NCT01469052 — First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors · CancerIndex

Clinical trial · Interventional

First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

Phase I, Open-Label, Multicenter, Dose-Escalation Study Of The Tyrosine Kinase Inhibitor Of VEGFR-2, AG013736, In Patients With Advanced Solid Tumors

NCT01469052CI-TRIAL-00006587completedPhase 1Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
AG-013736	Drug	Axitinib	ALIAS

Design

Arms and outcomes

Arms (6)

type
EXPERIMENTAL
label
Cohort 1
interventionNames
1. Drug: AG-013736
type
EXPERIMENTAL
label
Cohort 2
interventionNames
1. Drug: AG-013736
type
EXPERIMENTAL
label
Cohort 3
interventionNames
1. Drug: AG-013736
type
EXPERIMENTAL
label
Cohort 4

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients with cytologically or histologically confirmed solid tumor(s) and with at least one measurable disease site
* Patients with adequate bone marrow, liver and kidney function
* Patients with life expectancy of at least 12 weeks

Exclusion Criteria:

* Patients who have received chemotherapy, immunotherapy, radiotherapy or any investigational agent within 4 weeks of study entry
* Patients with have had a major surgical procedure within 4 weeks of study entry

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 2002
Primary completion: Jul 1, 2004
Completion: Aug 1, 2004
First posted: Nov 10, 2011
Last update posted: Mar 26, 2012
Results first posted: Mar 26, 2012
Enrollment: 36 (actual)
Lead sponsor: Pfizer INDUSTRY

Data updated 22 days agoSource updated Mar 26, 2012source: clinicaltrials

Locations

Locations by country (3)

Country	Sites	Recruiting
United States	3	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.

Primary outcomes (1)

measure
Maximum Tolerated Dose (MTD)
timeFrame
Baseline up to Day 28
description
MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.

Secondary outcomes (10)

measure
Maximum Observed Plasma Concentration (Cmax)
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure
Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
measure
Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
description
AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12).
measure
Apparent Oral Clearance (CL/F)
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
description
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure
Plasma Decay Half-Life (t1/2)
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)
description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure
Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
measure
Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
measure
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
description
AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
measure
Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
description
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure
Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting
timeFrame
Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)
description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.