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Efficacy Study of CPC634 (CriPec® Docetaxel) in Platinum Resistant Ovarian Cancer (CINOVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742713
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Cristal Therapeutics

Study Description
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Brief Summary:

The purpose of this study is to determine whether CPC634 (CriPec® docetaxel) is effective in the treatment of patients with advanced epithelial ovarian cancer who are resistant to prior platinum-based chemotherapy

.


Condition or disease Intervention/treatment Phase
Cancer Ovarian Cancer Drug: CPC634 (CriPec® docetaxel) Phase 2

Detailed Description:
This Phase IIa exploratory 2-stage trial will assess the efficacy, safety and tolerability of CPC634 (CriPec® docetaxel) administered IV, Q3W to 27 subjects (13 in Stage 1 and 14 in Stage 2) with ovarian cancer that is resistant to prior platinum-based therapy. Subjects will be treated continuously every 21 days at 60 mg/m2, which is the RP2D of CPC634 (CriPec® docetaxel) that was determined in the Phase I CT-CL01, until disease progression, unacceptable toxicity, or discontinuation for any other reason.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ila Exploratory 2-stage Design Study of CPC634 (CriPec® Docetaxel) Monotherapy in Subjects With Platinum Resistant Ovarian Cancer.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: CPC634 (CriPec® docetaxel)
CPC634 (CriPec® docetaxel) administered intra-venously every 21 days at 60 mg/m2
 Drug: CPC634 (CriPec® docetaxel)
Docetaxel containing CriPec® nanoparticles


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    To determine the Objective Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 of CPC634 (CriPec® docetaxel) monotherapy in subjects with ovarian cancer who are resistant to prior platinum-based therapy.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (safety and tolerability) [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    To evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability) of CPC634 (CriPec® docetaxel) according to NCI-CTCAE criteria (version 5.0)

  2. Progression free survival [ Time Frame: After 6 months ]
    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

  3. GCIG CA-125 response criteria [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    GCIG CA-125 response criteria defined as at least a 50% reduction in CA-125 levels from a pretreatment sample confirmed and maintained for at least 28 days

  4. Duration of response (DOR) [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    Duration of response (DOR) based on RECIST version 1.1 and combined assessment using GCIG definitions for CA-125

  5. Time to progression (TTP) [ Time Frame: After 6 months ]
    Time from treatment assignment to time of progressive disease per RECIST version 1.1.

  6. Disease control rate (DCR) [ Time Frame: At the end of Cycle 6 (each cycle is 21 days) ]
    Disease control rate (DCR) will be determined based on the percentage of subjects who have achieved complete response (CR), partial response (PR) and stable disease (SD) with treatment of CriPec® docetaxel


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 8 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). 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:

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742713


Contacts
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Contact: Rob Hanssen, PhD +31 43 3885868 rob.hanssen@cristaltherapeutics.com
Contact: Axel Mescheder, MD,PhD +31 43 3885868 axel.mescheder@cristaltherapeutics.com

Locations
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Belgium
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Belgium, B3000
Contact: Ignace Vergote, MD,PhD    +32 16 34 51 28    ignace.vergote@uzleuven.be   
CHU de Liège Recruiting
Liège, Belgium, B-4000
Contact: Christine Gennigens, Dr.    +32 43 66 8250    christine.gennigens@chu.ulg.ac.be   
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: M. Jalving, Dr.    +31 50 361 6161    m.jalving@umcg.nl   
Dijklander Hospital Recruiting
Hoorn, Netherlands, 1624NP
Contact: S M van den Heiligenberg, Dr.    +31 229257823    S.M.vandenHeiligenberg@westfriesgasthuis.nl   
Radboud University Medical Center Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Nelleke Ottevanger, Dr.    +31 24 361 3457    nelleke.ottevanger@radboudumc.nl   
Erasmus University Medical Center Rotterdam Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: I. Boere, Dr.    +31 10 703 4897    i.boere@erasmusmc.nl   
Viecuri Medical Center Recruiting
Venlo, Netherlands, 5912 BL
Contact: A. v.d. Wouw, Dr.    +31 77 320 5555    yvdwouw@viecuri.nl   
United Kingdom
UCL Cancer Institute Recruiting
London, United Kingdom, W1T 4TJ
Contact: Jonathan Ledermann, MD,PhD    +44 2076799898    j.ledermann@ucl.ac.uk   
Sponsors and Collaborators
Cristal Therapeutics
Investigators
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Principal Investigator: Jonathan Ledermann, MD,PhD UCL Cancer Institute, London, UK
More Information
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Responsible Party: Cristal Therapeutics
ClinicalTrials.gov Identifier: NCT03742713    
Other Study ID Numbers: CT-CL02
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
 Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action