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A Phase II, Open-Label, Multi-Center Trial to Assess the Efficacy and Safety of the PARP Inhibitor, Olaparib, Alone in Previously-Treated Patients with Stage IV, Measurable Colorectal Cancer, Stratified by MSI Status.
Defintions of terms and FAQ about clinical trials.
Heinz Josef Lenz, M.D.
Other Trial Staff:
Ramona Lujan, R.N., Jiayi Jiang, D.M., Noureddine Miloud, D.M., Carol Jones, R.N.
to see study documents.
You may participate in this study if:
18 years or older.
Histologically proven stage disseminated CRC with measurable disease with at least one measurable lesion (at least 10 mm in the longest diameter (LD) by spiral CT scan, or 20 mm with conventional techniques).
A pathology specimen of the primary tumor (archival specimen allowed or a metastatic tumor lesion amenable to biopsy) must be available for microsatellite status determination prior to initiating therapy.
A pathology specimen of the primary tumor (archival specimen allowed or a metastatic tumor lesion amenable to biopsy) must be available for analysis of PARP-1 level, K-ras mutational status and b-raf mutational status.
Prior treatment with at least two regimens including a fluoropyrimidine, irinotecan and oxaliplatin. Progressive disease within the prior six months.
Patients will be allowed into this trial if they have progressed after a clinical trial in which an investigational agent or agents have been used.
ECOG Performance Status 0 or 1
Estimated life expectancy of 16 weeks or more
Adequate bone marrow, hepatic and renal function, defined as at least: Absolute neutrophil count greater than or equal to 1,500. Platelets greater than or equal to 100,000. Hemoglobin greater than or equal to 10. Albumin greater than or equal to 2.5. Total bilirubin less than or equal to 1.5 x ULN. AST and ALT less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN in the presence of liver metastases). Serum creatinine less than or equal to 1.5 x ULN.
Evidence of non-childbearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of childbearing potential, or postmenopausal status “Postmenopausal” is defined by any one of the following: - natural menopause with last menses >1 year ago; - radiation-induced oophorectomy with last menses >1 year ago, - chemotherapy-induced menopause with >1 year interval since last menses, - serum follicle stimulating hormone, luteinising hormone and plasma oestradiol levels in the post menopausal range for the institution,surgical sterilisation (bilateral oophorectomy or hysterectomy).
The patient must be willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
Full and complete recovery from major thoracic or abdominal surgery.
Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
You may not participate in this study if:
Previous treatment with PARP inhibitors, including olaparib.
Patients with symptomatic, uncontrolled brain metastases. Patients requiring steroids to control symptoms from brain metastases are excluded. A scan to confirm the absence of brain metastases is not required.
Patients with second primary cancer, (except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors including lymphomas without bone marrow involvement) curatively treated with no evidence of disease for greater than or equal to 5 years. The exception to this criterion is prostate cancer treated definitively with surgery and/or radiation with normal PSA and no clinical evidence of residual or recurrent prostate cancer.
Persistent CTCAE grade 2 or greater toxicities (excluding alopecia and neuropathy) caused by prior therapy.
Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used). Patients may continue the use of corticosteroids, provided the dose is stable during the study and has been started at least 4 weeks prior to enrollment.
Patients currently experiencing seizures or who are currently being treated with any anti-epileptic for seizures.
Patients requiring treatment with potent inhibitors or inducers of CYP3A4
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent MI, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
Presence of gastrointestinal disorders that, in the Investigator’s opinion, are likely to interfere with the absorption of olaparib or with the patient’s ability to take regular oral medication.
Patients who are unable to swallow orally administered medication.
Patients who are immunocompromised, i.e.: patients known to be serologically positive for human immunodeficiency virus (HIV) and patients with disorders requiring chronic immunosuppressive agents.
A positive pregnancy test. Patients must be willing to use effective methods of contraception
Women who are breast feeding at the time of entry into the trial
Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
Known hypersensitivity to olaparib or any of the excipients in olaparib.
Patients and their partners (of child bearing age) must agree to two highly effective forms of contraception during their participation in the study and for 3 months after the last dose of olaparib or matching placebo. Acceptable methods of birth control are defined as a barrier method in conjunction with spermicide (i.e. condom with spermicide), together with one of the following: oral contraceptive or hormonal therapy (e.g. hormone implants), placement of an intra-uterine device. Consideration should be given to the type of device/system used as certain types are less effective
An increased risk of infection by the administration of live virus and bacterial vaccines has been observed with conventional chemotherapy drugs. Effects with olaparib are unknown and therefore they should not be administered to patients in the study.
Refrain from drinking grapefruit juice and eating star fruit while taking the study medication.
Patients who are blood donors should not donate blood during the study, and for 3 months after the last dose of study medication.
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.