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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)

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

Rash maculo-papular

Hypokalaemia

Pruritus

Constipation

Nasopharyngitis

Cough

Urinary tract infection

Pain in extremity

Upper respiratory tract infection

Bone pain

Dizziness

Blood creatinine increased

Dyspepsia

Hypertriglyceridaemia

Abdominal pain

Pyrexia

Fall

Haematuria

Dyspnoea

Hot flush

Musculoskeletal pain

Insomnia

Pneumonia

Dehydration

Erythema multiforme

Cardiac failure

Cellulitis

Sepsis

Acute kidney injury

Nephrolithiasis

Acute myocardial infarction

Myocardial infarction

Death

Pulmonary embolism

Septic shock

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Abiraterone

Ipatasertib + Abiraterone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5450

Biopsy

2014

Completed Phase 4

~1090