PTX-200 and Carboplatin in Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Prescient Therapeutics, Ltd.
Sponsor:
Information provided by (Responsible Party):
Prescient Therapeutics, Ltd.
ClinicalTrials.gov Identifier:
NCT01690468
First received: September 19, 2012
Last updated: August 6, 2016
Last verified: August 2016
  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.

Condition Intervention Phase
Ovarian Cancer
Drug: Triciribine
Drug: Carboplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Prescient Therapeutics, Ltd.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • Overall Response Rate (ORR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 36
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triciribine and Carboplatin Treatment (TCN)

Phase I/II Clinical Trial Doses: The starting dose for this phase I study (dose level 1) will be TCN 15 mg/m^2 on days 1, 8 and 15, and Carboplatin Area Under the Curve (AUC) 5. TCN will be escalated to 25, 30, 35, then 45 mg/m^2 if dose limiting toxicities (DLTs) are not encountered.

Phase II: Treat 18 additional patients at the recommended Phase II dose of triciribine + carboplatin to confirm safety and tolerability and assess Response Rate and Progression Free Survival (PFS).

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690468

Contacts
Contact: Mandeep Grewal mandeep@ptxtherapeutics.com

Locations
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
Principal Investigator: Robert Wenham, MD H. Lee Moffitt Cancer Center
  More Information

Additional Information:
Responsible Party: Prescient Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT01690468     History of Changes
Other Study ID Numbers: MCC-17035 
Study First Received: September 19, 2012
Last Updated: August 6, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 25, 2016