Clinical trial NCT01690468: PTX-200 and Carboplatin in Ovarian Cancer
Official title: A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Prescient Therapeutics, Ltd.
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is 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.

Detailed description: The purpose of this study is to investigate the safety and tolerability, and determine the maximum tolerated dose of triciribine when combined with carboplatin in women with platinum-resistant, recurrent or persistent ovarian cancer. The secondary objectives are to evaluate the clinical activity of carboplatin plus triciribine in women with recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate, progression-free survival, and duration of stable disease.

Eligibility 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)

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 6 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 2 years
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Duration of Stable Disease (SD)
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center
name: Robert Wenham, MD
role: PRINCIPAL_INVESTIGATOR
References: