Efficacy Study of CPC634 (CriPec® Docetaxel) in Platinum Resistant Ovarian Cancer
NCT ID: NCT03742713
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2018-10-01
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CPC634 (CriPec® docetaxel)
CPC634 (CriPec® docetaxel) administered intra-venously every 21 days at 60 mg/m2
CPC634 (CriPec® docetaxel)
Docetaxel containing CriPec® nanoparticles
Interventions
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CPC634 (CriPec® docetaxel)
Docetaxel containing CriPec® nanoparticles
Eligibility Criteria
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Inclusion Criteria
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). Subjects who have received a maximum of 2 prior treatment lines of which one could have been taxane- based.
4. Measurable disease according to RECIST version 1.1. Only CA-125 progression without any clinical or radiological progression is not allowed.
5. Performance status (WHO scale/ECOG) 1.
6. Estimated life expectancy of at least 5 months.
7. 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).
8. ANC ≥ 1.5 x 109/L; platelets ≥100 x 109/L; hemoglobin ≥ 5.58 mmol/L (≥ 9.00 g/dL)
9. 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.
10. 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.
11. Written informed consent according to local guidelines.
Exclusion Criteria
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.
18 Years
FEMALE
No
Sponsors
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Cristal Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jonathan Ledermann, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
UCL Cancer Institute, London, UK
Locations
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Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
University Medical Center Groningen
Groningen, , Netherlands
Dijklander Hospital
Hoorn, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, , Netherlands
Viecuri Medical Center
Venlo, , Netherlands
UCL Cancer Institute
London, , United Kingdom
Countries
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Other Identifiers
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CT-CL02
Identifier Type: -
Identifier Source: org_study_id