Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

Part of paid clinical trials in Edmonds, Washington.

Sponsor
Swedish Medical Center
Study ID
NCT01650376
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    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.
  • Carboplatin — DRUG
    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.
  • Paclitaxel — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2012
Status verified
Feb 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib plus carboplatin and paclitaxel

Primary Outcome Measure

Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Swedish Cancer Institute Edmonds CampusEdmondsWashington98026-
Swedish Cancer Institute Issaquah CampusIssaquahWashington98029-
Pacific Gynecology SpecialistsSeattleWashington98104-
Swedish Cancer Institute Ballard CampusSeattleWashington98107-
Swedish Medical Center Cancer InstituteSeattleWashington98104-

Find similar trials in Edmonds, WA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Swedish Cancer Institute Edmonds Campus· Edmonds, WASwedish Cancer Institute Issaquah Campus· Issaquah, WAPacific Gynecology Specialists· Seattle, WASwedish Cancer Institute Ballard Campus· Seattle, WASwedish Medical Center Cancer Institute· Seattle, WA

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