Ovarian NeoplasmsPhase 2NCT04561817
To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer
A Phase 2 study testing Ipatasertib and Paclitaxel in people with Ovarian Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Ipatasertib and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Oct 2023
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
- 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
Show all 37Show fewer
- 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
- Sodium or potassium outside normal reference range for site
- Peripheral neuropathy grade 2 or greater
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption Ipatasertib
- History of hypersensitivity to Ipatasertib, or drugs with a similar chemical structure or class to Ipatasertib
- Clinically significant abnormalities of glucose metabolism as defined by any of the following:
- Diagnosis of type I or type II diabetes mellitus requiring insulin
- A baseline fasting glucose value of ≥ 200 mg/dL (fasting glucose value to be obtained only if non-fasting glucose >200mg/dL)
- Glycosylated hemoglobin (HbA1C) >7.5%
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Other malignancies within the past 3 years, with the exception of adequately resected basal or squamous carcinoma of the skin
- Clinically significant pulmonary symptoms or disease
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase II Study to Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer
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.
Read the detailed description
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.
The primary objective of the study is to determine - the safety and objective response rate of treatment with ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer at week 12 for two cohorts of patients: with PI3K/AKT mutations (altered) and without PI3K/AKT mutations (non-altered)
About 39 patients will participate in the study and the accrual will take place over a course of 30 months Patients will be treated until disease progression and followed for 1 year thereafter.
The two drugs are ipatasertib and paclitaxel.
- Ipatasertib will be given 400mg PO daily: day 1-21 of 28 day cycle
- Paclitaxel will be given 80mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle
The study hypothesis is that the combination of Ipatasertib (GDC-0068) plus paclitaxel will safely induce a tumor response and increase the objective response rate in patients with platinum-resistant recurrent epithelial ovarian cancer, with or without PI3K/AKT mutations.
This trial will enroll patients with platinum-resistant recurrent epithelial ovarian cancer. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates. The benefit-risk ratio for ipatasertib in combination with paclitaxel is expected to be acceptable in this setting.
- Conditions
- Ovarian Neoplasms
- Being tested
- Ipatasertib, Paclitaxel
- Keywords
- Platinum-resistant, Ovarian cancer, Ipatasertib, Paclitaxel, Recurrent
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpatasertibDrug
Also called GDC-0068
400mg PO daily: day 1-21 of 28 day cycle
PaclitaxelDrug
80 mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| PI3K/AKT mutations (altered) | Active comparator | Participants with recurrent epithelial ovarian cancer with PI3K/AKT mutations (altered) Receives: Drug: Ipatasertib; Drug: Paclitaxel |
| Without PI3K/AKT mutations (non-altered) | Active comparator | Participants with recurrent epithelial ovarian cancer without PI3K/AKT mutations (non-altered) Receives: Drug: Ipatasertib; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR)
ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response.
Measured: At the end of Cycle 2 (each cycle is 28 days)
Objective response rate (ORR)
ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response.
Measured: At the end of Cycle 3 (each cycle is 28 days)
Secondary outcomes (4)
Progression free survival (PFS)
Disease status will be assessed with comprehensive radiographic studies every 3 treatment cycles (12 weeks +/- 1 week), but the development of new signs or symptoms of disease in between scheduled evaluations may prompt off-schedule radiographic or non-radiographic evaluations. Disease status will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.
Measured: At the end of Cycle 1 (each cycle is 28 days)
Progression free survival (PFS)
Disease status will be assessed with comprehensive radiographic studies every 3 treatment cycles (12 weeks +/- 1 week), but the development of new signs or symptoms of disease in between scheduled evaluations may prompt off-schedule radiographic or non-radiographic evaluations. Disease status will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.
Measured: At the end of Cycle 2 (each cycle is 28 days)
Progression free survival (PFS)
Disease status will be assessed with comprehensive radiographic studies every 3 treatment cycles (12 weeks +/- 1 week), but the development of new signs or symptoms of disease in between scheduled evaluations may prompt off-schedule radiographic or non-radiographic evaluations. Disease status will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.
Measured: At the end of Cycle 3 (each cycle is 28 days)
Disease control rate (DCR)
DCR will be measured by the percentage of patients whose cancer decreases in size or remains stable over the duration of the study. This will be measured as the sum of complete response, partial response, and stable disease for greater than or equal to 24 weeks.
Measured: average 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Why it stopped: Evolving data with Ipatasertib that changes the known risk / benefit background in pursuing future studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- For non-altered patients- An interim analysis is scheduled when the number of enrolled patients reaches 14. The research team will stop the trial for futility if 2 or less than 2 patients respond. When the total number of patients reaches the maximum sample size of 25, the research team will reject the null hypothesis and conclude that the treatment is promising if the number of responses are greater than 6; otherwise the research team will conclude that the treatment is not promising. For altered patients-An interim analysis is scheduled when the number of enrolled patients reaches 8. The research team will stop the entire trial of two cohorts for futility if 1 or less than 1 patients respond. When the total number of patients reaches the maximum sample size of 14, the research team will reject the null hypothesis and conclude that the treatment is promising
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Tiersten, Icahn School of Medicine at Mount Sinai
- Investigators
- Amy Tiersten, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561817
- Sponsor's protocol ID
- GCO 19-2707
- Status last verified
- Oct 2020
- First submitted
- 8 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase II Study to Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04561817
- Acronym / sponsor ID
- GCO 19-2707
- Conditions
- Ovarian Neoplasms
- Keywords
- Platinum-resistant, Ovarian cancer, Ipatasertib, Paclitaxel, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Evolving data with Ipatasertib that changes the known risk / benefit background in pursuing future studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 24 Sep 2020 (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.
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.
Detailed description
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.
The primary objective of the study is to determine - the safety and objective response rate of treatment with ipatasertib (GDC-0068) in combination with paclitaxel in platinum-resistant recurrent epithelial ovarian cancer at week 12 for two cohorts of patients: with PI3K/AKT mutations (altered) and without PI3K/AKT mutations (non-altered)
About 39 patients will participate in the study and the accrual will take place over a course of 30 months Patients will be treated until disease progression and followed for 1 year thereafter.
The two drugs are ipatasertib and paclitaxel.
- Ipatasertib will be given 400mg PO daily: day 1-21 of 28 day cycle
- Paclitaxel will be given 80mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle
The study hypothesis is that the combination of Ipatasertib (GDC-0068) plus paclitaxel will safely induce a tumor response and increase the objective response rate in patients with platinum-resistant recurrent epithelial ovarian cancer, with or without PI3K/AKT mutations.
This trial will enroll patients with platinum-resistant recurrent epithelial ovarian cancer. Given the relatively poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates. The benefit-risk ratio for ipatasertib in combination with paclitaxel is expected to be acceptable in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For non-altered patients- An interim analysis is scheduled when the number of enrolled patients reaches 14. The research team will stop the trial for futility if 2 or less than 2 patients respond. When the total number of patients reaches the maximum sample size of 25, the research team will reject the null hypothesis and conclude that the treatment is promising if the number of responses are greater than 6; otherwise the research team will conclude that the treatment is not promising. For altered patients-An interim analysis is scheduled when the number of enrolled patients reaches 8. The research team will stop the entire trial of two cohorts for futility if 1 or less than 1 patients respond. When the total number of patients reaches the maximum sample size of 14, the research team will reject the null hypothesis and conclude that the treatment is promising
| Arm | Type | Receives |
|---|---|---|
| PI3K/AKT mutations (altered) | Active comparator | Drug: Ipatasertib, Drug: PaclitaxelParticipants with recurrent epithelial ovarian cancer with PI3K/AKT mutations (altered) |
| Without PI3K/AKT mutations (non-altered) | Active comparator | Drug: Ipatasertib, Drug: PaclitaxelParticipants with recurrent epithelial ovarian cancer without PI3K/AKT mutations (non-altered) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (37 listed)
- Treatment with any of the following:
- 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
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 |
|---|---|---|
| IpatasertibAlso: GDC-0068400mg PO daily: day 1-21 of 28 day cycle | Drug | PI3K/AKT mutations (altered), Without PI3K/AKT mutations (non-altered) |
| Paclitaxel80 mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle | Drug | PI3K/AKT mutations (altered), Without PI3K/AKT mutations (non-altered) |
Primary outcome
Objective response rate (ORR)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response.
Objective response rate (ORR)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response.
Objective response rate (ORR)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response.
4 secondary outcomes
Progression free survival (PFS)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Progression free survival (PFS)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Progression free survival (PFS)
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Disease control rate (DCR)
Time frame: average 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Amy Tiersten, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipatasertib and Paclitaxel in people with Ovarian Neoplasms, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 17 inclusion and 37 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: withdrawn, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. 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 6 Oct 2020.