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PTX-200 and Carboplatin in Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01690468
Recruitment Status : Recruiting
First Posted : September 21, 2012
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Triciribine Drug: Carboplatin Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Actual Study Start Date : September 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
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.

 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690468


Contacts
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Contact: Claudia Gregorio-King claudia@ptxtherapeutics.com

Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Denise Dorman    813-745-7272    denise.dorman@moffitt.org   
Sub-Investigator: Sachin Apte, M.D.         
Principal Investigator: Robert M. Wenham, M.D.         
Sub-Investigator: Mian Shahzad, M.D., Ph.D.         
Sponsors and Collaborators
Prescient Therapeutics, Ltd.
Investigators
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Principal Investigator: Robert Wenham, MD H. Lee Moffitt Cancer Center
More Information
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Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

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Responsible Party: Prescient Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT01690468     History of Changes
Other Study ID Numbers: MCC-18641
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carboplatin
Antineoplastic Agents