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Platinum-containing compound

Ipatasertib + Chemotherapy for Ovarian Cancer

Phase 1
Recruiting
Led By Katherine C Fuh
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Disease considered unresectable via primary debulking surgery and in need of neoadjuvant chemotherapy (NACT) prior to debulking surgery
Histologic cell types eligible: High grade serous, Endometrioid adenocarcinoma, grade 3
Must not have
Active infections requiring intravenous antibiotics
Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day of surgery
Awards & highlights

Summary

This trial is testing the safety and efficacy of combining ipatasertib with paclitaxel and carboplatin to treat ovarian cancer. Ipatasertib works by blocking some of the enzymes needed for cell growth, while paclitaxel and carboplatin work by killing or slowing the growth of tumor cells. The combination of these drugs may be more effective in treating ovarian cancer than paclitaxel and carboplatin alone.

Who is the study for?
This trial is for women aged 18+ with stage III or IV epithelial ovarian cancer that's inoperable and hasn't been treated yet. Participants must have good performance status, meet specific blood count and organ function criteria, not be pregnant or breastfeeding, agree to use two forms of birth control, and can't have had prior treatments targeting the PI3K/AKT/mTor pathway.
What is being tested?
The study tests the safety and optimal dose of ipatasertib combined with standard chemotherapy drugs paclitaxel and carboplatin. Ipatasertib may block enzymes needed for tumor growth while the chemo drugs aim to stop or slow down tumor cell division, potentially improving treatment outcomes.
What are the potential side effects?
Possible side effects include reactions related to blocking enzymes necessary for cell growth (ipatasertib), issues from stopping tumor cells' growth/division (paclitaxel), as well as those associated with platinum-containing compounds like carboplatin which might include nerve damage, allergic reactions, bone marrow suppression leading to low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition requires chemotherapy before surgery to remove my tumor.
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My cancer is high grade serous or grade 3 endometrioid adenocarcinoma.
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My cancer is at stage III or IV.
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I have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer.
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I am 18 years old or older.
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I have not received any treatment for ovarian cancer before.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on IV antibiotics for an infection.
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I haven't taken strong CYP3A affecting drugs recently.
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I have had radiation therapy to my abdomen or pelvis before.
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My diabetes or cholesterol levels are not well-managed.
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I have a serious liver condition.
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I have cancer that has spread to my brain or its coverings.
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I am allergic to medications similar to ipatasertib, paclitaxel, or carboplatin.
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I have or had inflammatory bowel disease or active bowel inflammation.
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I have been treated with drugs targeting the PI3K/AKT/mTor pathway.
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I do not have any unmanaged ongoing illnesses.
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I have a lung disease or infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Incidence of dose limiting toxicities (dose escalation phase)
Other study objectives
Measurements of tissue and blood pharmacokinetics for ipatasertib
Phosphorylated (p)PRAS40 expression in tumor
Neoplasms

Side effects data

From 2024 Phase 3 trial • 1101 Patients • NCT03072238
79%
Diarrhoea
38%
Hyperglycaemia
28%
Nausea
26%
Rash
22%
Fatigue
20%
Alanine aminotransferase increased
19%
Anaemia
18%
Decreased appetite
18%
Asthenia
17%
Vomiting
17%
Aspartate aminotransferase increased
15%
Back pain
14%
Hypertension
13%
Oedema peripheral
12%
Weight decreased
12%
Arthralgia
10%
Headache
9%
Rash maculo-papular
8%
Hypokalaemia
8%
Pruritus
8%
Constipation
8%
Nasopharyngitis
8%
Cough
7%
Urinary tract infection
7%
Pain in extremity
7%
Upper respiratory tract infection
7%
Bone pain
7%
Dizziness
6%
Blood creatinine increased
6%
Dyspepsia
6%
Hypertriglyceridaemia
6%
Abdominal pain
6%
Pyrexia
6%
Fall
6%
Haematuria
6%
Dyspnoea
5%
Hot flush
5%
Musculoskeletal pain
4%
Insomnia
2%
Pneumonia
2%
Dehydration
1%
Erythema multiforme
1%
Cardiac failure
1%
Cellulitis
1%
Sepsis
1%
Acute kidney injury
1%
Nephrolithiasis
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Death
1%
Pulmonary embolism
1%
Septic shock
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Abiraterone
Ipatasertib + Abiraterone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel, carboplatin, ipatasertib)Experimental Treatment4 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive ipatasertib PO QD until 24 hours before surgery in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5810
Biopsy
2014
Completed Phase 4
~1090
Carboplatin
2014
Completed Phase 3
~6120
Ipatasertib
2017
Completed Phase 3
~3490

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,976 Total Patients Enrolled
NRG OncologyOTHER
236 Previous Clinical Trials
102,251 Total Patients Enrolled
Katherine C FuhPrincipal InvestigatorNRG Oncology
~3 spots leftby Jan 2025
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