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Monoclonal Antibodies

Ipatasertib for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 months
Awards & highlights

Study Summary

This trial is testing a new combo drug for men with mCRPC who have failed second-gen AR therapy. It's looking at safety and efficacy and will have around 50 participants.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prostate-Specific Antigen
Overall Response Rate (ORR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
Clinical Benefit Rate (CBR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
Documented Objective Response (DOR) (In participants presenting with measurable visceral disease or measurable extrapelvic adenopathy at baseline)
Overall Survival (OS) (median OS and landmark survival at 12, 18 and 24 months)
+5 more

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
9%
Dizziness
9%
Cough
9%
Rhinorrhoea
9%
Urticaria
9%
Leukopenia
9%
Gamma-glutamyltransferase increased
9%
Peripheral sensory neuropathy
9%
Weight decreased
9%
Hypokalaemia
9%
Arthralgia
9%
Insomnia
7%
Epistaxis
7%
Hypomagnesaemia
7%
Lymphocyte count decreased
7%
Stomatitis
7%
Back pain
7%
Dyspepsia
7%
Urinary tract infection
7%
Infusion related reaction
7%
Illness
7%
Pruritus
7%
Hyperbilirubinaemia
7%
Lymphoedema
7%
Abdominal discomfort
7%
Gastrooesophageal reflux disease
5%
Cellulitis
5%
Septic shock
5%
Polyneuropathy
5%
COVID-19
5%
Hyponatraemia
5%
Headache
5%
Abdominal pain
5%
Oedema peripheral
5%
Hypothyroidism
5%
Bone pain
5%
Dyspnoea
5%
Erythema
5%
Blood glucose increased
5%
Lymphopenia
2%
Musculoskeletal pain
2%
Cholecystitis infective
2%
Pyelonephritis
2%
Blood albumin decreased
2%
Gastritis
2%
Glycosylated haemoglobin increased
2%
Hypernatraemia
2%
Dehydration
2%
COVID-19 pneumonia
2%
Hypersensitivity
2%
Upper gastrointestinal haemorrhage
2%
Clostridium difficile colitis
2%
Drug eruption
2%
Lipase increased
2%
Hypocalcaemia
2%
Pleural effusion
2%
Hyperkalaemia
2%
Eczema
2%
Accidental overdose
2%
Acute kidney injury
2%
Blood lactate dehydrogenase increased
2%
Blood cholesterol increased
2%
Rash maculo-papular
2%
Dry mouth
2%
Neurotoxicity
100%
80%
60%
40%
20%
0%
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: Ipatasertib + Atezolizumab + DocetaxelExperimental Treatment3 Interventions
Part A (Safety Run-In): 12 Participants will be administered Ipatasertib orally once a day [QD] from Day 1 to Day 14 in combination with Atezolizumab administered by intravenous (IV infusion) every 3 weeks (Q3W) on Day 1 of each cycle (a cycle being 21 days) and Docetaxel administered by IV infusion (Q3W) on Day 1 of each cycle. Docetaxel will be administered for a maximum of 10 cycles (approximately 7 months), after which Atezolizumab and Ipatasertib will be administered as a doublet until disease progression. During Part A, a staggered recruitment will be applied to the first and potentially first 6 participants to enrol a participant only once the former one has safely overcome the safety time window (Cycle 1). Part B (Expansion): 38 Participants will be administered Ipatasertib, Atezolizumab and Docetaxel as described above, though without a staggered enrolment or safety assessment window.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2011
Completed Phase 3
~2320
Atezolizumab
2017
Completed Phase 3
~5860
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,391 Total Patients Enrolled
2 Trials studying Prostate Cancer
119 Patients Enrolled for Prostate Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,726 Total Patients Enrolled
3 Trials studying Prostate Cancer
417 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).
2020. "A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04404140.
~1 spots leftby Apr 2025
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