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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04516447




Registration number
NCT04516447
Ethics application status
Date submitted
11/08/2020
Date registered
18/08/2020

Titles & IDs
Public title
A Study of ZN-c3 in Patients With Ovarian Cancer
Scientific title
A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
Secondary ID [1] 0 0
ZN-c3-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Epithelial Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZN-c3
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pegylated liposomal doxorubicin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Other - Bevacizumab

Experimental: Combination with carboplatin - combined with azenosertib

Experimental: Combination with PLD - combined with azenosertib

Experimental: Combination with paclitaxel - combined with azenosertib

Experimental: Combination with gemcitabine - combined with azenosertib

Experimental: Combination with bevacizumab - combined with azenosertib


Treatment: Drugs: ZN-c3
Investigational drug

Treatment: Drugs: Carboplatin
Carboplatin is an approved drug

Treatment: Drugs: Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin (PLD) is an approved drug

Treatment: Drugs: Paclitaxel
Paclitaxel is an approved drug

Treatment: Drugs: Gemcitabine
Gemcitabine is an approved drug

Treatment: Other: Bevacizumab
Combined with azenosertib
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab
Timepoint [1] 0 0
Through completion, approximately 40 months
Primary outcome [2] 0 0
To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
Timepoint [2] 0 0
Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma.
* Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting.
* Measurable disease per RECIST version 1.1.
* Adequate hematologic and organ function as defined by the following criteria:

1. ANC = 1.5 × 10^9/L; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim.
2. Platelet count = 100 × 10^9/L; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors.
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 × upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastases, AST and ALT = 5 x ULN.
4. Total serum bilirubin = 1.5 × ULN or = 3 × ULN in the case of Gilbert's disease.
5. Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 60 mL/min.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
* Any of the following treatment interventions within the specified time frame prior to Cycle 1 Day 1:

1. Major surgery within 28 days.
2. Radiation therapy within 21 days.
3. Autologous or allogeneic stem cell transplant within 3 months.

A serious illness or medical condition(s) including, but not limited to, the following:

1. Brain metastases that require immediate treatment or are clinically or radiographically unstable.
2. Myocardial impairment of any cause.
3. Significant gastrointestinal abnormalities.
4. Active or uncontrolled infection.
5. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months prior to Cycle 1 Day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to Cycle 1 Day 1.

* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2027
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Site 2707 - South Brisbane
Recruitment hospital [2] 0 0
Site 2708 - Sunshine Coast
Recruitment hospital [3] 0 0
Site 2709 - Adelaide
Recruitment hospital [4] 0 0
Site 2706 - Melbourne
Recruitment hospital [5] 0 0
Site 2705 - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4556 - Sunshine Coast
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3144 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Rhode Island
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Banja Luka
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Sarajevo
Country [11] 0 0
Bosnia and Herzegovina
State/province [11] 0 0
Tuzla
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Panagyurishte
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Sofia
Country [14] 0 0
Georgia
State/province [14] 0 0
Tbilisi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Busan
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Serbia
State/province [17] 0 0
Belgrade

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
8582634333
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04516447