A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.

Completed · Phase 1

Conditions studied: Breast Cancer, Prostate Cancer, Ovarian Cancer

In brief

This is a study in participants with advanced breast, ovarian, or prostate cancer to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of ipatasertib in combination with rucaparib. The study consists of two parts: a Dose-Escalation Phase (Part 1) in participants with previously treated advanced breast cancer, ovarian cancer, or prostate cancer and a Dose-Expansion Phase (Part 2) in participants with advanced prostate cancer who have had at least one line of prior therapy with second-generation androgen-receptor (AR)-targeted agents (e.g., abiraterone, enzalutamide, apalutamide).

Key facts

Study ID: NCT03840200
Run by: Hoffmann-La Roche
People needed: 51
Starts: 2019-06-12
Expected to finish: 2022-01-04
Last updated by the study team: 2023-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
A life expectancy of at least 3 months
Ability to swallow oral study drug
Have adequate organ and marrow function as confirmed by the laboratory values listed below, obtained within 28 days prior to the first dose of study treatment:
Bone marrow function assessments (without transfusion within 28 days prior to receipt of study treatment):
ANC >= 1500 cells/uL (1.5 x 10\^9/L) without granulocyte-colony stimulating factor support
Platelet count >= 100.0 x 10\^9/L
Hemoglobin >= 9 g/dL (or 5.6 mmol/L)
Chemistry panel assessments:
AST and ALT <= 1.5 x upper limit of normal (ULN); if liver metastases, <= 2.5 x ULN
Bilirubin <= 1.5 x ULN (<= 3 x ULN if hyperbilirubinemia is due to Gilbert's syndrome)
Serum albumin >= 3.0 g/dL
Serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min
Fasting glucose <= 150 mg/dL and hemoglobin A1c <= 7.5%
Resolved or stabilized toxicities resulting from previous therapy to Grade 1 (except for alopecia and neuropathy).
Cancer-Related Inclusion Criteria
Have a histologically confirmed diagnosis of ovarian (Part 1 only), breast (Part 1 only) or prostate cancer (Part 1 and Part 2)
Disease must be either metastatic or locally advanced disease that cannot be treated with curative intent
For patients with ovarian cancer (Part 1 only):
High-grade (2 or 3) serous or endometrioid or clear cell epithelial ovarian, fallopian tube, or primary peritoneal cancer (PPC)
Must have received at least one prior platinum-based therapy and may have platinumsensitive disease (i.e., documented radiologic disease progression >= 6 months following the last dose of the platinum treatment administered) or platinum-resistant disease
Have a CA-125 level that is > 2 x ULN
Must have measurable disease by RECIST v1.1
For patients with breast cancer (Part 1 only): must be human epidermal growth factor receptor 2 negative (HER2-) (estrogen receptor [ER]/progesterone positive or negative):
ER/progesterone-positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic)

You may not qualify if…

Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final dose of ipatasertib or 6 months after the final dose of rucaparib
Prior treatment with a PARP inhibitor, AKT inhibitor, or PI3K inhibitor
Treatment with investigational therapy within 14 days prior to initiation of study drug
Symptomatic and/or untreated CNS metastases
Uncontrolled tumor-related pain
Non-study-related minor surgical procedures <= 5 days or major (invasive) surgical procedure <=14 days prior to first dose of study treatment
Patients with active hepatitis C virus (HCV)
Hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test or a positive quantitative HBV DNA test
Known HIV infection
Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
Malabsorption syndrome or other condition that would interfere with enteral absorption
Serious infection requiring antibiotics within 14 days of first dose of study treatment
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Need for chronic corticosteroid therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
History of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low-grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of < 5% at 5 years.
History of clinically significant cardiovascular dysfunction
Presence of any other condition that may have increased the risk associated with study participation or may have interfered with the interpretation of study results, and, in the opinion of the investigator, would have made the patient inappropriate for entry into the study
Ipatasertib-Specific Exclusion Criteria:
Type 1 or Type 2 diabetes mellitus requiring insulin at study entry
History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)
Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 4 weeks or five elimination half-live of the inhibitors, whichever is longer, prior to initiation of study drug

Where it is running

California Cancer Associates for Research & Excellence, Inc. — San Marcos, California, United States
Regional Cancer Care Associates LLC, Central Jersey Division — East Brunswick, New Jersey, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Mary Crowley Medical Research Center; Oncology — Dallas, Texas, United States
Kinghorn Cancer Centre; St Vincents Hospital — Darlinghurst, New South Wales, Australia
Macquarie University Hospital — Macquarie Park, New South Wales, Australia
Cabrini Hospital Malvern — Malvern, Victoria, Australia
Istituto Nazionale Tumori Regina Elena IRCCS — Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2 — Milan, Lombardy, Italy
Azienda Ospedaliera Santa Maria di Terni — Terni, Umbria, Italy
Istituto Oncologico Veneto IRCCS — Padova, Veneto, Italy
Seoul National University Hospital — Seoul, South Korea
Severance Hospital, Yonsei University — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Clínica Universidad de Navarra — Pamplona, Navarre, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona — Barcelona, Spain
Hospital Universitario Virgen de la Victoria — Málaga, Spain

Full record on ClinicalTrials.gov

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