesion) unless increase in size is observed following completion of radiation therapy. Lymphomas must have measurable disease as per Revised Response Criteria for Malignant Lymphomas.

3. ECOG performance status 0 to 2. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade 1 (except alopecia).

4. Adequate organ function as defined by the following criteria:

1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy

2. Total serum bilirubin ≤1.5 x ULN (except for patients with documented Gilbert's syndrome)

3. Absolute neutrophil count (ANC) 1,500/µL

4. Platelets 90,000/µL

5. Hemoglobin 9.0 g/dL

6. Serum creatinine ≤1.5 x ULN or creatinine clearance of ≥ 60 mL/min

5. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the study prior to enrollment.

6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Patients presenting with any of the following will not be included in the study:

1. Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of starting study treatment.

2. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue except for patients with lymphoma

3. Current treatment on another clinical study.

4. Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 4 weeks.

2. Any of the following within 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack; within 6 months prior to starting study treatment for pulmonary embolus. However, upon agreement between the investigator and sponsor, the 6-month post-event-free period for a patient with a pulmonary embolus can be waived if due to advanced cancers. Appropriate treatment with anticoagulants is permitted.

3. Hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy).

4. Current treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg PO daily is allowed).

5. Known human immunodeficiency virus infection.

6. Hepatitis B virus (HBV) or hepatitis C virus (HCV) with evidence of chronic active disease or receiving/requiring antiviral therapy.

7. History of receiving organ transplantation or immune disorders that require continuous immunosuppressant agent therapy.

8. Pregnancy or breastfeeding. Female patients must be surgically sterile or be post-menopausal or must agree to the use of effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

9. Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study.