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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RECRUITING
PHASE1
140 participants
INTERVENTIONAL
2020-10-26
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination with carboplatin
combined with azenosertib
ZN-c3
Investigational drug
Carboplatin
Carboplatin is an approved drug
Combination with PLD
combined with azenosertib
ZN-c3
Investigational drug
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin (PLD) is an approved drug
Combination with paclitaxel
combined with azenosertib
ZN-c3
Investigational drug
Paclitaxel
Paclitaxel is an approved drug
Combination with gemcitabine
combined with azenosertib
ZN-c3
Investigational drug
Gemcitabine
Gemcitabine is an approved drug
Combination with bevacizumab
combined with azenosertib
ZN-c3
Investigational drug
Bevacizumab
Combined with azenosertib
Interventions
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ZN-c3
Investigational drug
Carboplatin
Carboplatin is an approved drug
Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin (PLD) is an approved drug
Paclitaxel
Paclitaxel is an approved drug
Gemcitabine
Gemcitabine is an approved drug
Bevacizumab
Combined with azenosertib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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Site 0264
Aurora, Colorado, United States
Site 0104
Boston, Massachusetts, United States
Site 0111
St Louis, Missouri, United States
Site 0173
New York, New York, United States
Site 0259
Durham, North Carolina, United States
Site 0191
Providence, Rhode Island, United States
Site 0196
Nashville, Tennessee, United States
Site 0103
Houston, Texas, United States
Site 2707
South Brisbane, Queensland, Australia
Site 2708
Sunshine Coast, Queensland, Australia
Site 2709
Adelaide, South Australia, Australia
Site 2716
Melbourne, Victoria, Australia
Site 2706
Melbourne, Victoria, Australia
Site 2705
Nedlands, Western Australia, Australia
Site 1001
Banja Luka, , Bosnia and Herzegovina
Site 1002
Sarajevo, , Bosnia and Herzegovina
Site 1003
Tuzla, , Bosnia and Herzegovina
Site 1202
Panagyurishte, , Bulgaria
Site 1201
Sofia, , Bulgaria
Site 1401
Tbilisi, , Georgia
Site 1902
Belgrade, , Serbia
Site 2901
Busan, , South Korea
Site 2903
Seoul, , South Korea
Site 2904
Seoul, , South Korea
Countries
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Central Contacts
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K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals
Role: CONTACT
Other Identifiers
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ZN-c3-002
Identifier Type: -
Identifier Source: org_study_id
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