A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have not Progressed after First Line Chemotherapy for EpithelialOvarian, Fallopian Tube, or Primary Peritoneal Cancer - ND

Phase 1

• Conditions: Women with FIGO Stage II, Stage III, and Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer has not progressed on first line chemotherapy.; MedDRA version: 12.0Level: LLTClassification code 10033128Term: Ovarian cancer

• Registration Number: EUCTR2008-004672-50-IT
• Lead Sponsor: GlaxoSmithkline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-20
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

1. Subject has provided written informed consent prior to performance of study-specific procedures or assessments, and is willing to comply with treatment and follow-up.
Note: Procedures conducted as part of the subject?s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures meet
the protocol requirements.
2. Subject is ≥ 18 years old.
3. Subject has 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. Note: Intravenous, intraperitoneal, or neoadjuvant platinum-taxane doublet chemotherapy are allowed;
for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed; second look is also allowed, as long as neither procedure is related to, or
does indicate, disease progression.
4. The date of study randomization must be 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.
5. Subject has had no evidence of disease progression throughout their first-line treatment and prior to study randomization, including
-CT or MRI scan taken within 6 weeks prior to randomization showing no
radiological progression, and
-CA-125 measurement taken within 6 weeks prior to randomization showing no CA-
125 progression, and
- no other clinical evidence of disease progression.
6. Subject has ECOG status of 0 or 1.
7. Subject is able to swallow and retain oral medication
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has either (a) bulky disease (eg, ascites that causes abdominal distention or
requires paracentesis; mesenteric thickening; or tumor masses of 2 cm or more by CT or MRI identified on the baseline scan), or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
2. Subjects with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
FIGO Stage ≤ IB, and
No lymphovascular invasion, and
Not poorly differentiated (i.e. not Grade 3 or papillary serous or clear cell)
3. Subject has clinically significant gastrointestinal abnormalities including, but not limited to:
Malabsorption syndrome
Major resection of the stomach or small bowel that could affect the absorption of study drug (eg, short bowel syndrome)
Active peptic ulcer disease
Known intraluminal metastatic lesion/s with suspected bleeding
Inflammatory bowel disease
Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
4. Subject has prolongation of corrected QT interval (QTc) > 480 msecs in the Screening ECG.
5. Subject has a history of any one or more of the following 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, as defined by the New York Heart Association (NYHA)
6. Subject has poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. At Screening, blood pressure must be assessed on at least two
occasions that are separated by a minimum of 24 hours. The mean SBP / DBP
values from each blood pressure assessment must be < 140/90mmHg in order for a subject to be eligible for the study.
7. Subject has a history of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within
the past 6 months prior to randomization.
Note: Subjects with recent DVT who have been treated with therapeutic anticoagulating agents for at least 6 weeks are eligible.
8. Subject has had major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures (eg, central venous access line removal) within 7
days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
9. Subject has evidence of active bleeding or bleeding diathesis.
10. Subject has had hemoptysis within 6 weeks prior to randomization.
11. Subject has known endobronchial metastases.
12. Subject has any 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.
13. Subject has been administered an investigational or anti-VEGF anticancer therapy prior to study randomization. Schedule, route, and dose variations of registered drugs do not account for investigational drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified