PTX-200 and Carboplatin in Ovarian Cancer

NCT ID: NCT01690468

Last Updated: 2020-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triciribine & Carboplatin

Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 4. Triciribine escalated to 30, 35, 45mg/m^2 if toxicities are not encountered.

Phase II: Recommended phase II dose of triciribine and carboplatin.

Group Type: EXPERIMENTAL

Triciribine

Intervention Type: DRUG

Triciribine (15, 25, 30, 35, or 45 mg/m\^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.

Carboplatin

Intervention Type: DRUG

Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.

Interventions

Triciribine

Triciribine (15, 25, 30, 35, or 45 mg/m\^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.

Intervention Type: DRUG

Carboplatin

Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.

Intervention Type: DRUG

Other Intervention Names

triciribine phosphate monohydrate; TCN; TCN-PM; AKT inhibitor; Paraplatin®; NSC #241240

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prescient Therapeutics, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Wenham, MD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-18641

Identifier Type: -

Identifier Source: org_study_id