Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Sunitinib

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Folinic Acid

Folate

Vitamin B9

Sunitinib daily by oral capsule in a continuous daily dosing regimen with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Sunitinib, Pemetrexed

Sunitinib daily by oral capsule administered for 2 weeks out of every 3 weeks with pemetrexed every 3 weeks until progression or unacceptable toxicity.

Pfizer CT.gov Call Center

This study will assess if the combination of sunitinib and pemetrexed is tolerable when coadministered at each recommended dose/schedule.

A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

Phase 1 Study Of Sunitinib (SU011248) In Combination With Pemetrexed In Patients With Advanced Solid Malignancies In Japan

Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.

Relative dose intensity was defined as percentage of total dose administered over total planned dose in the given period.

Trough concentration was defined as observed concentration at 24 hours post dose. SU012662 is an active metabolite of sunitinib.

AUC0-24 = Area under the plasma concentration versus time curve to 24 hours post dose was calculated using the linear/logarithmic trapezoidal method. SU012662 is an active metabolite of sunitinib.

Tmax = Time to maximum plasma concentration. SU012662 is an active metabolite of sunitinib.

AUC0-∞ = Area under the plasma concentration versus time curve from zero time to infinity was calculated as the sum of AUClast and (Ct\*/kel), where Ct\* was the estimated concentration at the time of the last quantifiable concentration, kel was terminal phase rate constant that is estimated as the absolute value of the slope of a linear regression during the terminal phase of the natural-logarithm (ln) transformed concentration-time profile.

Terminal phase elimination half-life was calculated as "natural logarithm of 2 (ln2) divided by the rate constant for terminal phase (kel)".

Complete response (CR): disappearance of all target lesions; Partial response (PR): \>=30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD; Progressive disease (PD): \>=20% increase in the SLD of the target lesions taking as a reference the smallest SLD recorded since the treatment started, or the appearance of \>=1 new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as a reference the smallest SLD since the treatment started.

Pfizer

Director, Clinical Trial Disclosure Group

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Sunitinib 37.5 mg was administered continuously on a daily basis. Pemetrexed 500 mg/m\^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Sunitinib 37.5 mg/Day Continuous Daily Dosing

Sunitinib 50.0 mg was administered continuously on a daily basis for 2 weeks, followed by 1 week off treatment.

Pemetrexed 500 mg/m\^2 was administered as intravenous infusion over 10 minutes on the first day (Day 1) of each 21-day cycle.

Sunitinib 50 mg/Day Schedule-2/1

Total

20-44 years

45- 64 years

>=65 years

Age, Customized

Sex: Female, Male

Score 0

Score 1

Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light house work and office work.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Pfizer ClinicalTrials.gov Call Center

Any adverse events

Any dose limiting toxicities

Any serious adverse events

Any Grade-3 or -4 adverse events

Any Grade-5 adverse events (= death)

Discontinuation due to adverse events

All subjects who received at least 1 dose of the study drug.

Number of Participants With Adverse Events

Cycle 1 (n=6)

Cycle 2 (n=6)

Cycle 3 (n=4)

Cycle 4 (n=4)

Cycle 5 (n=1)

Full analysis set = defined as "all enrolled patients". n = number of participants assessed for the relative dose intensity in the given period.

Sunitinib Relative Dose Intensity in the "Sunitinib 37.5 mg/Day Continuous Daily Dosing" Treatment Arm

Cycle 2 (n=5)

Cycle 4 (n=3)

Cycle 5 (n=3)

Cycle 6 (n=3)

Sunitinib Relative Dose Intensity in the "Sunitinib 50 mg/Day Schedule-2/1" Treatment Arm

Sunitinib: Trough concentration

Sunitinib: Maximum concentration

SU012662: Trough concentration

SU012662: Maximum concentration

Total drug: Trough concentration

Total drug: Maximum concentration

Participants who provided a plasma concentration data was included in the analysis.

Trough and Maximum Concentration of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

SU012662

Total Drug

AUC 0-24 of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

Tmax of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

Maximum Concentration of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

AUC0-∞ of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

Terminal Phase Elimination Half-Life (T1/2) of Pemetrexed Following Continuous Daily Dosing of Sunitinib 37.5 mg/Day in Combination With Pemetrexed 500 mg/m^2 at Cycle 2 Day 1

Participants who provided a plasma concentration data was included in the analysis

Trough Concentrations of Sunitinib, SU012662, and Total Drug (Sunitinib + SU012662) After Coadministration of Sunitinib 50 mg/Day and Pemetrexed 500 mg/m^2 (Cycle 1 Day 1), Followed by Sunitinib 50 mg/Day on Schedule-2/1 at Cycle 1 Day 14 or 15

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

Not Evaluable (NE)

Objective Response (CR+PR)

Stable Disease (SD) >=184 days

Clinical Benefit (CR+PR+SD >=184 days)

Evaluable subjects = defined as all subjects who met all the following 3 requirements: 1) met the eligibility (inclusion and exclusion) criteria, 2) received at least 1 dose of the study drug, and 3) assessed appropriately at the baseline and had a measurable lesion based on the RECIST.

Spots Global Cancer Trial Database for A Safety Study Of Sunitinib In Combination With Pemetrexed In Patients With Advanced Solid Malignancies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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