Efficacy and Safety of Pazopanib Monotherapy After First-line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Asian Women

NCT01227928 | Completed Phase 2 Results DMC

• 1 other identifier: 114012
• Study Type: interventional
• Target: 145
• Locations: 4 countries
• Sites: 15

Brief Summary

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

Conditions

Neoplasms, Ovarian

Keywords

tyrosine kinase inhibitors; Primary Peritoneal Carcinoma; primary peritoneal cancer; ovarian cancer; Fallopian Tube Cancer; gynecologic cancer; anti-angiogenesis; pazopanib

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.

  From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)

Secondary Outcomes (14)

• Overall Survival

  From randomization until death due to any cause (average of 29.4 months)

• PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria

  From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months)

• Number of Participants With Any Dose Reduction or Any Dose Interruption

  From Week 1 until the end of the treatment period (up to Study Week 108)

• Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)

  From Week 1 until the end of the treatment period (up to Study Week 108)

• Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment

  From Week 1 until the end of the treatment period (up to Study Week 108)

Study Arms (2)

pazopanib

EXPERIMENTAL

experimental medication

Drug: Pazopanib

placebo

PLACEBO COMPARATOR

placebo comparator

Drug: Placebo comparator

Interventions

Pazopanib DRUG

Pazopanib 800 mg daily for 24 months

pazopanib

Placebo comparator DRUG

Placebo 800 mg daily for 24 months

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• At least 18 years old.
• Histologically confirmed, International Federation of Gynecology and Obstetrics (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
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 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

You may not qualify if:

• 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
• 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.
• Prior or concurrent invasive malignancies that currently or within the last 5 years show/ed activity of disease (except ovarian, fallopian tube, or peritoneal cancer, or concurrent endometrial cancer FIGO stages IA/B)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Guangzhou, Guangdong, China

Location

GSK Investigational Site

Nanjing, Jiangsu, 210009, China

Location

GSK Investigational Site

Shenyang, Liaoning, 110022, China

Location

GSK Investigational Site

Jinan, Shandong, 250012, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610041, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310006, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310022, China

Location

GSK Investigational Site

Beijing, 100021, China

Location

GSK Investigational Site

Beijing, 100044, China

Location

GSK Investigational Site

Beijing, 100853, China

Location

GSK Investigational Site

Shanghai, 200032, China

Location

GSK Investigational Site

Hong Kong, Hong Kong

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Taipei, 104, Taiwan

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

Related Publications (1)

• Kim JW, Mahner S, Wu LY, Shoji T, Kim BG, Zhu JQ, Takano T, Park SY, Kong BH, Wu Q, Wang KL, Ngan HY, Liu JH, Wei LH, Mitrica I, Zhang P, Crescenzo R, Wang Q, Cox CJ, Harter P, du Bois A. Pazopanib Maintenance Therapy in East Asian Women With Advanced Epithelial Ovarian Cancer: Results From AGO-OVAR16 and an East Asian Study. Int J Gynecol Cancer. 2018 Jan;28(1):2-10. doi: 10.1097/IGC.0000000000000602.

  PMID: 26588236 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2014
• Last Updated: March 3, 2015
• Results First Posted: June 4, 2013

Record last verified: 2015-02

Locations

TW (2); KR (1); CN (11); HK (1)