Clinical trial NCT02122146: A Study Of PF-06664178 In Patients With Advanced Solid Tumors
Official title: A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: ADC
PF-06664178
solid tumors
tumors
neoplasm metastasis
NSCLC
non small cell lung cancer
OVCA
ovarian cancer
Phase 1
breast cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-24
Enrollment: 31
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-06664178 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 whom no standard therapy is available
* Performance Status of 0 or 1
* Adequate bone marrow, kidney and liver function
* Part 2 includes target expressing NSCLC, ovarian or breast cancer patients

Exclusion Criteria:

* Brain metastases requiring steroids
* Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
* Active and clinically significant bacterial, fungal, or viral infection

Primary outcomes:
measure: First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
timeFrame: Day 1 up to Day 21
measure: Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]
timeFrame: Day 1 up to Day 21
measure: Number of Participants With Laboratory Abnormalities [Part 2 & 3]
timeFrame: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
Secondary outcomes:
measure: Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]
timeFrame: From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)
measure: Number of Participants With Laboratory Abnormalities[Part 1]
timeFrame: Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)
measure: Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]
timeFrame: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
measure: Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3]
timeFrame: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment
measure: Overall Number of Participants With Objective Tumor Response[Part 1]
timeFrame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
measure: Overall Number of Participants With Objective Tumor Response [Part 2 & 3]
timeFrame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months
measure: Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Trop-2 Expression Levels on Archived Tissue [Part 2 & 3]
timeFrame: Day 1
measure: Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
measure: Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]
timeFrame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC&USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver CTO (CTRC)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: