Trial record 1 of 1 for:    ISS22810034
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Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

This study is currently recruiting participants.
Verified July 2013 by Swedish Medical Center
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01650376
First received: July 18, 2012
Last updated: July 23, 2013
Last verified: July 2013

July 18, 2012
July 23, 2013
August 2012
August 2014   (final data collection date for primary outcome measure)
Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 1 cycle (1 cycle = 28 days) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01650376 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: Yes ]
Same as current
  • Response to Therapy [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ] [ Designated as safety issue: Yes ]
  • Time to Progression [ Time Frame: Measured by CT scans performed every 8 weeks while receiving treatment. (Anticipated time of 6 months) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Following the last treatment, patient's condition will be monitored every 3 months until death. ] [ Designated as safety issue: No ]
Same as current
 
Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer
Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Uterine Cancer
  • Drug: Olaparib
    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.
    Other Names:
    • AZD-2281
    • AZD2281
    • AZD 2281
  • Drug: Carboplatin
    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.
    Other Names:
    • Paraplatin
    • Paraplatin NovaPlus
  • Drug: Paclitaxel
    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.
    Other Names:
    • Taxol
    • Onxol
    • Nov-Onxol
    • Paclitaxel Novaplus
Experimental: Olaparib plus carboplatin and paclitaxel
Interventions:
  • Drug: Olaparib
  • Drug: Carboplatin
  • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
February 2015
August 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Barry Boatman, RN, MA, OCN (206) 215-3086 CancerResearch@Swedish.org
United States
 
NCT01650376
ISS22810034
No
Swedish Medical Center
Swedish Medical Center
AstraZeneca
Principal Investigator: Saul Rivkin, MD Swedish Medical Center Cancer Institute
Swedish Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP