To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Ovarian Neoplasms

In brief

This is a phase II open label, non-randomized, study to evaluate the safety and efficacy of Ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer.

Key facts

Study ID: NCT04561817
Run by: Icahn School of Medicine at Mount Sinai
People needed: 0
Starts: 2020-10-01
Expected to finish: 2023-10-01
Last updated by the study team: 2020-10-06

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
o If a patient declines to participate in any voluntary exploratory research and/or genetic component of the study, there will be no penalty or loss of benefit to the patient and he/she will not be excluded from other aspects of the study
Aged at least 18 years at time of signing informed consent
A pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer, including fallopian or primary peritoneal cancer
o low grade serous histology is excluded
Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) that has become "platinum-resistant," defined as progression of disease within 6 months from the last dose of platinum-based chemotherapy, or platinum refractory
Not a candidate for cytoreductive surgery
Measurable disease (at least one lesion that can be accurately assessed repeatedly by CT or MRI) as evidenced on pre-treatment baseline CT of Chest/Abdomen/Pelvis, MRI, or PET/CT, or evaluable disease (defined as anything non-measurable- pleural effusions, lesions <1cm, etc).
World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
Up to 3 lines of prior cytotoxic chemotherapy
Previously received bevacizumab
Has not received weekly paclitaxel-containing regimen, EXCEPT for in the front-line setting
o Patients with prior paclitaxel reactions may be enrolled if they have been successfully re-treated with steroid pre-medication in the past
Patients must use adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing (within 7 days) if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
Post-menopausal defined as aged more than 50 years and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 28 days after the last dose of study treatment. Women must refrain from donating eggs during this same period.

You may not qualify if…

Treatment with any of the following:
Any investigational agents or study drugs from a previous clinical study within 28 days of the first dose of study treatment
Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment
Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
Any prior exposure to Ipatasertib
Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment
With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 2 weeks prior to start of study treatment
Concurrent use of endocrine therapy
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Any of the following cardiac criteria:
Any clinically important abnormalities in rhythm, known prolonged QTc, conduction or morphology of resting ECG, complete left bundle branch block, third degree heart block
Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade 2 or greater
Uncontrolled hypotension - Systolic BP <90mmHg and/or diastolic BP <50mmHg
Left ventricular ejection fraction (LVEF) below lower limit of normal for site
Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
Absolute neutrophil count < 1.5 x 109/L
Platelet count < 100 x 109/L
Hemoglobin < 9 g/L
Alanine aminotransferase > 2.5 times the upper limit of normal (ULN)
Aspartate aminotransferase > 2.5 times ULN
Total bilirubin > 1.5 times ULN
Creatinine >1.5 times ULN concurrent with creatinine clearance < 50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5 times ULN
Proteinuria 3+ on dipstick analysis or >500mg/24 hours

Where it is running

Dubin Breast Center — New York, New York, United States

Full record on ClinicalTrials.gov

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