Clinical Trials /

PTX-200 and Carboplatin in Ovarian Cancer

NCT01690468

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: MCC-18641
  • NCT ID: NCT01690468

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
Triciribinetriciribine phosphate monohydrate, TCN, TCN-PM, AKT inhibitorTriciribine & Carboplatin
CarboplatinParaplatin®, NSC #241240Triciribine & Carboplatin

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Triciribine & CarboplatinExperimentalPhase 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.
  • Triciribine
  • Carboplatin

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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD)
Time Frame:6 months
Safety Issue:
Description: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).

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:2 years
Safety Issue:
Description: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.
Measure:Progression Free Survival (PFS)
Time Frame:2 years
Safety Issue:
Description: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.
Measure:Duration of Stable Disease (SD)
Time Frame:2 years
Safety Issue:
Description: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.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Prescient Therapeutics, Ltd.

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