PTX-200 and Carboplatin in Ovarian Cancer

Tracking Information
First Submitted Date ICMJE	September 19, 2012
First Posted Date ICMJE	September 21, 2012
Last Update Posted Date	January 12, 2018
Actual Study Start Date ICMJE	September 2014
Estimated Primary Completion Date	December 2018 (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	Complete list of historical versions of study NCT01690468 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 1; Phase 2
Study Design ICMJE	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	Experimental: Triciribine and Carboplatin Treatment (TCN); Phase I/II: 25mg/m^2 Triciribine and Carboplatin AUC 5. 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	Recruiting
Estimated Enrollment ICMJE; (submitted: August 6, 2016)	36
Original Estimated Enrollment ICMJE; (submitted: September 20, 2012)	45
Estimated Study Completion Date	December 2018
Estimated Primary Completion Date	December 2018 (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	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Mandeep Grewal mandeep@ptxtherapeutics.com
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01690468
Other Study ID Numbers ICMJE	MCC-17035
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Undecided
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	January 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP