Suspended

Pivanex Treatment for Malignant Melanoma

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What is being tested

Data Collection

Who is being recruted

Melanoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorTitan Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2004

Actual date on which the first participant was enrolled.

This study focuses on a drug called Pivanex, which is a histone deacetylase inhibitor. This type of drug helps to slow down or stop the growth of cancer cells and has shown promising results in non-small cell lung cancer. Now, researchers want to see if it can also help patients with malignant melanoma, a serious type of skin cancer. The goal is to find new ways to treat this disease, especially for those who have not responded well to chemotherapy or Interleukin-2 (IL-2). In this study, participants will receive Pivanex through an intravenous (IV) line, which is a small tube inserted into a vein, over a period of 6 hours for 3 days. This treatment cycle will be repeated every 21 days until the cancer progresses or the patient is withdrawn from the study for other reasons. The response to the treatment will be checked before every odd-numbered cycle using a method called the Response Evaluation Criteria in Solid Tumors (RECIST). The study will measure how long it takes for the disease to progress, overall survival, and the safety of using Pivanex for malignant melanoma.

Official TitleA Pilot Study of Pivanex, a Histone Deacetylase Inhibitor, in Patients With Malignant Melanoma
Principal SponsorTitan Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

11 inclusion criteria required to participate
Measurable disease.

Recurrent or progressive disease after treatment.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histologically or cytologically confirmed melanoma, previously treated with chemotherapy or IL-2

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9 exclusion criteria prevent from participating
Known HIV-positive patients.

Acute medical problems, such as ischemic heart or lung disease or uncontrolled systemic infection.

Patients with any underlying medical conditions or circumstance, which would contraindicate therapy with study treatment, affect compliance or impair evaluation of study endpoints.

Patients receiving investigational agents within 4 weeks of randomization.

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Mt. Sinai Comprehensive Cancer Center

Miami Beach, United StatesOpen Mt. Sinai Comprehensive Cancer Center in Google Maps
SuspendedOne Study Center