Neoplasms, Uterine CervixPhase 2NCT00430781

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

A Phase 2 study testing pazopanib (GW786034) and lapatinib (GW572016) in people with Neoplasms, Uterine Cervix and Metastatic Cervical Cancer, run by GlaxoSmithKline at 63 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Neoplasms, Uterine Cervix, Metastatic Cervical Cancer
What is being tested?: pazopanib (GW786034) and lapatinib (GW572016)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 63 sitesin 13 countries
Study dates: Nov 2006to Jul 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

A subject will be eligible for inclusion in this study only if all of the following criteria are met:
Signed, written informed consent prior to performing any study-related procedures
Female subjects ≥18 years of age
FIGO Stage IVB, or recurrent or persistent cervical cancer
Life expectancy of at least 12 weeks
ECOG status of 0 or 1.

Show all 36Show fewer

Histologically confirmed FIGO Stage IVB, or recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpitation, plain x-ray, CT and MRI, or ≥10 mm when measured by spiral CT.
At least one "target lesion" to be used to assess response as defined by Response Evaluation Criteria in Solid Tumors (RECIST; Terasse, 2000). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
Received 0 or 1 prior chemotherapy regimen for metastatic disease.
Note: Chemotherapy given in combination with radiation therapy as a radiosensitizer does not count toward this prior therapy limit
Recovered from the effects of surgery or chemotherapy. At least three weeks must have elapsed from the last administration of chemotherapy.
Adequate organ and bone marrow function as defined in Table 1.
Table 1:(Definitions for Adequate Organ Function)
System:(Laboratory Values)
Hematologic: Absolute neutrophil count (ANC)(≥ 1.5 X 109/L)Hemoglobin1(≥9 g/dL)Platelets(≥100 X 109/L)
Hepatic: Total bilirubin (≤1.5 X ULN)AST and ALT (≤2.5 X ULN)
Renal: Calculated creatinine clearance2 (≥50 mL/min)
Urine protein3 (Negative, trace or +1 by dipstick urinalysis or <1.0 gram determined by 24 hour urine protein analysis.)
Subjects may not have had a transfusion within 7 days of screening assessment.
Calculated by Cockcroft Gault formula See Appendix 7: Renal Function Tests
A patient should first be screened with dipstick urinalysis. If urine protein by dipstick analysis is ≥2+, then a 24-hour urine protein must be assessed and 24 hour urine protein must be <1 g protein to be eligible.
Ability to swallow and retain oral medication.
A female is eligible to enter and participate in this study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
A hysterectomy
A bilateral oophorectomy (ovariectomy)
A bilateral tubal ligation
Is post-menopausal (total cessation of menses for ≥ 1 year)
Childbearing potential, has a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
An intrauterine device with a documented failure rate of less than 1% per year.
Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, through the dosing period, and for at least 21 days after the last dose of investigational product.
Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
Note: Oral contraceptives are not reliable due to potential drug-drug interactions.
Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow-up as outlined in the protocol. Procedures conducted as apart of routine clinical management of the patient (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for screening purposes provided these tests are obtained as specified in the protocol

Who cannot join

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Neuroendocrine or small cell carcinoma of the cervix.
Prior use of any biologic therapy with VEGF, VEGFR, or ErbB1/ErbB2 inhibitors.
Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
Concurrent treatment with an investigational agent or participation in another clinical trial.
Use of an investigational anti-cancer drug within 28 days or 5 half-lives, whichever is longer, preceding the first dose of study medication.

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Has taken or is taking prohibited medications listed in the protocol.
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study.
History of another malignancy. Note: Patients who have had another malignancy and have been disease-free for 5 years, or patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Routine screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated.
Malabsorption Syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning therapy.
Presence of uncontrolled infection.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
Corrected QT interval (QTc) prolongation defined as QTc interval > 470 msecs.
History of any one of the following cardiac conditions within the past 6 months:
Cardiac angioplasty or stenting
Myocardial infarction
Unstable angina
History of cerebrovascular accident or pulmonary embolus within the past 6 months.
Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (See Appendix 6)
Poorly controlled hypertension (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. The blood pressure (BP) must be re-assessed on two occasions that are separated by a minimum of 24 hours. The mean SBP/DBP values from both BP assessments must be < 140/90mmHg in order for a subject to be eligible for the study.
History of untreated deep venous thrombosis (DVT) within the past 6 months (e.g. calf vein thrombosis).
Note: Patients with recent DVT who are treated with therapeutic anti-coagulant agents (excluding therapeutic warfarin) for at least 6 weeks are eligible.
Presence of any non-healing, non-tumor related wound, fracture, or ulcer, or the presence of symptomatic peripheral vascular disease.
Subjects with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.
Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedures such as fine needle aspiration or core biopsy within 1 week prior to beginning therapy are also excluded.
Unable to swallow and retain orally administered medication.
Pregnant or lactating female.

Trial locations and contacts

63 sites in 13 countries.

Country

City, postcode or hospital

63 sites in 13 countries

United States12 sites

GSK Investigational Site
Albuquerque, New Mexico, 87131-5276
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Chattanooga, Tennessee, 37403
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Columbus, Ohio, 43214
GSK Investigational Site
Dallas, Texas, 75390
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Stanford, California, 94305-5317

Other trials in United States

Argentina7 sites

GSK Investigational Site
Capital Federal, Buenos Aires, C1405CUB
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1185AAT
GSK Investigational Site
Neuquén, Neuquén Province, Q8300HDH
GSK Investigational Site
Quilmes, 1878
GSK Investigational Site
Rosario, Santa Fe Province, S2000KZE
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, 4000
GSK Investigational Site
Santa Fe, Santa Fe Province, 3000

Other trials in Argentina

France6 sites

GSK Investigational Site
Bordeaux, 33076
GSK Investigational Site
Caen, 14076
GSK Investigational Site
Lille, 59020
GSK Investigational Site
Marseille, 13273
GSK Investigational Site
Strasbourg, 67085
GSK Investigational Site
Villejuif, 94805

Other trials in France

Germany6 sites

GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 10367
GSK Investigational Site
Halle, Saxony-Anhalt, 06120
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39108
GSK Investigational Site
Munich, Bavaria, 80337
GSK Investigational Site
Saarbrücken, Saarland, 66113

Other trials in Germany

Spain6 sites

GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 08907
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), 38320
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Marid, 28040
GSK Investigational Site
Pamplona, 31008

Other trials in Spain

Belgium5 sites

GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Roeselare, 8800

Other trials in Belgium

Canada5 sites

GSK Investigational Site
Calgary, Alberta, T2N 4N2
GSK Investigational Site
Hamilton, Ontario, L8V 5C2
GSK Investigational Site
Montreal, Quebec, H2L 4M1
GSK Investigational Site
Toronto, Ontario, M5G 2M9
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

India4 sites

GSK Investigational Site
Ahemdabad, 380016
GSK Investigational Site
Mangalore, 575001
GSK Investigational Site
New Delhi, 110096
GSK Investigational Site
Trivandrum, 695011

Other trials in India

Italy4 sites

GSK Investigational Site
Bari, Apulia, 70124
GSK Investigational Site
Campobasso, Molise, 86100
GSK Investigational Site
Milan, Lombardy, 20141
GSK Investigational Site
Naples, Campania, 80131

Other trials in Italy

Thailand3 sites

GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Khon Kaen, 40002

Other trials in Thailand

Estonia2 sites

GSK Investigational Site
Tallinn, 11619
GSK Investigational Site
Tartu, 51003

Other trials in Estonia

Ireland2 sites

GSK Investigational Site
Cork
GSK Investigational Site
Dublin, 7

Other trials in Ireland

Mexico1 site

GSK Investigational Site
Mexico City, CP 14080

Other trials in Mexico

About this study

Official title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination With Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects With FIGO Stage IVB or Recurrent or Persistent Cervical Cancer With Zero or One Prior Chemotherapy Regimen

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

Read the detailed description

A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects with International Federation of Gynecology (FIGO) Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease

Conditions: Neoplasms, Uterine Cervix, Metastatic Cervical Cancer
Being tested: pazopanib (GW786034), lapatinib (GW572016)
Keywords: pazopanib, ErB1/ErB2, lapatinib, persistent, VEGF, recurrent, metastatic cervical cancer, advanced, FIGO Stage IVB
Medical subject headings: Neoplasms, Uterine Cervical Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pazopanib (GW786034)Drug
lapatinib (GW572016)Drug

Study groups in NCT00430781
Study group	Role	What they receive
Combination arm	Experimental	Pazopanib plus lapatinib Receives: Drug: lapatinib (GW572016)
Lapatinib monotherapy	Active comparator	Lapatinib Receives: Drug: lapatinib (GW572016)
Pazopanib monotherapy	Active comparator	Pazopanib Receives: Drug: pazopanib (GW786034)

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS) in Interim Analysis
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.
Measured: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)
Progression-free Survival (PFS) in Final Analysis
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.
Measured: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)

Secondary outcomes (6)

Overall Survival
Overall survival is defined as the time from randomization until death due to any cause.
Measured: From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)
Clinical Benefit Response
Clinical benefit response is defined as the number of participants with evidence of complete (CR) or partial (PR) tumor response or stable disease (SD) for at least 6 months (183 days). Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum; Stable Disease, small changes that do not meet previously given criteria. Confirmation requires at least 2 assessments of CR/PR with at least 4 weeks between assessments.
Measured: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Response
Response is defined as the number of participants achieving either a complete or partial tumor response per RECIST criteria. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Measured: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Time to Response
For the subset of participants who showed a confirmed CR or PR, time to response was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Measured: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Duration of Response
For participants who had a CR or PR, the duration of response was defined as the time from first documented evidence of PR or CR until the first documented sign of disease progression or death. CR, all detectable tumor has disappeared; PR, a >=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum.
Measured: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib
Safety was assessed as the number of participants experiencing a serious adverse event (SAE) or an adverse event (AE). See the adverse event module for safety data.
Measured: From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Jul 2011

First posted2 Feb 2007 (estimated)
Study startNov 2006
Primary completionJul 2008
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Neoplasms, Uterine CervixStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00430781
Sponsor's protocol ID: VEG105281
Status last verified: Apr 2015
First submitted: 31 Jan 2007
Last updated: 8 May 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.
PubMed 20606083
Monk BJ, Pandite LN. Survival data from a phase II, open-label study of pazopanib or lapatinib monotherapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2011 Dec 20;29(36):4845. doi: 10.1200/JCO.2011.38.8777. Epub 2011 Nov 14. No abstract available.
PubMed 22084371
de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.
PubMed 23054212

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination With Lapatinib (GW572016) Compared to Pazopanib Monotherapy and Lapatinib Monotherapy in Subjects With FIGO Stage IVB or Recurrent or Persistent Cervical Cancer With Zero or One Prior Chemotherapy Regimen
ClinicalTrials.gov ID: NCT00430781
Acronym / sponsor ID: VEG105281
Conditions: Neoplasms, Uterine Cervix, Metastatic Cervical Cancer
Keywords: pazopanib, ErB1/ErB2, lapatinib, persistent, VEGF, recurrent, metastatic cervical cancer, advanced
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jul 2008 (actual)
Study completion: Jul 2011 (actual)
First posted: 2 Feb 2007 (estimated)
Results: Posted 14 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone or pazopanib alone in subjects with metastatic cervical cancer

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Combination arm	Experimental	Drug: lapatinib (GW572016)Pazopanib plus lapatinib
Lapatinib monotherapy	Active comparator	Drug: lapatinib (GW572016)Lapatinib
Pazopanib monotherapy	Active comparator	Drug: pazopanib (GW786034)Pazopanib

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (36 listed)

A subject will be eligible for inclusion in this study only if all of the following criteria are met:
Signed, written informed consent prior to performing any study-related procedures
Female subjects ≥18 years of age
FIGO Stage IVB, or recurrent or persistent cervical cancer
Life expectancy of at least 12 weeks

Key exclusion criteria (30 listed)

A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Neuroendocrine or small cell carcinoma of the cervix.
Prior use of any biologic therapy with VEGF, VEGFR, or ErbB1/ErbB2 inhibitors.
Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization).
Concurrent treatment with an investigational agent or participation in another clinical trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pazopanib (GW786034)	Drug	Pazopanib monotherapy
lapatinib (GW572016)	Drug	Combination arm, Lapatinib monotherapy

Primary outcome

Progression-free Survival (PFS) in Interim Analysis
Time frame: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. The study was designed to test Combination vs. Lapatinib first. The result indicated that Combination would not show improvement over Lapatinib even if followed until the final analysis and the Combination arm was terminated. The monotherapy arms continued to the final analysis. Data shown here are from this interim analysis.
Progression-free Survival (PFS) in Final Analysis
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
PFS is defined as the interval between the date of randomization and the date of disease progression or death due to any cause. This study began as a 3-arm study. The combination arm was terminated at the interim analysis. The monotherapy arms continued to final analysis. Data shown here are from the final analysis.

6 secondary outcomes

Overall Survival
Time frame: From Randomization (11 December 2006) until approximately 78% overall survival events at the time of the second overall survival update (3 March 2010) (up to 168.29 weeks)
Clinical Benefit Response
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Response
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Time to Response
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Duration of Response
Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks)
Safety and Tolerability of Pazopanib, Lapatinib and the Combination of Pazopanib and Lapatinib
Time frame: From Randomization (11 December 2006) until last participant had last visit (28 July 2011) in combined population of two monotherapy arms (up to 241.43 weeks)

Results and safety

Results posted to the registry on 14 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg	59	0
Lapatinib Monotherapy	58	0
Pazopanib Monotherapy	60	0

Primary outcome: Progression-free Survival (PFS) in Interim Analysis

Time frame: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks). Median (90% Confidence Interval). Unit: Weeks

Measure	Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg n = 59	Lapatinib Monotherapy n = 58	Pazopanib Monotherapy n = 60
Value	12.6 (11.7 to 14.1)	12.6 (11.6 to 18.3)	17.9 (12.1 to 23.9)

Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg vs Lapatinib Monotherapy: Hazard Ratio (HR): 1.05 (90% CI 0.65 to 1.7), p = 0.535, Log Rank

Population analysed: Intent to Treat (ITT) Population: all randomized participants

Primary outcome: Progression-free Survival (PFS) in Final Analysis

Time frame: From Randomization until 105 total PFS events in combined population of two monotherapy arms (up to 85.57 weeks). Median (90% Confidence Interval). Unit: Weeks

Measure	Lapatinib Monotherapy n = 78	Pazopanib Monotherapy n = 74
Value	17.1 (12.1 to 18.1)	18.1 (15.1 to 24.6)

Lapatinib Monotherapy vs Pazopanib Monotherapy: Hazard Ratio, log: 0.66 (90% CI 0.48 to 0.91), p = 0.013, Log Rank

Population analysed: ITT Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs/AEs were assessed in par. receiving >=1 dose of study treatment at time of final PFS analysis (From Randomization [11 December 2006] until last par. had last visit [28 July 2011] in combined population of two monotherapy arms [up to 241.43 weeks]). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg	32 of 76 (42.1%)	71 of 76 (93.4%)	Not reported
Lapatinib Monotherapy	22 of 76 (28.9%)	66 of 76 (86.8%)	Not reported
Pazopanib Monotherapy	28 of 74 (37.8%)	69 of 74 (93.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20606083Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN. Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2010 Aug 1;28(22):3562-9. doi: 10.1200/JCO.2009.26.9571. Epub 2010 Jul 6.
Results publication: PubMed 22084371Monk BJ, Pandite LN. Survival data from a phase II, open-label study of pazopanib or lapatinib monotherapy in patients with advanced and recurrent cervical cancer. J Clin Oncol. 2011 Dec 20;29(36):4845. doi: 10.1200/JCO.2011.38.8777. Epub 2011 Nov 14. No abstract available.
Derived from this study: PubMed 23054212de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

63 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pazopanib (GW786034) and lapatinib (GW572016) in people with Neoplasms, Uterine Cervix and Metastatic Cervical Cancer, run by GlaxoSmithKline at 63 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Argentina, France, Germany, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) in Interim Analysis (time frame: From randomization until at least 35 PFS events in pairwise comparison of the three treatment arms (Interim Analysis; up to 52.14 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430781, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.