Platinum Resistant Ovarian Cancer. MedDRA version: 20.0 Level: PT Classification code 10061328 Term: Ovarian epithelial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: CriPec® docetaxel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type
Sponsors
Cristal Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian or peritoneal cancer. 3. Platinum-resistant recurrent epithelial ovarian cancer (defined as progression within 6 months after last platinum dose). 4. Subjects who have received a maximum of two prior treatment lines, of which one could have been taxane based. 5. Measurable disease according to RECIST version 1.1. Only CA-125 progression without any clinical or radiological progression is not allowed. 6. Performance status (WHO scale/ECOG) = 1 (Appendix 1). 7. Estimated life expectancy of at least 5 months. 8. Toxicities incurred as a result of previous anti-cancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to = Grade 2 (as defined by NCI- CTCAE version 5.0). 9. ANC = 1.5 x 109/L; platelets = 100 x 109/L; hemoglobin = 5.58 mmol/L (= 9.00 g/dL). 10. Creatinine = 1.75 x Upper Limit of Normal (ULN) and estimated creatinine clearance = 30 mL/min according to Cockcroft-Gault formula; Serum albumin levels > 25g/L 11. Serum bilirubin = 1.5 x ULN except for subjects with Will Gilbert’s syndrome, alkaline phosphatase, ASAT and ALAT = 2.5 x ULN, unless related to liver metastases, in which case = 5 x ULN is allowed. 12. Written informed consent according to local guidelines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Subjects with platinum-refractory disease. Refractory disease is defined by subjects who progressed during the preceding treatment or within 4 weeks after last dose of platinum containing therapy. 2. Less than four weeks since the last treatment with other anti-cancer therapies, (i.e. endocrine therapy, immunotherapy, radiotherapy, chemotherapy, etc.); less than eight weeks for cranial radiotherapy, and less than six weeks for nitrosoureas and mitomycin C prior to first study treatment. 3. Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study. 4. Active or symptomatic brain metastases. Subjects must be on a stable or decreasing dose of corticosteroids and/or have no requirement for anticonvulsants for five days prior to Cycle 1 day1 (C1D1). 5. Current malignancies other than epithelial ovarian, fallopian or peritoneal cancer, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. 6. Major surgical procedure (including open biopsy, excluding central line IV and portacath) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment. 7. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100mm Hg). 8. Grade = 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5.0). 9. Known hypersensitivity to any of the study drugs or excipients or taxanes. 10. Any skin toxicity in the medical history of the subject of Grade = 2 associated with impaired skin integrity (skin toxicity defined as any form of rash, HFS, skin ulceration, toxic epidermal necrolysis, eczema) or any skin toxicity for which systemic treatment was needed. 11. Clinically significant (i.e. active) cardiovascular disease defined as stroke, transient ischemic attack (TIA) or myocardial infarction within = 6 months prior to first trial treatment. 12. Subjects, who are pregnant or breastfeeding. Serum pregnancy test to be performed within 7 days prior to study treatment start in subjects of childbearing potential. 13. Absence of highly effective method of contraception as of C1D1 in female subjects of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile). 14. Known hypersensitivity to dexamethasone or any other reason that would make the subject not eligible to receive dexamethasone. 15. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, drug or alcohol abuse, physical examination or laboratory findings) that may interfere with the planned treatment, affect subject compliance or place the subject at high risk from treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To determine the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of CriPec® docetaxel monotherapy in subjects with ovarian cancer who are resistant to prior platinum-based therapy.;Main Objective: To determine the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of CriPec® docetaxel monotherapy in subjects with ovarian cancer who are resistant to prior platinum-based therapy.;Secondary Objective: • To evaluate the safety and tolerability of CriPec® docetaxel according to NCI-CTCAE criteria (version 5.0) • To evaluate the clinical activity of CriPec® docetaxel as measured by: o Progression free survival (PFS) at 6 months based on RECIST version 1.1 and combined assessment using Gynecological Cancer Intergroup (GCIG) definitions for CA-125 o GCIG CA-125 response criteria o Duration of response (DOR) based on RECIST version 1.1 and combined assessment using GCIG definitions for CA-125 o Time to progression (TTP) o Disease control rate (DCR) ;Timepoint(s) of evaluation of this end point: At least twice throughout the trial, the Data Review Committee (DRC) will review tables, listings and figures, specifically capturing the data on safety and efficacy variables. The data for efficacy and safety will also be reviewed on a continuous basis. One review was held after subject 13 of Stage 1 had EOT response assessment. The DRC recommended continuation of the study to the second part. During the second part at least one DRC review is planned. The DRC will make a recommendation on the continuation of the enrollment in the second part of the trial, up to 14 additional subjects for a total of 27 subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At least twice throughout the trial, the Data Review Committee (DRC) will review tables, listings and figures, specifically capturing the data on safety and efficacy variables. The data for efficacy and safety will also be reviewed on a continuous basis. One review was held after subject 13 of Stage 1 had EOT response assessment. The DRC recommended continuation of the study to the second part. During the second part at least one DRC review is planned. The DRC will make a recommendation on the continuation of the enrollment in the second part of the trial, up to 14 additional subjects for a total of 27 subjects.;Secondary end point(s): • To evaluate the safety and tolerability of CriPec® docetaxel according to NCI-CTCAE criteria (version 5.0) • To evaluate the clinical activity of CriPec® docetaxel as measured by: o Progression free survival (PFS) at 6 months based on RECIST version 1.1 and combined assessment using Gynecological Cancer Intergroup (GCIG) definitions for CA-125 o GCIG CA-125 response criteria o Duration of response (DOR) based on RECIST version 1.1 and combined assessment using GCIG definitions for CA-125 o Time to progression (TTP) o Disease control rate (DCR) | — |
Countries
Belgium, Netherlands, United Kingdom
Contacts
Public ContactPavlina Topalova
SMS-oncology
Outcome results
None listed