Clinical trial NCT04516447: A Study of ZN-c3 in Patients With Ovarian Cancer
Official title: A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: Solid Tumor
Lead sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of ZN-c3 in combination with other drugs.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: To investigate the safety and tolerability of ZN-c3 in combination with PLD, carboplatin, paclitaxel, gemcitabine, or bevacizumab
timeFrame: Through completion, approximately 40 months
measure: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of ZN-c3 in combination with PLD, carboplatin, paclitaxel, or gemcitabine
timeFrame: Through Cycle 1 (cycle is 28 days for PLD or paclitaxel, and 21 days for carboplatin, gemcitabine, or bevacizumab)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Site 0264
state: Colorado
city: Boston
country: United States
facility: Site 0104
state: Massachusetts
city: Saint Louis
country: United States
facility: Site 0111
state: Missouri
city: New York
country: United States
facility: Site 0173
state: New York
city: Durham
country: United States
facility: Site 0259
state: North Carolina
city: Providence
country: United States
facility: Site 0191
state: Rhode Island
city: Nashville
country: United States
facility: Site 0196
state: Tennessee
city: Houston
country: United States
facility: Site 0103
state: Texas
city: South Brisbane
country: Australia
facility: Site 2707
state: Queensland
city: Sunshine Coast
country: Australia
facility: Site 2708
state: Queensland
city: Adelaide
country: Australia
facility: Site 2709
state: South Australia
city: Melbourne
country: Australia
facility: Site 2716
state: Victoria
city: Melbourne
country: Australia
facility: Site 2706
state: Victoria
city: Nedlands
country: Australia
facility: Site 2705
state: Western Australia
city: Banja Luka
country: Bosnia and Herzegovina
facility: Site 1001
city: Sarajevo
country: Bosnia and Herzegovina
facility: Site 1002
city: Tuzla
country: Bosnia and Herzegovina
facility: Site 1003
city: Panagyurishte
country: Bulgaria
facility: Site 1202
city: Sofia
country: Bulgaria
facility: Site 1201
city: Tbilisi
country: Georgia
facility: Site 1401
city: Busan
country: Korea, Republic of
facility: Site 2901
city: Seoul
country: Korea, Republic of
facility: Site 2903
city: Seoul
country: Korea, Republic of
facility: Site 2904
city: Belgrade
country: Serbia
facility: Site 1902
Study officials:
References: