PTX-200 and Carboplatin in Ovarian Cancer
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Purpose
| 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 |
- 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).
- 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:
Drug: Carboplatin
Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01690468
| Contact: Mandeep Grewal | mandeep@ptxtherapeutics.com |
| 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. | |
| 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: | September 7, 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 September 27, 2016