A Study Of PF-06263507 In Patients With Advanced Solid Tumors

NCT01891669 — Phase 1, Terminated, 26 participants, Pfizer
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A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS

RegistryNCT01891669
StatusTerminated - The study was terminated on June 23, 2015 due to the company's change in prioritization for the portfolio and is not due to any safety concerns.
PhasePhase 1
Study typeInterventional; masking: none, treatment
Enrollment26 (Actual)
SponsorPfizer (Industry)
ConditionsNeoplasms, Carcinoma, Non Small Cell Lung, Breast Neoplasms, Ovarian Neoplasms
InterventionsPF-06263507 (Drug)
Datesstart 2013-08-08, primary completion 2015-06-29, completion 2015-06-29, first posted 2013-07-03, last updated 2019-01-09
Locations4 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Neoplasms All trials for Carcinoma, Non Small Cell Lung All trials of PF-06263507

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Part 1ExperimentalDrug: PF-06263507
  • PF-06263507 (Drug): Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.
  • PF-06263507 (Drug): Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

+Outcome measures

Primary outcomes

  • Number of Participants With Dose-limiting Toxicities (DLT) [Baseline up to Cycle 2 Day 1 (22 days)]: DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Secondary outcomes

  • 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 [Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.]: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
  • Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade [Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.]: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
  • Number of Participants With Hematological Test Abnormalities in All Cycles. [Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment]: Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.
  • Number of Participants With Chemistry Test Abnormalities in All Cycles. [Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment]: Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.
  • Number of Participants With Abnormalities in Urine Protein in All Cycles. [Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment]: Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.
  • Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria [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.]: Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).
  • Number of Participants With Positive Anti-PF-06263507 Antibody [Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication]: The number of participants with positive anti-PF-06263507 antibody.
  • Number of Participants With Best Overall Response (BOR) [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.]: Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
  • Objective Response [Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.]: Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.
  • Overall Survival [Baseline to death]: Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.
  • Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) [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.]
  • Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) [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.]
  • Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) [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.]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Posted results

Participant flow

MilestonePF-06263507 0.05 mg/kgPF-06263507 0.1 mg/kgPF-06263507 0.19 mg/kgPF-06263507 0.37 mg/kgPF-06263507 0.73 mg/kgPF-06263507 1.42 mg/kgPF-06263507 2.78 mg/kgPF-06263507 4.34 mg/kgPF-06263507 5.42 mg/kgPF-06263507 6.5 mg/kg
Started2222222633
Completed0122221221
Not completed2100001412

Outcome results

  • Number of Participants With Dose-limiting Toxicities (DLT) (Primary), Number, Participants: PF-06263507 0.05 mg/kg 0; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 0; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 1; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 2
  • 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 (Secondary), Number, participants: PF-06263507 0.05 mg/kg 1; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 1; PF-06263507 0.37 mg/kg 2; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 2; PF-06263507 2.78 mg/kg 1; PF-06263507 4.34 mg/kg 0; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 0
  • Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade (Secondary), Number, participants: PF-06263507 0.05 mg/kg 1; PF-06263507 0.1 mg/kg 1; PF-06263507 0.19 mg/kg 1; PF-06263507 0.37 mg/kg 2; PF-06263507 0.73 mg/kg 1; PF-06263507 1.42 mg/kg 2; PF-06263507 2.78 mg/kg 2; PF-06263507 4.34 mg/kg 4; PF-06263507 5.42 mg/kg 1; PF-06263507 6.5 mg/kg 0
  • Number of Participants With Hematological Test Abnormalities in All Cycles. (Secondary), Number, Participants: PF-06263507 0.05 mg/kg 1; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 1; PF-06263507 0.37 mg/kg 2; PF-06263507 0.73 mg/kg 1; PF-06263507 1.42 mg/kg 2; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 4; PF-06263507 5.42 mg/kg 1; PF-06263507 6.5 mg/kg 2
  • Number of Participants With Chemistry Test Abnormalities in All Cycles. (Secondary), Number, Participants: PF-06263507 0.05 mg/kg 0; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 2; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 1; PF-06263507 2.78 mg/kg 1; PF-06263507 4.34 mg/kg 1; PF-06263507 5.42 mg/kg 2; PF-06263507 6.5 mg/kg 1
  • Number of Participants With Abnormalities in Urine Protein in All Cycles. (Secondary), Number, Participants: PF-06263507 0.05 mg/kg 1; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 1; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 0; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 0
  • Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria (Secondary), Number, Participants: PF-06263507 0.05 mg/kg 0; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 1; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 1; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 0; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 0
  • Number of Participants With Positive Anti-PF-06263507 Antibody (Secondary), Number, Participants: PF-06263507 0.05 mg/kg 1; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 1; PF-06263507 0.37 mg/kg 1; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 0; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 1
  • Number of Participants With Best Overall Response (BOR) (Secondary), Number, pariticpants: PF-06263507 0.05 mg/kg 0; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 0; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 0; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 0
  • Objective Response (Secondary), Number, pariticpants: PF-06263507 0.05 mg/kg 0; PF-06263507 0.1 mg/kg 0; PF-06263507 0.19 mg/kg 0; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 0; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 0
  • Overall Survival (Secondary), Number, pariticpants: PF-06263507 0.05 mg/kg 0; PF-06263507 0.1 mg/kg 1; PF-06263507 0.19 mg/kg 0; PF-06263507 0.37 mg/kg 0; PF-06263507 0.73 mg/kg 0; PF-06263507 1.42 mg/kg 0; PF-06263507 2.78 mg/kg 0; PF-06263507 4.34 mg/kg 1; PF-06263507 5.42 mg/kg 0; PF-06263507 6.5 mg/kg 1
  • Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) (Secondary), Median, hour: PF-06263507 0.05 mg/kg 1.07 (1.03 to 1.10); PF-06263507 0.1 mg/kg 1.00 (1.00 to 1.00); PF-06263507 0.19 mg/kg 2.49 (0.983 to 4.00); PF-06263507 0.37 mg/kg 1.01 (1.00 to 1.02); PF-06263507 0.73 mg/kg 1.03 (1.02 to 1.03); PF-06263507 1.42 mg/kg 1.02 (1.00 to 1.03); PF-06263507 2.78 mg/kg 2.49 (1.00 to 3.98); PF-06263507 4.34 mg/kg 1.13 (0.983 to 11.0); PF-06263507 5.42 mg/kg 1.03 (1.00 to 1.03); PF-06263507 6.5 mg/kg 1.22 (1.17 to 7.93)
  • Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) (Secondary), Median, hour: PF-06263507 0.05 mg/kg 1.07 (1.03 to 1.10); PF-06263507 0.1 mg/kg 4.00 (4.00 to 4.00); PF-06263507 0.19 mg/kg 2.53 (1.05 to 4.00); PF-06263507 0.37 mg/kg 1.01 (1.00 to 1.02); PF-06263507 0.73 mg/kg 6.01 (1.02 to 11.0); PF-06263507 1.42 mg/kg 1.02 (1.00 to 1.03); PF-06263507 2.78 mg/kg 7.44 (3.98 to 10.9); PF-06263507 4.34 mg/kg 4.00 (1.07 to 8.08); PF-06263507 5.42 mg/kg 8.00 (1.03 to 8.05); PF-06263507 6.5 mg/kg 3.90 (1.17 to 4.02)
  • Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) (Secondary), Median, hour: PF-06263507 0.1 mg/kg 36.2 (24.4 to 48.0); PF-06263507 0.19 mg/kg 16.0 (8.00 to 24.0); PF-06263507 0.37 mg/kg 37.2 (26.3 to 48.0); PF-06263507 0.73 mg/kg 51.0 (4.00 to 98.0); PF-06263507 1.42 mg/kg 9.99 (7.98 to 12.0); PF-06263507 2.78 mg/kg 9.51 (8.12 to 10.9); PF-06263507 4.34 mg/kg 8.02 (7.30 to 12.0); PF-06263507 5.42 mg/kg 8.13 (8.05 to 70.8); PF-06263507 6.5 mg/kg 8.25 (7.93 to 8.28)

Adverse events

Time frame: Baseline to end of treatment/withdrawal

ArmDeathsSerious adverse eventsOther adverse events
PF-06263507 0.05 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 0.1 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 0.19 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 0.37 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 0.73 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 1.42 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 2.78 mg/kg00/2 (0.0%)2/2 (100.0%)
PF-06263507 4.34 mg/kg01/6 (16.7%)6/6 (100.0%)
PF-06263507 5.42 mg/kg00/3 (0.0%)3/3 (100.0%)
PF-06263507 6.5 mg/kg00/3 (0.0%)3/3 (100.0%)

Serious adverse events by term

TermOrgan systemPF-06263507 0.05 mg/kgPF-06263507 0.1 mg/kgPF-06263507 0.19 mg/kgPF-06263507 0.37 mg/kgPF-06263507 0.73 mg/kgPF-06263507 1.42 mg/kgPF-06263507 2.78 mg/kgPF-06263507 4.34 mg/kgPF-06263507 5.42 mg/kgPF-06263507 6.5 mg/kg
Atrial fibrillationCardiac disorders0/20/20/20/20/20/20/21/60/30/3
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/20/20/20/20/20/20/21/60/30/3

Other adverse events by term

TermOrgan systemPF-06263507 0.05 mg/kgPF-06263507 0.1 mg/kgPF-06263507 0.19 mg/kgPF-06263507 0.37 mg/kgPF-06263507 0.73 mg/kgPF-06263507 1.42 mg/kgPF-06263507 2.78 mg/kgPF-06263507 4.34 mg/kgPF-06263507 5.42 mg/kgPF-06263507 6.5 mg/kg
AnaemiaBlood and lymphatic system disorders0/20/20/20/20/21/20/20/61/31/3
CoagulopathyBlood and lymphatic system disorders0/20/20/20/20/20/20/20/61/30/3
LeukopeniaBlood and lymphatic system disorders0/20/20/20/20/20/20/21/60/30/3
LymphadenopathyBlood and lymphatic system disorders1/20/20/20/20/20/20/20/60/30/3
ThrombocytopeniaBlood and lymphatic system disorders0/20/20/20/20/20/20/22/61/33/3
TachycardiaCardiac disorders1/21/20/20/20/20/20/20/61/30/3
Corneal depositsEye disorders0/20/20/20/20/20/20/20/60/31/3
Dry eyeEye disorders0/20/20/20/20/20/21/21/62/32/3
Eye painEye disorders0/20/20/20/20/20/20/21/62/31/3
Eye pruritusEye disorders0/20/20/20/20/20/20/20/61/30/3
Eye swellingEye disorders0/20/20/20/20/20/20/20/61/30/3
KeratitisEye disorders0/20/20/20/20/20/20/20/60/31/3
KeratopathyEye disorders0/20/20/20/20/20/20/21/60/30/3
Lacrimation decreasedEye disorders0/20/20/20/20/20/20/21/60/30/3
Lacrimation increasedEye disorders0/20/20/20/20/20/20/21/61/30/3
PhotophobiaEye disorders0/20/20/20/20/20/20/23/62/32/3
Vision blurredEye disorders1/20/20/20/20/20/20/22/61/31/3
Vitreous floatersEye disorders0/20/20/20/20/20/20/21/60/31/3
Abdominal distensionGastrointestinal disorders1/21/21/20/20/20/20/20/61/32/3
Abdominal painGastrointestinal disorders1/20/20/20/20/20/20/20/60/30/3
Abdominal pain upperGastrointestinal disorders0/20/20/21/20/20/20/21/60/30/3
AscitesGastrointestinal disorders0/20/20/20/20/20/20/21/61/31/3
ConstipationGastrointestinal disorders0/20/20/21/20/20/21/21/61/30/3
DiarrhoeaGastrointestinal disorders1/20/20/20/20/20/20/20/61/31/3
Dry mouthGastrointestinal disorders0/20/20/20/21/20/21/21/60/31/3
DyspepsiaGastrointestinal disorders0/20/20/21/21/20/20/20/60/30/3
Mouth ulcerationGastrointestinal disorders0/20/20/20/20/20/20/20/60/31/3
NauseaGastrointestinal disorders0/21/20/21/20/20/22/23/60/31/3
Oral mucosal erythemaGastrointestinal disorders0/20/20/20/20/20/21/20/60/30/3
RetchingGastrointestinal disorders0/20/20/20/20/21/20/20/60/30/3
StomatitisGastrointestinal disorders0/20/20/20/20/20/21/20/60/30/3
VomitingGastrointestinal disorders1/20/21/21/21/21/21/21/60/31/3
Application site irritationGeneral disorders0/20/20/20/20/20/20/20/60/31/3
Chest discomfortGeneral disorders0/20/21/20/20/20/20/20/60/30/3
Chest painGeneral disorders0/20/20/20/20/20/20/20/61/30/3
ChillsGeneral disorders0/21/20/20/20/20/20/20/62/31/3
FatigueGeneral disorders0/21/20/21/21/21/21/24/62/31/3
InflammationGeneral disorders0/20/20/20/20/20/20/21/60/30/3
Non-cardiac chest painGeneral disorders0/20/20/20/21/20/21/20/60/30/3
OedemaGeneral disorders0/20/20/20/20/20/20/21/60/30/3
Oedema peripheralGeneral disorders1/20/21/20/20/20/20/21/61/31/3
Peripheral swellingGeneral disorders1/20/20/20/20/20/20/20/60/30/3
PyrexiaGeneral disorders0/20/20/20/20/20/20/21/61/30/3
Hepatobiliary diseaseHepatobiliary disorders0/20/20/20/20/20/20/20/60/31/3
ConjunctivitisInfections and infestations0/20/20/20/20/20/20/21/60/31/3
Device related infectionInfections and infestations0/21/20/20/20/20/20/21/60/30/3
Fungal skin infectionInfections and infestations0/20/20/20/20/20/21/20/60/30/3
Oral infectionInfections and infestations0/20/20/20/20/20/20/20/60/31/3
SinusitisInfections and infestations0/20/20/20/20/20/20/20/61/30/3
Upper respiratory tract infectionInfections and infestations0/20/21/20/20/20/20/21/60/30/3
Urinary tract infectionInfections and infestations0/21/21/20/20/20/20/20/60/30/3
FallInjury, poisoning and procedural complications2/20/20/20/20/20/20/20/60/30/3
Alanine aminotransferase increasedInvestigations0/20/20/20/20/20/20/20/61/31/3
Aspartate aminotransferase increasedInvestigations1/20/21/20/20/20/20/20/62/32/3
Blood alkaline phosphatase increasedInvestigations1/20/21/20/20/20/20/20/61/30/3
Blood bilirubin increasedInvestigations0/20/20/20/20/20/20/20/61/30/3
Blood creatinine increasedInvestigations1/20/20/20/20/20/20/22/60/30/3
Blood lactate dehydrogenase increasedInvestigations0/20/20/20/20/20/20/20/60/31/3
Blood urea increasedInvestigations1/20/20/20/20/21/20/20/60/30/3
Cardiac murmurInvestigations0/20/20/20/20/20/20/20/61/30/3

59 more terms not shown.

Limitations and caveats: This study was terminated prematurely before treatment in Part 2 started due to a business-related decision.

+Locations (4)

FacilityCityCountryStatus
Brigham and Women's HospitalBoston, MassachusettsUnited States
Dana-Farber Cancer InstituteBoston, MassachusettsUnited States
Karmanos Cancer InstituteDetroit, MichiganUnited States
Fox Chase Cancer CenterPhiladelphia, PennsylvaniaUnited States

+Publications

  • Results publication: 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. PMID 28070718

+Investigators

  • Pfizer CT.gov Call Center, Study director, Pfizer