Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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Novartis

Status and phase

Completed
Phase 3

Conditions

Ovarian Cancer

Treatments

Drug: Placebo
Drug: Pazopanib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00866697
2008-004672-50 (EudraCT Number)
CPZP034C2301 (Other Identifier)
110655

Details and patient eligibility

About

This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.

Full description

This was a randomized, two-arm, placebo controlled, double-blind, multicenter, intergroup Phase III study in women with non-bulky FIGO (International Federation of Gynecology and Obstetrics) Stage II - IV ovarian, fallopian tube, or primary peritoneal cancer that had not progressed (i.e., complete response (CR), partial response (PR), stable disease (SD) after completing their first-line chemotherapy for advanced ovarian cancer. Approximately 900 subjects were to be enrolled into the study. Study was closed following 3rd overall survival (OS) interim analysis as planned per protocol, which confirmed futility.

Enrollment

940 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • written informed consent
  • At least 18 years old.
  • Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
  • Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
  • No evidence of disease progression
  • ECOG status of 0 or 2
  • Able to swallow and retain oral medication.
  • Adequate hematologic, hepatic, and renal system function as follows:

Hematologic

  • Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
  • Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
  • Platelets at least 100 X 10^9/L
  • Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
  • Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
  • Total bilirubin up to 1.5 X ULN
  • AST and ALT up to 2.5 X ULN Renal
  • Serum creatinine up to 1.5 mg/dL

Or, if greater than 1.5 mg/dL:

Calculated creatinine clearance at least 50 mL/min Urine Protein

  • Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24- hour urine protein analysis.
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.

Exclusion criteria

  • Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy

  • Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.

  • Clinically significant gastrointestinal abnormalities

  • Prolongation of corrected QT interval (QTc) > 480 msecs

  • History of any one or more cardiovascular conditions within the past 6 months prior to randomization

  • Cardiac angioplasty or stenting

  • Myocardial infarction

  • Unstable angina

  • Symptomatic peripheral vascular disease

    • Class III or IV congestive heart failure
  • Poorly controlled hypertension

  • History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization

  • Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.

  • Evidence of active bleeding or bleeding diathesis.

  • Hemoptysis within 6 weeks prior to randomization.

  • Endobronchial metastases.

  • Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.

  • Investigational or anti-VEGF anticancer therapy prior to study randomization.

  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib

  • Invasive malignancies that showed activity of disease within 5 years prior to randomization

Trial design

940 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
matched placebo tablet administered orally once daily for up to 24 months
Treatment:
Drug: Placebo
Pazopanib
Experimental group
Description:
Pazopanib tablet administered orally at 800 mg once daily for up to 24 months
Treatment:
Drug: Pazopanib

Trial documents
1

Trial contacts and locations

318

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Data sourced from clinicaltrials.gov

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