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
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