Triciribine and Carboplatin in Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborators:
Cahaba Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01690468
First received: September 19, 2012
Last updated: September 23, 2014
Last verified: September 2014

September 19, 2012
September 23, 2014
September 2014
October 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01690468 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
Triciribine and Carboplatin in Ovarian Cancer
Leveraging a Clinico-Genomic Database to Match Patients to a Trial of Triciribine and Carboplatin: Changing Paradigms in Ovarian Cancer Clinical Research

The main purpose of this study is to see if we can select patients based on their cancer characteristics, 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.

A portion of the patient's cancer tissue, previously removed, will be analyzed for a specific protein (phosphorylated BCL-2 antagonist of cell death). If the patient is found to have high levels of this protein in their tumor, they may qualify to be in the study.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • 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
  • Drug: Ondansetron
    Ondansetron 8-16 mg IV or by mouth (PO) 30 minutes prior to administration of chemotherapy.
    Other Name: Zofran
  • Drug: Dexamethasone
    Dexamethasone 10-20 mg IV or PO 30 minutes prior to drug administration.
    Other Name: Decadron
  • Drug: Granisetron
    Granisetron 10 mcg/kg IV (or 2 mg PO) 30 minutes prior to chemotherapy.
    Other Name: Kytril
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 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).

Ondansetron and dexamethasone - OR - granisetron and dexamethasone will be administered prior to chemotherapy.

Interventions:
  • Drug: Triciribine
  • Drug: Carboplatin
  • Drug: Ondansetron
  • Drug: Dexamethasone
  • Drug: Granisetron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
October 2015
October 2015   (final data collection date for primary outcome measure)

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: AST (SGOT) and ALT (SGPT) ≤ 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
  • Patient tumors must demonstrate high (>median) phospho-BAD levels on immunohistochemical-based analyses.

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
Female
18 Years and older
No
United States
 
NCT01690468
MCC-17035
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
  • Department of Defense
  • Cahaba Pharmaceuticals
Principal Investigator: Patricia L. Judson, M.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
September 2014

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