# Ipatasertib

Source: https://onco.cc/drugs/ipatasertib/  
OnCo record `ipatasertib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ipatasertib is an experimental small-molecule drug from Hoffmann-La Roche in phase 3 trials for HR-positive / HER2-negative breast cancer and ovarian cancer, aimed at AKT.

## Summary

Ipatasertib (GDC-0068, RO5532961, RG7440) is a small-molecule drug developed by Hoffmann-La Roche. Its target is AKT (the sponsor names AKT). ClinicalTrials.gov describes the intervention as: For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \< 35 kg, 300 mg for participants ≥35 and \< 45 kg, 400 mg for those ≥ 45 kg orally QD, beginning of Cycle 1, on Days 1-21. It is the investigational product in 5 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT05862285 (A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study), in HR-positive / HER2-negative breast cancer and ovarian cancer. The largest, NCT03424005, plans to enrol 1132 participants with primary completion expected 2030-09-30. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Code: GDC-0068, RO5532961, RG7440
- Modality: small molecule
- Mechanism: Small-molecule drug directed at AKT, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.

## Notes

- Triple-negative breast cancer: IPATunity130 cohort A (255 patients with PIK3CA, AKT1 or PTEN-altered advanced disease, first-line paclitaxel with or without ipatasertib) showed no progression-free survival difference (7.4 versus 6.1 months, hazard ratio 1.02) and no overall survival difference (24.4 versus 24.9 months), failing to confirm the phase 2 LOTUS signal; grade 3 or worse diarrhoea was 9 versus 2 percent. The UK BARBICAN phase 2 (146 patients, Barts) tests its contribution to neoadjuvant chemotherapy with atezolizumab.

## Sources

- ClinicalTrials.gov: trials of Ipatasertib: https://clinicaltrials.gov/search?intr=GDC-0068
- IPATunity130 cohort A (Clinical Cancer Research 2024): https://doi.org/10.1158/1078-0432.CCR-24-0465

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- targets: [AKT](https://onco.cc/targets/akt/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- trials: [A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study](https://onco.cc/trials/nct05862285/), [A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors](https://onco.cc/trials/nct04931342/), [A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer](https://onco.cc/trials/nct04802759/), [A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer](https://onco.cc/trials/nct03424005/), [BARBICAN](https://onco.cc/trials/barbican/), [CUPISCO](https://onco.cc/trials/cupisco/), [IPATunity130](https://onco.cc/trials/ipatunity130/), [LOTUS](https://onco.cc/trials/lotus/), [Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study](https://onco.cc/trials/nct04589845/)
- key papers: [Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial](https://onco.cc/key-papers/paper-kim-lotus-ipatasertib-tnbc-lancet-oncol-2017/), [IPATential150: ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer](https://onco.cc/key-papers/paper-ipatential150-ipatasertib-abiraterone-pten-lancet-2021/)

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