NCT00678977

A Phase I, Open-label, Study of Pazopanib in Combination With Gemcitabine and Gemcitabine Plus Cisplatin for Advanced Solid Tumors

Completed Phase 1 Last updated 14 November 2017

What this trial tests

Phase 1 trial testing Pazopanib (GW786034) in Lung Cancer, Non-Small Cell in 22 participants. Completed in 30 June 2011.

Timeline

3 April 2008

Primary endpoint
30 March 2010

30 June 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	3 April 2008
Primary completion	30 March 2010
Estimated completion	30 June 2011
Sites	2 locations across United Kingdom, Germany

Drugs / interventions tested

• Pazopanib (GW786034) — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Lung Cancer, Non-Small Cell — all drugs for Lung Cancer, Non-Small Cell →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Lung Cancer, Non-Small Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, two-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen(OTR) of pazopanib in combination with gemcitabine (Arm A) or pazopanib, gemcitabine, and cisplatin (Arm B) in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and gemcitabine or pazopanib, gemcitabine and cisplatin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Six to twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Phase I study of pazopanib in combination with gemcitabine in patients with advanced solid tumors.
   Plummer R, Madi A, Jeffels M, Richly H, et al · · 2013 · cited 22× · PMID 23064954 · DOI 10.1007/s00280-012-1982-z