A Phase 1/2 interventional study of Olaparib and Carboplatin in Stage III Ovarian Cancer, Stage IV Ovarian Cancer and Uterine Cancer, sponsored by Swedish Medical Center. Status unknown at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by Swedish Medical Center · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the maximum tolerated dose (MTD) of the investigational agent, olaparib, to give in combination with carboplatin and paclitaxel in patients with relapsed ovarian cancer or uterine cancer. Furthermore, the investigators intend to study the safety and tolerability of the study treatment, response to treatment, time to disease progression, and overall survival.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 52 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Swedish Medical Center is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Advanced (stage III or IV), histologically or cytologically documented ovarian cancer or serious uterine cancer patients who relapsed after primary therapy with a platinum and a taxane. This includes:
Must have normal organ and bone marrow function defined as follows:
Exclusion Criteria:
Drug: Olaparib · Drug: Carboplatin · Drug: Paclitaxel
Olaparib will be administered orally on Days 1, 2, and 3 of each week until DLT or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of olaparib is 50, 100, 150 and 200 mg, taken twice a day will be used.
Also known as: AZD-2281, AZD2281, AZD 2281
AUC 2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.
Also known as: Paraplatin, Paraplatin NovaPlus
60mg/m2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.
Also known as: Taxol, Onxol, Nov-Onxol, Paclitaxel Novaplus
Incidence of Dose Limiting Toxicity (DLT)
Time frame: 1 cycle (1 cycle = 28 days)
Number of Reported Adverse Events
Time frame: Weekly assessments of clinical and laboratory values, and vital sign measurements performed while receiving study treatment. (Anticipated time of 6 months)
Response to Therapy
Time frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months)
Time to Progression
Time frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months)
Overall Survival
Time frame: Following the last treatment, patient's condition will be monitored every 3 months until death.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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