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PTX-200 and Carboplatin in Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01690468
Recruitment Status : Terminated (Enrollment stopped prior to Phase 1b, change in strategic focus)
First Posted : September 21, 2012
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.

Tracking Information
First Submitted Date  ICMJE September 19, 2012
First Posted Date  ICMJE September 21, 2012
Last Update Posted Date September 24, 2020
Actual Study Start Date  ICMJE September 2014
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PTX-200 and Carboplatin in Ovarian Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 17, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2012)
45
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01690468
Other Study ID Numbers  ICMJE MCC-18641
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prescient Therapeutics, Ltd.
Study Sponsor  ICMJE Prescient Therapeutics, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Wenham, MD H. Lee Moffitt Cancer Center
PRS Account Prescient Therapeutics, Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP