University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 3C-09-1


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.

Type: Treatment
Phase: Phase II
Status: Not Open (Closed)
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Heinz Josef Lenz, M.D.
Other Trial Staff:  Ramona Lujan, R.N., Jiayi Jiang, D.M., Noureddine Miloud, D.M., Carol Jones, R.N.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
118 years or older.
2Histologically 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).
3A 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.
4A 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.
5Prior treatment with at least two regimens including a fluoropyrimidine, irinotecan and oxaliplatin. Progressive disease within the prior six months.
6Patients will be allowed into this trial if they have progressed after a clinical trial in which an investigational agent or agents have been used.
7ECOG Performance Status 0 or 1
8Estimated life expectancy of 16 weeks or more
9Adequate 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.
10Evidence 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).
11The 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.
12Full and complete recovery from major thoracic or abdominal surgery.
13Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.


You may not participate in this study if:
1Previous treatment with PARP inhibitors, including olaparib.
2Patients 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.
3Patients 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.
4Persistent CTCAE grade 2 or greater toxicities (excluding alopecia and neuropathy) caused by prior therapy.
5Patients 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.
6Patients currently experiencing seizures or who are currently being treated with any anti-epileptic for seizures.
7Patients requiring treatment with potent inhibitors or inducers of CYP3A4
8Patients 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.
9Presence 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.
10Patients who are unable to swallow orally administered medication.
11Patients who are immunocompromised, i.e.: patients known to be serologically positive for human immunodeficiency virus (HIV) and patients with disorders requiring chronic immunosuppressive agents.
12A positive pregnancy test. Patients must be willing to use effective methods of contraception
13Women who are breast feeding at the time of entry into the trial
14Simultaneous 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.
15Known hypersensitivity to olaparib or any of the excipients in olaparib.
16Patients 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
17An 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.
18Refrain from drinking grapefruit juice and eating star fruit while taking the study medication.
19Patients 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 clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.