A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination with Other Anticancer Agents in Patients with a Solid Tumor

NOT ENROLLING
Protocol # :
19-168
Conditions
Ovarian Cancer
Triple-negative Breast Cancer
Urothelial Carcinoma
Solid Tumor
Phase
I/II
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Shapiro, Geoffrey, I.
Site Research Nurses
Carey, Margaret, M.
DeGonge, Danielle
Gillen Mckay, Christine, A.
Harran, John
Hedglin, Jennifer
Powers, Allison
Rang, Bethany

Trial Description

This is an open label, Phase 1b/2 study with multiple treatment arms evaluating the safety,
tolerability, pharmacokinetics (PK), and preliminary efficacy of rucaparib in combination
with a second anticancer therapy in participants with an advanced/metastatic solid malignancy
(Phase 1b), followed by evaluation of the combination in one or more specific participant
populations in an expansion phase (Phase 2 cohorts).

Eligibility Requirements

Inclusion Criteria Phase 1b (all arms):

- Solid tumor, advanced or metastatic, progressed on standard treatment participants in
Arm B must have either triple negative breast cancer OR urothelial carcinoma OR
ovarian cancer OR have a solid tumor with a deleterious mutation in BRCA1, BRCA2,
PALB2, RAD51C or RAD51D

- Measurable disease per RECIST v1.1

- Adequate organ function

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

- Tumor tissue for genomic analysis

Exclusion Criteria Phase 1b (all arms):

- Known history of myelodysplastic syndrome (MDS)

- Symptomatic and/or untreated central nervous system (CNS) metastases

Inclusion Criteria Phase 2 (all arms):

- Histologically or cytologically confirmed solid tumor, previously treated and
measurable per RECIST v1.1, as follows:

- Arm A: ovarian cancer with gBRCAwt disease, either platinum-sensitive OR
platinum-resistant

- Arm B: Metastatic triple negative breast cancer OR advanced/ metastatic urothelial
carcinoma OR relapsed ovarian cancer

- At least 1 prior line of standard therapy for advanced disease

- Adequate organ function

- ECOG 0 or 1

- Tumor tissue for genomic analysis

Exclusion Criteria Phase 2 (all arms):

- Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor treatment
allowed for participants with ovarian cancer

- Known history of MDS

- Symptomatic and/or untreated CNS metastases

19-168