Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Neoplasm Metastasis

Carcinoma

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Breast Diseases

Skin Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

PF-06263507

Antineoplastic Agents, Immunological

Antimitotic Agents

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.

Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

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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.

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

A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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.

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 NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.

Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.

Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.

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).

The number of participants with positive anti-PF-06263507 antibody.

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.

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 was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.

Pfizer

PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 0.05 mg/kg

PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 0.1 mg/kg

PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 0.19 mg/kg

PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 0.37 mg/kg

PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 0.73 mg/kg

PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 1.42 mg/kg

PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 2.78 mg/kg

PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 4.34 mg/kg

PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 5.42 mg/kg

PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.

PF-06263507 6.5 mg/kg

Total

Age, Continuous

Sex: Female, Male

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

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All enrolled participants who received at least one dose of study medication.

Number of Participants With Dose-limiting Toxicities (DLT)

Any AEs, Grade 1

Any AEs, Grade 2

Any AEs, Grade 3

Any AEs, Grade 4

Any AEs, Grade 5

Any AEs, Total

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

Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade

Anemia Grade 1

Anemia Grade 2

Hemoglobin increased Grade 1

Lymphopenia Grade 1

Lymphopenia Grade 2

Lymphopenia Grade 3

Lymphopenia Grade 4

Platelets Grade 1

Platelets Grade 2

Platelets Grade 3

White blood cells (WBC) Grade 1

Number of Participants With Hematological Test Abnormalities in All Cycles.

Alanine aminotransferase (ALT) Grade 1

Alkaline phosphatase Grade 1

Alkaline phosphatase Grade 2

Alkaline phosphatase Grade 3

Aspartate aminotransferase (AST) Grade 1

AST Grade 2

AST Grade 3

Bilirubin (total) Grade 1

Bilirubin (total) Grade 2

Creatinine Grade 1

Creatinine Grade 2

Hypercalcemia Grade 1

Hypercalcemia Grade 4

Hyperglycemia Grade 1

Hyperglycemia Grade 2

Hyperkalemia Grade 1

Hypernatremia Grade 1

Hypoalbuminemia Grade 1

Hypoalbuminemia Grade 2

Hypocalcemia Grade 1

Hypocalcemia Grade 2

Hypoglycemia Grade 1

Hypokalemia Grade 1

Hypokalemia Grade 3

Hypomagnesemia Grade 1

Hyponatremia Grade 1

Hyponatremia Grade 3

Hypophosphatemia Grade 2

Hypophosphatemia Grade3

Number of Participants With Chemistry Test Abnormalities in All Cycles.

Urine protein Grade 1

Urine protein Grade 2

Number of Participants With Abnormalities in Urine Protein in All Cycles.

DBP <50 mm Hg

SBP maximum increase from baseline >=30 mm Hg

DBP maximum increase from baseline >=20 mm Hg

SBP maximum decrease from baseline >=30 mm Hg

DBP maximum decrease from baseline >=20 mm Hg

Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria

Number of Participants With Positive Anti-PF-06263507 Antibody

Stable/No response

Objective progression

Symptomatic deterioration

Early death

Interminate

Participants who had received at least one dose of study medication and had a baseline tumor assessment

Number of Participants With Best Overall Response (BOR)

Objective Response

Number of deaths

Number for censored

Overall Survival

All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.

Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)

Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)

Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)

Overall Study

Spots Global Cancer Trial Database for A Study Of PF-06263507 In Patients With Advanced Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial