Clinical trial NCT01891669: A Study Of PF-06263507 In Patients With Advanced Solid Tumors
Official title: A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Carcinoma, Non Small Cell Lung
Breast Neoplasms
Ovarian Neoplasms
Keywords: ADC 5T4
PF-06263507
solid tumors
lung cancer
breast cancer
ovarian cancer
cancer
tumors
neoplasm metastasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.
* Performance Status of 0 or 1.
* Adequate bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

* Brain metastases requiring steroids.
* Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
* Active bacterial, fungal or viral infection.

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Baseline up to Cycle 2 Day 1 (22 days)
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
timeFrame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
measure: Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
timeFrame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
measure: Number of Participants With Hematological Test Abnormalities in All Cycles.
timeFrame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
measure: Number of Participants With Chemistry Test Abnormalities in All Cycles.
timeFrame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
measure: Number of Participants With Abnormalities in Urine Protein in All Cycles.
timeFrame: Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment
measure: Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
timeFrame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.
measure: Number of Participants With Positive Anti-PF-06263507 Antibody
timeFrame: Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication
measure: Number of Participants With Best Overall Response (BOR)
timeFrame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
measure: Objective Response
timeFrame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
measure: Overall Survival
timeFrame: Baseline to death
measure: Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
timeFrame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
measure: Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
timeFrame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
measure: Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
timeFrame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Shapiro GI, Vaishampayan UN, LoRusso P, Barton J, Hua S, Reich SD, Shazer R, Taylor CT, Xuan D, Borghaei H. First-in-human trial of an anti-5T4 antibody-monomethylauristatin conjugate, PF-06263507, in patients with advanced solid tumors. Invest New Drugs. 2017 Jun;35(3):315-323. doi: 10.1007/s10637-016-0419-7. Epub 2017 Jan 9.