Advanced Cancer
Conditions
Keywords
Advanced cancer
Brief summary
This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.
Interventions
DRUGMKC-1
30 mg and 100 mg capsules, dosed BID daily on a continuous schedule
Sponsors
CASI Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective. * Age greater than or equal to 18 years. * ECOG performance status ≤1 * ANC greater than or equal to 1,500/mm3; * Platelets greater than or equal to 100,000/mm3 * creatinine ≤1.5 times institutional upper limit of normal (ULN) * T Bili within normal limits; * AST and ALT less than or equal to 2.5 times ULN; and * albumin greater than or equal to 3.0 g/dL * have measurable disease by RECIST, radiographically evaluable disease, or detectable disease * women of child-bearing potential and men must agree to use adequate contraception * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Have previously received MKC-1. * Have received radiation to greater than 25% of the bone marrow. * Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Are concurrently receiving any other investigational agents while on study. * Have known brain metastases * Have any condition that impairs the ability to swallow and retain MKC-1 capsules. * Uncontrolled intercurrent illness * Are pregnant or breastfeeding * HIV-positive patients * Patients with uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors. | Throughout study participation |
Secondary
| Measure | Time frame |
|---|---|
| Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement. | During study participation |
Countries
United States
Outcome results
None listed