CancerPhase 2CINOVANCT03742713
Efficacy Study of CPC634 (CriPec® Docetaxel) in Platinum Resistant Ovarian Cancer
A Phase 2 study testing CPC634 (CriPec® docetaxel) in people with Cancer and Ovarian Cancer, run by Cristal Therapeutics at 8 sites in 3 countries.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Ovarian Cancer
- What is being tested?
- CPC634 (CriPec® docetaxel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 1 Oct 2018to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 8 years.
- Histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian or peritoneal cancer.
- 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.
- Measurable disease according to RECIST version 1.1. Only CA-125 progression without any clinical or radiological progression is not allowed.
- Performance status (WHO scale/ECOG) 1.
- Estimated life expectancy of at least 5 months.
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- 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).
- ANC ≥ 1.5 x 109/L; platelets ≥100 x 109/L; hemoglobin ≥ 5.58 mmol/L (≥ 9.00 g/dL)
- 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.
- 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.
- Written informed consent according to local guidelines.
Who cannot join
- 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.
- 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.
- Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
- 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).
- 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.
- 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.
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- Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100mm Hg).
- Grade ≥ 2 motor or sensory neuropathy symptoms (as defined by CTCAE version 5.0).
- Known hypersensitivity to any of the study drugs or excipients or taxanes.
- 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.
- 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.
- 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.
- 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).
- Known hypersensitivity to dexamethasone or any other reason that would make the subject not eligible to receive dexamethasone.
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Netherlands5 sites
University Medical Center Groningen
Groningen, 9713 GZ
Dijklander Hospital
Hoorn, 1624NP
Radboud University Medical Center
Nijmegen, 6525 GA
Erasmus University Medical Center Rotterdam
Rotterdam, 3015 GD
Viecuri Medical Center
Venlo, 5912 BL
Belgium2 sites
Universitaire Ziekenhuizen Leuven
Leuven, B3000
CHU de Liège
Liège, B-4000
About this study
Official title: A Phase Ila Exploratory 2-stage Design Study of CPC634 (CriPec® Docetaxel) Monotherapy in Subjects With Platinum Resistant Ovarian Cancer.
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
.
Read the detailed description
This Phase IIa exploratory 2-stage trial assessed the efficacy, safety and tolerability of CPC634 (CriPec® docetaxel) administered IV, Q3W to 25 subjects (13 in Stage 1 and 12 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.
- Conditions
- Cancer, Ovarian Cancer
- Being tested
- CPC634 (CriPec® docetaxel)
- Medical subject headings
- Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC634 (CriPec® docetaxel)Drug
Docetaxel containing CriPec® nanoparticles
| Study group | Role | What they receive |
|---|---|---|
| CPC634 (CriPec® docetaxel) | Experimental | CPC634 (CriPec® docetaxel) administered intra-venously every 21 days at 60 mg/m2 Receives: Drug: CPC634 (CriPec® docetaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
To evaluate the incidence of Treatment-Emergent Adverse Events (safety and tolerability) of CPC634 (CriPec® docetaxel) according to NCI-CTCAE criteria (version 5.0)
Measured: At the end of Cycle 6 (each cycle is 21 days)
Progression free survival
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
Measured: After 6 months
GCIG CA-125 response criteria
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
Measured: At the end of Cycle 6 (each cycle is 21 days)
Duration of response (DOR)
Duration of response (DOR) based on RECIST version 1.1 and combined assessment using GCIG definitions for CA-125
Measured: At the end of Cycle 6 (each cycle is 21 days)
Time to progression (TTP)
Time from treatment assignment to time of progressive disease per RECIST version 1.1.
Measured: After 6 months
Disease control rate (DCR)
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
Measured: At the end of Cycle 6 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristal Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Ledermann, MD,PhD, Principal investigator, UCL Cancer Institute, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742713
- Sponsor's protocol ID
- CT-CL02
- Acronym
- CINOVA
- Status last verified
- Dec 2020
- First submitted
- 8 Nov 2018
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ila Exploratory 2-stage Design Study of CPC634 (CriPec® Docetaxel) Monotherapy in Subjects With Platinum Resistant Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT03742713
- Acronym / sponsor ID
- CINOVA / CT-CL02
- Conditions
- Cancer, Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cristal TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
.
Detailed description
This Phase IIa exploratory 2-stage trial assessed the efficacy, safety and tolerability of CPC634 (CriPec® docetaxel) administered IV, Q3W to 25 subjects (13 in Stage 1 and 12 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPC634 (CriPec® docetaxel) | Experimental | Drug: CPC634 (CriPec® docetaxel)CPC634 (CriPec® docetaxel) administered intra-venously every 21 days at 60 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 8 years.
- Histologically or cytologically confirmed diagnosis of epithelial ovarian, fallopian or peritoneal cancer.
- 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.
- Measurable disease according to RECIST version 1.1. Only CA-125 progression without any clinical or radiological progression is not allowed.
- Performance status (WHO scale/ECOG) 1.
Key exclusion criteria (15 listed)
- 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.
- 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.
- Current or recent (within 28 days of first study treatment) treatment with another investigational drug or participation in another investigational study.
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPC634 (CriPec® docetaxel)Docetaxel containing CriPec® nanoparticles | Drug | CPC634 (CriPec® docetaxel) |
Primary outcome
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.
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Progression free survival
Time frame: After 6 months
GCIG CA-125 response criteria
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Duration of response (DOR)
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Time to progression (TTP)
Time frame: After 6 months
Disease control rate (DCR)
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Ledermann, MD,PhD principal investigator
UCL Cancer Institute, London, UK
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPC634 (CriPec® docetaxel) in people with Cancer and Ovarian Cancer, run by Cristal Therapeutics at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, Belgium, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: At the end of Cycle 6 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2020.