DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Triciribine and Carboplatin in Ovarian Cancer

Information source: Prescient Therapeutics, Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer

Intervention: Triciribine (Drug); Carboplatin (Drug); Ondansetron (Drug); Dexamethasone (Drug); Granisetron (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Prescient Therapeutics, Ltd.

Official(s) and/or principal investigator(s):
Robert Wenham, MD, Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center

Summary

The main purpose of this study is to see if we can select patients based on their cancer characteristics, to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.

Clinical Details

Official title: Leveraging a Clinico-Genomic Database to Match Patients to a Trial of Triciribine and Carboplatin: Changing Paradigms in Ovarian Cancer Clinical Research

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD)

Secondary outcome:

Overall Response Rate (ORR)

Progression Free Survival (PFS)

Duration of Stable Disease (SD)

Detailed description: A portion of the patient's cancer tissue, previously removed, will be analyzed for a specific protein (phosphorylated BCL-2 antagonist of cell death). If the patient is found to have high levels of this protein in their tumor, they may qualify to be in the study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- At least 18 years of age

- Histologically confirmed, measurable or non-measurable, recurrent or persistent,

platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy.

- At least one prior regimen of chemotherapy, with no maximum number of chemotherapy

cycles

- A serum creatinine ≤ 1. 5 mg% obtained ≤ 2 weeks prior to entry

- Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000

mm^3; absolute neutrophil count ≥ 1500 mm^3; platelets ≥ 100,000 mm^3

- Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine

transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1. 5 mg/dl

- Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2

- Life expectancy of at least 90 days

- The patient should be off chemotherapy, biologic therapy and radiation for 28 days.

- Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity

Criteria (CTC) version 4 Exclusion Criteria:

- Prior TCN-PM therapy

- History of allergic reactions attributed to compounds of similar chemical or biologic

composition to TCN-PM

- Patients must be disease-free of prior invasive malignancies for >2 years with the

exception of basal cell or squamous cell carcinoma of the skin.

- Inability to give informed consent

- Pregnancy

- Corrected QT interval (QTc) prolongation > 450 milliseconds (msec)

Locations and Contacts

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States
Additional Information

Moffitt Cancer Center Clinical Trials website

Starting date: September 2014
Last updated: May 26, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017