PTX-200 and Carboplatin in Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT01690468
• Recruitment Status: Terminated
• First Posted: September 21, 2012
• Last Update Posted: September 24, 2020
• Sponsor: Prescient Therapeutics, Ltd.
• Information provided by (Responsible Party): Prescient Therapeutics, Ltd.

Tracking Information

• First Submitted Date: September 19, 2012
• First Posted Date: September 21, 2012
• Last Update Posted Date: September 24, 2020
• Actual Study Start Date: September 2014
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2012)

Maximum Tolerated Dose (MTD) [ Time Frame: 6 months ]

To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 20, 2012)

• Overall Response Rate (ORR) [ Time Frame: 2 years ]
  The best overall response is the best time point response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest sum recorded since baseline). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
• Progression Free Survival (PFS) [ Time Frame: 2 years ]
  Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
• Duration of Stable Disease (SD) [ Time Frame: 2 years ]
  Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. Response and progression will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST version 1-1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ovarian Cancer

Intervention

• Drug: 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.
  Other Names:

  • triciribine phosphate monohydrate
  • TCN
  • TCN-PM
  • AKT inhibitor
• Drug: Carboplatin
  Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.
  Other Names:

  • Paraplatin®
  • NSC #241240

Study Arms

Experimental: 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.

Interventions:

• Drug: Triciribine
• Drug: Carboplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 17, 2020): 15
• Original Estimated Enrollment (submitted: September 20, 2012): 45
• Actual Study Completion Date: December 2019
• Actual Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01690468
• Other Study ID Numbers: MCC-18641
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Prescient Therapeutics, Ltd.
• Study Sponsor: Prescient Therapeutics, Ltd.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert Wenham, MD; H. Lee Moffitt Cancer Center

• PRS Account: Prescient Therapeutics, Ltd.
• Verification Date: September 2020