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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day of surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Incidence of dose limiting toxicities (dose escalation phase)

Incidence of dose limiting toxicities (dose expansion phase)

Other outcome measures

Measurements of tissue and blood pharmacokinetics for ipatasertib

Phosphorylated (p)PRAS40 expression in tumor

Neoplasms

Side effects data

From 2023 Phase 3 trial • 242 Patients • NCT04177108

74%

Diarrhoea

40%

Nausea

35%

Neutropenia

35%

Anaemia

35%

Neuropathy peripheral

26%

Alanine aminotransferase increased

23%

Alopecia

23%

Hyperglycaemia

23%

Rash

21%

Asthenia

19%

Fatigue

16%

Constipation

16%

Aspartate aminotransferase increased

16%

Vomiting

14%

Mucosal inflammation

14%

Pyrexia

14%

Decreased appetite

12%

Paraesthesia

12%

Abdominal pain upper

12%

Neutrophil count decreased

12%

White blood cell count decreased

12%

Myalgia

12%

Blood alkaline phosphatase increased

12%

Blood creatinine increased

Dizziness

Cough

Rhinorrhoea

Urticaria

Leukopenia

Gamma-glutamyltransferase increased

Peripheral sensory neuropathy

Weight decreased

Hypokalaemia

Arthralgia

Insomnia

Epistaxis

Hypomagnesaemia

Lymphocyte count decreased

Stomatitis

Back pain

Dyspepsia

Urinary tract infection

Infusion related reaction

Illness

Pruritus

Hyperbilirubinaemia

Lymphoedema

Abdominal discomfort

Gastrooesophageal reflux disease

Cellulitis

Septic shock

Polyneuropathy

COVID-19

Hyponatraemia

Headache

Abdominal pain

Oedema peripheral

Hypothyroidism

Bone pain

Dyspnoea

Erythema

Blood glucose increased

Lymphopenia

Musculoskeletal pain

Cholecystitis infective

Pyelonephritis

Blood albumin decreased

Gastritis

Glycosylated haemoglobin increased

Hypernatraemia

Dehydration

COVID-19 pneumonia

Hypersensitivity

Upper gastrointestinal haemorrhage

Clostridium difficile colitis

Drug eruption

Lipase increased

Hypocalcaemia

Pleural effusion

Hyperkalaemia

Eczema

Accidental overdose

Acute kidney injury

Blood lactate dehydrogenase increased

Blood cholesterol increased

Rash maculo-papular

Dry mouth

Neurotoxicity

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel

Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel

Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel

Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe

Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel

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

~5380

Biopsy

2014

Completed Phase 4

~1090

Carboplatin

2014

Completed Phase 3

~6670

Ipatasertib

2011

Completed Phase 3

~2320

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,664 Previous Clinical Trials

40,925,981 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,828 Total Patients Enrolled

Katherine C FuhPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Approximately how many individuals have enrolled in this experiment?

"This clinical trial necessitates the participation of 24 suitable individuals. In particular, people can take part in this research from University of Oklahoma Health Sciences Center and NRG Oncology located in Oklahoma City and Philadelphia respectively."

Answered by AI

To what degree does Ipatasertib pose a health risk to individuals?

"Given the limited amount of data surrounding Ipatasertib's safety and efficacy, its score on our risk assessment scale was 1."

Answered by AI

How extensively is this trial being conducted across the state?

"Potential participants in this trial are being enrolled at the University of Oklahoma Health Sciences Center, NRG Oncology and Women and Infants Hospital along with 5 other sites."

Answered by AI

Are new participants currently being enrolled in this clinical trial?

"As attested on clinicaltrials.gov, the trial is currently recruiting participants since it was posted in late June and lastly updated in early November this year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer

2022. "Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05276973.

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