Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

Inclusion Criteria:

- The female participant had a diagnosis of one of the following: a) low-grade serous
ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or
well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline
ovarian or peritoneal tumor, ovarian or peritoneal tumor of low-malignant potential,
ovarian or peritoneal atypical proliferative serous tumor that recurs as low grade
serous carcinoma or has invasive peritoneal implants

- The participant had at least one prior line of systemic therapy and had a tumor, which
was not amenable to potentially curative surgical resection

- The participant had measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1

- The participant had read and understood the written informed consent form (ICF) and
was willing and able to gave informed consent, fully understood the requirements of
the trial and was willing to comply with all trial visits and assessments, including
completion of patient-reported measures. Consent must be given before any trial
related activities

- Women of childbearing potential must had a negative serum pregnancy test at the
screening visit

- Women of childbearing potential must be willing to avoid pregnancy by using an
adequate method of contraception for 2 weeks prior to screening, during and at least 3
months after the last dose of trial medication

- Other protocol defined inclusion criteria may apply

Exclusion Criteria:

- The participant had previously been treated with a PI3K inhibitor and taken off
treatment due to treatment related AEs

- The participant had been previously treated with a Mitogen-activated
protein/extracellular signal-regulated kinase (MEK) inhibitor

- Any anti-cancer therapy or treatment incorporating chemotherapy, immunotherapy,
hormonal therapy, or biologic therapy within 28 days of the start of trial treatment
or within 5 times the half-life of such treatment, whichever was shorter. Treatment
with nitrosoureas or mitomycin C were exceptions to this for which a treatment
interval of at least 6 weeks was required

- The participant had not recovered from toxicity due to prior therapy to baseline level
or National Cancer Institute Common Terminology Criteria for Adverse Events Version
4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). Residual chemotherapy-induced
neuropathy grade less than equal to (<=) 2 was permitted

- The participant had poor organ and marrow function as defined in the protocol

- The participant had creatine phosphokinase (CPK) elevation NCI CTCAE grade greater
than equal to (>=) 2, and/or a previous history of myositis or rhabdomyolysis

- The participant had difficulty swallowing, malabsorption or other chronic
gastrointestinal disease or conditions that may hamper compliance and/or absorption of
the trial drug. Participants requiring total parenteral nutrition were to be excluded

- The participant had a history of delayed healing/open wounds or diabetic ulcers

- The participant had a history of congestive heart failure, unstable angina, myocardial
infarction, cardiac conduction abnormalities including Fridericia corrected QT
interval (QTcF) prolongation of > 480 milliseconds (ms) or a pacemaker, clinically
relevant impaired cardiovascular function (New York Heart Association (NYHA) class
III/IV) or stroke within 3 months prior to enrollment

- The participant had a history of retinal degenerative disease (hereditary retinal
degeneration or age-related macular degeneration), uveitis or retinal vein occlusion
(RVO), or had other relevant abnormalities identified on screening ophthalmologic
examination, which might increase the risk of serous retinal detachment (SRD) or RVO

- The participant had a history of uncontrolled intercurrent illness including but not
limited to an active infection, hypertension, or uncontrolled diabetes (e.g.
glycosylated hemoglobin >= 8 percent [%]) that would limit compliance with treatment
requirements

- Any previous malignancy treated with curative intent and the participant had been
disease free for less than 5 years prior to randomization, with exception of
carcinoma‐in‐situ of the cervix, squamous carcinoma of the skin, basal cell carcinoma
of the skin

- Other protocol defined exclusion criteria may apply