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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Uterine Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of Dose Limiting Toxicity (DLT)

Outcome Time Frame:

1 cycle (1 cycle = 28 days)

Safety Issue:


Principal Investigator

Saul Rivkin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Medical Center Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

February 2015

Related Keywords:

  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Uterine Cancer
  • Ovarian Neoplasms
  • Cancer of the Ovary
  • Ovarian Cancer
  • Uterine Neoplasms
  • Cancer of the Uterus
  • Uterine Cancer
  • Olaparib
  • AZD2281
  • Carboplatin
  • Paclitaxel
  • Relapsed
  • Ovarian Neoplasms
  • Uterine Neoplasms



Swedish Medical Center Cancer Institute Seattle, Washington  98104