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.
Eligible Conditions
- Stage IVA Primary Peritoneal Cancer
- Stage IIIB Ovarian Cancer
- Stage IIIB Primary Peritoneal Cancer
- Stage IVA Fallopian Tube Cancer
- Stage IVB Fallopian Tube Cancer
- Stage IIIA2 Fallopian Tube Cancer
- Stage IIIB Fallopian Tube Cancer
- Stage III Ovarian Cancer
- Stage IIIA Ovarian Cancer
- Stage IIIC Primary Peritoneal Cancer
- Stage IIIA Primary Peritoneal Cancer
- Stage IIIA1 Fallopian Tube Cancer
- Stage IIIA Fallopian Tube Cancer
- Stage IIIA2 Ovarian Cancer
- Stage IIIA1 Ovarian Cancer
- Stage IVA Ovarian Cancer
- Stage IIIC Fallopian Tube Cancer
- Stage IVB Ovarian Cancer
- Stage IVB Primary Peritoneal Cancer
- Fallopian Tube Endometrioid Adenocarcinoma
- High Grade Serous Ovarian Cancer
- Stage III Primary Peritoneal Cancer
- Stage IV Fallopian Tube Cancer
- Unresectable High Grade Serous Ovarian Cancer
- Unresectable Primary Peritoneal Endometrioid Adenocarcinoma
- Primary Peritoneal Endometrioid Adenocarcinoma
- Stage IV Ovarian Cancer
- Unresectable Fallopian Tube Endometrioid Adenocarcinoma
- Unresectable Primary Peritoneal High Grade Serous Adenocarcinoma
- Unresectable Fallopian Tube High Grade Serous Adenocarcinoma
- Stage IV Primary Peritoneal Cancer
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Cancer
- Primary Peritoneal High Grade Serous Adenocarcinoma
- Stage III Fallopian Tube Cancer
- Unresectable Ovarian Endometrioid Adenocarcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: Within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
Up to 90 days
Phosphorylated (p)PRAS40 expression in tumor
Neoplasms
Day 90
Incidence of adverse events
Up to day of surgery
Measurements of tissue and blood pharmacokinetics for ipatasertib
Day 21
Incidence of dose limiting toxicities (dose escalation phase)
Incidence of dose limiting toxicities (dose expansion phase)
Trial Safety
Safety Progress
Side Effects for
Ipatasertib and Paclitaxel
92%Diarrhoea
54%Alopecia
52%Nausea
30%Fatigue
28%Rash
28%Myalgia
28%Asthenia
28%Vomiting
26%Peripheral Sensory Neuropathy
21%Insomnia
21%Neutropenia
20%Arthralgia
20%Neuropathy Peripheral
20%Constipation
20%Decreased appetite
18%Headache
18%Dizziness
18%Pyrexia
18%Stomatitis
16%Dermatitis Acneiform
16%Upper Respiratory Tract Infection
15%Pruritus
15%Cough
15%Anaemia
15%Abdominal Pain
15%Dyspnoea
13%Neutrophil Count Decreased
13%Nasopharyngitis
13%Dyspepsia
11%Epistaxis
11%Back Pain
11%Oedema Peripheral
10%Paraesthesia
10%Hypercholesterolaemia
8%Urinary Tract Infection
8%Pain in Extremity
8%Hot Flush
8%Aspartate Aminotransferase Increased
8%Hyperglycaemia
7%Nail Disorder
7%Onycholysis
7%Dysgeusia
7%Flushing
7%Musculoskeletal Chest Pain
7%Chest Discomfort
7%Gastritis
7%Hypoaesthesia
7%Abdominal Pain Upper
7%Rhinitis
7%Flatulence
7%Dry Eye
7%Mucosal Inflammation
7%Productive cough
7%Chest Pain
7%Influenza
7%Bone pain
7%Hypokalaemia
7%Depression
5%Pneumonia
5%Alanine Aminotransferase Increased
5%Musculoskeletal Pain
5%Hypertension
3%Anxiety
3%Febrile Neutropenia
3%Leukopenia
3%Dry Mouth
2%Decreased Appetite
2%Pancreatitis
2%Atypical Pneumonia
2%Retroperitoneal Infection
2%Spinal Cord Compression
2%Embolism
2%Wound Infection
2%Tuberculosis
2%Vascular device infection
2%Rash Maculo-Papular
Trial Design
1 Treatment Group
Treatment (paclitaxel, carboplatin, ipatasertib)
1 of 1
Experimental Treatment
24 Total Participants · 1 Treatment Group
Primary Treatment: Ipatasertib · No Placebo Group · Phase 1
Treatment (paclitaxel, carboplatin, ipatasertib)Experimental Group · 4 Interventions: Paclitaxel, Biopsy, Carboplatin, Ipatasertib · Intervention Types: Drug, Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~6440
Biopsy
2014
Completed Phase 4
~1120
Carboplatin
2014
Completed Phase 3
~7230
Ipatasertib
2011
Completed Phase 2
~1080
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within the first cycle of neoadjuvant chemotherapy (1 cycle = 21 days)
Who is running the clinical trial?
NRG OncologyOTHER
217 Previous Clinical Trials
94,104 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,070 Previous Clinical Trials
41,129,090 Total Patients Enrolled
Katherine C FuhPrincipal InvestigatorNRG Oncology
Eligibility Criteria
Age 18+ · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Genetic/genomic testing results will be a data collection element if performed as part of usual care (germline genetic testing, tumor genomic testing, homologous recombination deficiency [HRD] testing).
You have a high grade serous ovarian cancer.
You have an unresectable disease that is considered to be in need of NACT prior to debulking surgery.
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Conditions
Cancer Related
Treatments