Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer

Not Applicable

• Conditions: -C539 Cervix uteri, unspecified; Cervix uteri, unspecified; C539

• Registration Number: PER-112-06
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Written informed consent signed before performing any procedure related to the study.
2. Female patients ≥18 years of age.
3. Life expectancy of at least 12 weeks.
4. Performance condition according to the Cooperative Group in Eastern Oncology (ECOG) in 0 or 1.
5. Cervical cancer histologically confirmed in stage IVB according to FIGO, or squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the recurrent or persistent cervix that is not amenable to a curative treatment with surgery and / or radiation therapy.
6. Measurable disease.
7. At least one white lesion.
8. Not having received any chemotherapy regimen or having received a chemotherapy regimen previously for metastatic disease.
9. Having recovered from the effects of surgery or chemotherapy.
10. Proper functioning of the organs and bone marrow.
11. Ability to swallow and retain medication administered orally.
12. A woman is eligible to enter and participate in the present study if: a) She is not able to have family. b) Being able to have a family, has a negative result in a serum test to diagnose pregnancy within 2 weeks prior to receiving the first dose of study medication and agrees to use adequate contraception during their participation in
the study; and for a minimum of 2 menstrual cycles after receiving the last dose of study medication.
13. Patients must complete all screening evaluations, as outlined in the protocol.

Exclusion Criteria

1. Neuroendocrine carcinoma or carcinoma of the small cell cervix.
2. Previous use of some biological therapy with inhibitors of VEGF, VEGFR or ErbB2 / ErbB2 receptors.
3. Concurrent therapy against cancer.
4. Concurrent treatment with an agent in research or participation in another clinical trial.
5. Use of a cancer research drug within 28 days or for 5 half-lives, whichever is longer, before the first dose of study medication is given.
6. Have taken or are taking prohibited medications.
7. Any other serious and / or unstable medical, psychiatric, or any other condition that could interfere with the patient´s safety.
8. History of another malignancy.
9. History or clinical evidence of metastasis in the central nervous system or with leptomeningeal carcinomatosis.
10. Malabsorption syndrome, a disease that significantly affects gastrointestinal functioning or gastric or small bowel resection.
11. Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition that increases the risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess in the 4 weeks before starting therapy.
12. Presence of an uncontrolled infection.
13. Reactions of immediate, delayed hypersensitivity known, or idiosyncratic to drugs chemically related to pazopanib.
14. Prolongation of the corrected QT interval (QTc).
15. History of any of the following cardiac conditions in the last 6 months: a) Cardiac angioplasty or placement of a cardiac implant (stent). b) Myocardial infarction. c) Unstable angina.
16. History of a stroke or pulmonary embolism in the last 6 months.
17. With heart failure of functional grades III or IV.
18. Poorly controlled hypertension.
19. History of deep vein thrombosis (DVT) not treated during the last 6 months.
20. Presence of any wound, fracture, or ulcer that does not heal, or the presence of symptomatic peripheral vascular disease.
21. Patients with bilateral hydronephrosis that can not be relieved by the placement of ureteral implants (stents) or percutaneous drainage.
22. A major surgical procedure, an open biopsy or a significant traumatic injury within 4 weeks prior to initiating therapy, or anticipating the need to undergo a major surgical procedure during the course of the study; It also excludes patients who undergo minor surgical procedures.
23. Inability to swallow and retain medication administered orally.
24. Pregnant woman or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Evaluation of the time from the start of the medication to the progression, defined as: 1) Increase by at least 20% in the sum of the largest diameters of white lesions. 2) Occurrence of 1 or more injuries and / or unambiguous progression of non-white lesions. The lesions should be confirmed with CT, MRI and / or biopsy.<br>Measure:Free Survival of Progression.<br>Timepoints:At 52 weeks.<br>