CompletedPhase 1

A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors

United States48 participantsStarted 2012-10

Plain-language summary

In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males / females, ≥ 18 years old, any race / ethnicity, who can provide written Informed Consent * Life expectancy ≥ 3 months * Pathologically confirmed solid tumor, locally advanced / metastatic, refractory after standard therapy, or for which no effective curative or surgical treatment options are available * Measurable disease on baseline imaging per RECIST 1.1 criteria * ECOG performance status ≤ 1 * Liver function: * Bilirubin ≤ 1.5 X upper limit of normal * AST, SGOT, ALT, SGPT ≤ 2.5 X upper limit of normal, \< 5 upper limit if there are liver metastases * Renal function: * Serum creatinine within normal limits * Hematologic status: * Absolute neutrophil count ≥ 1500 cells/mm3. * Platelet count ≥ 100,000/mm3. * Hemoglobin ≥ 9 g/dL * Coagulation status: * Coagulation Prothrombin time ≤ 1.5 X upper limit * Partial thromboplastin time ≤ 1.5 X upper limit * Males must agree to use condoms during sex to prevent spillage of semen for the duration of the study and for 3 months after the patient leaves the study * Females in the study must not be pregnant or breast feeding and not planning to become pregnant or breast feed for the duration of the study, and for at least three months after study completion * Women of childbearing potential must commit to using a double barrier method of contraception, an intrauterine device, or sexual abstinence for the duration of the study and for at least three months after study completion * Serum pregnancy test for wom…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Tolerated Dose (MTD) of Kevetrin

Timeframe: up to 6 months

Dose Limiting Toxicities (DLT) of Kevetrin.

Timeframe: up to 4 weeks

Trial details

NCT IDNCT01664000

SponsorCellceutix Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

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