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

Information source: Swedish Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Uterine Cancer

Intervention: Olaparib (Drug); Carboplatin (Drug); Paclitaxel (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Swedish Medical Center

Official(s) and/or principal investigator(s):
Saul Rivkin, MD, Principal Investigator, Affiliation: Swedish Medical Center Cancer Institute


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.

Clinical Details

Official title: Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of Dose Limiting Toxicity (DLT)

Secondary outcome: Number of Reported Adverse Events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- 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:

- Platinum sensitive: relapsed at least 6 months following platinum treatment

- Platinum refractory: the cancer grew while on platinum treatment

- Platinum resistant: recurrence within 6 months of platinum treatment

- Must have failed first line treatment

- ECOG performance status 0-2

- Must be able to swallow and retain oral medication

- Life expectancy greater than 16 weeks

- Must have normal organ and bone marrow function defined as follows:

- Hemoglobin ≥ 9. 0 g/dL

- Absolute neutrophil count (ANC) ≥ 1. 5 x 10^9/L

- White blood cells (WBC) > 3 x 10^9/L

- Platelet count ≥ 100 10^9/L

- Total bilirubin ≤ 1. 5 x institutional upper limit of normal

- AST (SGOT)/ALT (SGPT) ≤ x institutional upper limit of normal unless liver

metastases are present in which case it must be ≤ 5 ULN

- Serum creatinine ≤ 1. 5 x institutional upper limit of normal (ULN)

Exclusion Criteria:

- Any previous treatment with a PARP inhibitor, including olaparib

- Any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2

weeks from the last dose prior to study treatment (or longer period depending on the defined characteristics of the agents used)

- Currently receiving the following classes of inhibitors of CYP3A4: azole antifungals,

macrolide antibiotics, and protease inhibitors

- Second primary cancer except adequately treated non-melanoma skin cancer, curatively

treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years

- Symptomatic uncontrolled brain metastases

- Major surgery within 2 weeks of starting study treatment

- Immunocompromised patients, e. g., patients who are known to be serologically positive

for human immunodeficiency virus (HIV)

- Known active hepatic disease (i. e. Hepatitis B or C)

- Uncontrolled seizures

- History of allergic reactions attributed to compounds of similar chemical or biologic

composition to carboplatin or paclitaxel

Locations and Contacts

Swedish Cancer Institute Edmonds Campus, Edmonds, Washington 98026, United States

Swedish Cancer Institute Issaquah Campus, Issaquah, Washington 98029, United States

Pacific Gynecology Specialists, Seattle, Washington 98104, United States

Swedish Cancer Institute Ballard Campus, Seattle, Washington 98107, United States

Swedish Medical Center Cancer Institute, Seattle, Washington 98104, United States

Additional Information

Starting date: August 2012
Last updated: June 4, 2015

Page last updated: August 23, 2015

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