Clinical trial NCT02038777: A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies
Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF PF-04449913 (GLASDEGIB), AN ORAL HEDGEHOG INHIBITOR, ADMINISTERED AS A SINGLE AGENT IN JAPANESE PATIENTS WITH SELECT HEMATOLOGIC MALIGNANCIES AND IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW-DOSE ARA-C, OR AZACITIDINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Hematologic Malignancies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: MTD was determined in monotherapy cohort. Then two combination cohorts (Combination Cohorts 1 and 2) were added to evaluate the safety of glasdegib administered with chemotherapies. Another combination cohort (Combination Cohort 3) was added to evaluate the safety of glasdegib administered with Azacitidine. Then, Continuation Cohort which allows one Japanese patient enrolled from another trial in the same project was added. Afther that, Expansion Cohort of LDAC Combination for efficacy was added.
Primary purpose: TREATMENT

Brief summary: This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients. PF-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with LDAC \[Low-Dose Ara-C\] or cytarabine and daunorubicin in previously untreated patients with AML \[Acute Myeloid Leukemia\] or high-risk MDS \[Myelodysplastic Syndrome\], or in combination with azacitidine in previously untreated patients with AML.


Eligibility criteria: Inclusion Criteria:

* Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies for monotherapy cohort.
* Patients with AML or High-Risk MDS who are newly diagnosed and previously untreated for combination cohort.
* Patients with AML who are newly diagnosed and previously untreated for azacitidine combination cohort.
* ECOG \[Eastern Cooperative Oncology Group\] performance status 0 to 2
* Adequate organ function

Exclusion Criteria:

* Patients with active CNS disease
* Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical
* Patient has an active, life threatening or clinically significant uncontrolled systemic infection

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy Cohort
timeFrame: Day -5 up to Day 28 of Cycle 1 (33 days)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Treatment Related TEAEs, Grade 3 or 4 TEAEs Based on NCI CTCAE v4.0: Monotherapy Cohort
timeFrame: Day 1 up to 28 days after last dose of study drug (For 25 mg: maximum up to 136 days; For 50 mg: maximum up to 179 days; For 100 mg: maximum up to 472 days)
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Abnormalities: Monotherapy Cohort
timeFrame: For 25 mg: Baseline up to maximum 108 days; For 50 mg: Baseline up to maximum 151 days; For 100 mg: Baseline up to maximum 444 days
measure: Number of Participants With Worst On-study Laboratory Abnormalities: Monotherapy Cohort
timeFrame: For 25 mg: Baseline up to maximum 136 days; For 50 mg: Baseline up to maximum 179 days; For 100 mg: Baseline up to maximum 472 days
measure: Number of Participants With DLTs: Combination Cohort 1
timeFrame: Day 1 up to Day 28 of Cycle 1 (28 days)
measure: Number of Participants With TEAEs, Serious TEAEs, Treatment Related TEAEs, Grade 3 or 4 TEAEs Based on NCI CTCAE v4.0: Combination Cohort 1
timeFrame: Day 1 up to 28 days after last dose of study drug (maximum up to 514 days)
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Abnormalities: Combination Cohort 1
timeFrame: Baseline up to maximum 486 days
measure: Number of Participants With Worst On-study Laboratory Abnormalities: Combination Cohort 1
timeFrame: Baseline up to maximum 514 days
measure: Number of Participants With DLTs: Combination Cohort 2
timeFrame: Day -3 up to anytime between Day 21 and Day 28 of first induction cycle (24 to 31 days)
measure: Number of Participants With TEAEs, Serious TEAEs, Treatment Related TEAEs, Grade 3 or 4 TEAEs Based on NCI CTCAE v4.0: Combination Cohort 2
timeFrame: Day 1 up to 28 days after last dose of study drug (maximum up to 371 days)
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Abnormalities: Combination Cohort 2
timeFrame: Baseline up to maximum 343 days
measure: Number of Participants With Worst On-study Laboratory Abnormalities: Combination Cohort 2
timeFrame: Baseline up to maximum 371 days
measure: Percentage of Participants Achieving Disease Modifying Response (DMR): Expansion Cohort
timeFrame: Baseline up to maximum 736 days
measure: Number of Participants With DLTs: Combination Cohort 3
timeFrame: Day 1 up to Day 28 of Cycle 1 (28 days)
measure: Number of Participants With TEAEs, Serious TEAEs, Treatment Related TEAEs, Grade 3 or 4 TEAEs Based on NCI CTCAE v4.0: Combination Cohort 3
timeFrame: Day 1 up to 28 days after last dose of study drug (maximum up to 869 days)
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Abnormalities: Combination Cohort 3
timeFrame: Baseline up to maximum 841 days
measure: Number of Participants With Worst On-study Laboratory Abnormalities: Combination Cohort 3
timeFrame: Baseline up to maximum 869 days
Secondary outcomes:
measure: Single Dose- Maximum Observed Plasma Concentration (Cmax) of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Single Dose- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Single Dose- Terminal Plasma Half-life (T1/2) of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Single Dose- Area Under the Plasma Concentration Curve: From Time Zero to End of Dosing Interval (AUCtau), From Time Zero to Last Quantifiable Concentration (AUClast) and From Time Zero to Infinity (AUCinf) of PF-04449913 for Monotherapy Cohort
timeFrame: AUCtau: 0 to 24, 24 to 48, 48 to 72 hours post PF-04449913 dosing on Day -5 of Cycle 1; AUClast and AUCinf: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Single Dose- Clearance (CL/F) of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Single Dose- Volume of Distribution (Vz/F) of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Multiple Dose Cmax, Minimum Observed Plasma Concentration (Cmin), Average Observed Plasma Concentration (Cavg), Trough Plasma Concentration (Ctrough) of PF-04449913: Monotherapy Cohort
timeFrame: Cmax, Cmin: Pre-dose and 0.5, 1, 2, 4, 8, and 24 hours post PF-04449913 dosing on Day 21 of Cycle 1; Cavg: 0 to 24, 24 to 48, 48 to 72 hours post PF-04449913 dosing on Day 21 of Cycle 1; Ctrough: Pre-dose on Day 21 of Cycle 1
measure: Multiple Dose- Tmax of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, and 24 hours post PF-04449913 dosing on Day 21 of Cycle 1
measure: Multiple Dose- AUCtau of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, and 24 hours post PF-04449913 dosing Day 21 of Cycle 1
measure: Multiple Dose- Clearance (CL/F) of PF-04449913: Monotherapy Cohort
timeFrame: Pre-dose and 0.5, 1, 2, 4, 8, and 24 hours post PF-04449913 dosing Day 21 of Cycle 1
measure: Multiple Dose- Accumulation Ratio (Rac) of PF-04449913: Monotherapy Cohort
timeFrame: 0 to 24, 24 to 48, 48 to 72 hours post PF-04449913 dosing on Day -5 and Day 21 of Cycle 1
measure: Multiple Dose- Steady State Accumulation Ratio (Rss) of PF-04449913: Monotherapy Cohort
timeFrame: AUCtau: 0 to 24, 24 to 48, 48 to 72 hours post PF-04449913 dosing on Day 21 of Cycle 1; AUCinf: Pre-dose and 0.5, 1, 2, 4, 8, 24, 48, 72 hours post PF-04449913 dosing on Day -5 of Cycle 1
measure: Ratio of GLI1 Levels at Baseline to Day 21 Cycle 1: Monotherapy Cohort
timeFrame: Baseline, Day 21 of Cycle 1 (Unspecified- at any time on Day 21)
measure: Number of Participants With Best Response: Monotherapy Cohort
timeFrame: Day 1 up to End of Treatment (25 mg: maximum up to 108 days; 50 mg: maximum up to 151 days; 100 mg: maximum up to 444 days)
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of PF-04449913: Combination Cohort 1
timeFrame: Cmax, Cmin: Pre-dose and 0.5, 1, 2, 4, 6 and 24 hours post PF-04449913 dose on Day 10 and 21 of Cycle 1; Cavg: 0 to 24 hours post PF-04449913 dose on Day 10 and 21 of Cycle; Ctrough: Pre-dose on Day 10 and 21 of Cycle 1
measure: Multiple Dose- Tmax of PF-04449913: Combination Cohort 1
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6 and 24 hours post PF-04449913 dose on Day 10 and Day 21 of Cycle 1
measure: Multiple Dose- AUCtau of PF-04449913: Combination Cohort 1
timeFrame: 0 to 24 hours post PF-04449913 dose on Day 10 and Day 21 of Cycle 1
measure: Multiple Dose- CL/F of PF-04449913: Combination Cohort 1
timeFrame: Pre-dose and 0.5, 1, 2, 4, 6 and 24 hours post PF-04449913 dose on Day 10 and Day 21 of Cycle 1
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of Cytarabine: Combination Cohort 1
timeFrame: Cmax, Cmin: Pre-dose and 0.25, 0.5, 1, 2, 4 and 6 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1; Cavg: 0 to 12 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1; Ctrough: Pre-LDAC dose on Day 2 and Day 10 of Cycle 1
measure: Multiple Dose- Tmax of Cytarabine: Combination Cohort 1
timeFrame: Pre-dose and 0.25, 0.5, 1, 2, 4 and 6 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1
measure: Multiple Dose- T1/2 of Cytarabine: Combination Cohort 1
timeFrame: Pre-dose and 0.25, 0.5, 1, 2, 4 and 6 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1
measure: Multiple Dose- AUCinf and AUCtau of Cytarabine: Combination Cohort 1
timeFrame: AUCinf: Pre-dose and 0.25, 0.5, 1, 2, 4 and 6 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1; AUCtau: 0 to 12 hours post LDAC dosing on Day 2 and Day 10 of Cycle
measure: Multiple Dose- Cmax, Cmin, and Ctrough of Ara-uridine: Combination Cohort 1
timeFrame: Cmax, Cmin: Pre-dose and 0.25, 0.5, 1, 2, 4 and 6 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1; Cavg: 0 to 12 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1; Ctrough: Pre-LDAC dosing on Day 2 and Day 10 of Cycle 1
measure: Multiple Dose- Tmax of Ara-uridine: Combination Cohort 1
timeFrame: Pre-dose and 0.25, 0.5, 1, 2, 4 and 6 hours post LDAC dosing on Day 2 and Day 10 of Cycle 1
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of PF-04449913: Combination Cohort 2
timeFrame: Cmax, Cmin: Pre-dose, 0.5, 1, 6, and 24 hrs post dose on Day 3, 10 of induction Cycle (IC) 1 and 4 hrs post dose on Day 10 of IC 1; Cavg: 0 to 24 hrs post dose on Day 3 and Day 10 of IC 1; Ctrough: Pre dose on Day 3 and Day 10 of IC 1 (PF-04449913 Dose)
measure: Multiple Dose- Tmax of PF-04449913: Combination Cohort 2
timeFrame: Pre-dose, 0.5, 1, 6, and 24 hours post PF-04449913 dosing on Day 3 of Induction Cycle 1 and pre-dose, 0.5, 1, 4, 6, and 24 hours post PF-04449913 dosing on Day 10 of Induction Cycle 1
measure: Multiple Dose- AUCtau of PF-04449913: Combination Cohort 2
timeFrame: Pre-dose, 0.5, 1, 6, and 24 hours post PF-04449913 dosing on Day 3 of induction Cycle 1 and pre-dose, 0.5, 1, 4, 6, and 24 hours post PF-04449913 dosing on Day 10 of induction Cycle 1
measure: Multiple Dose- CL/F of PF-04449913: Combination Cohort 2
timeFrame: Pre-dose, 0.5, 1, 6, and 24 hours post PF-04449913 dosing on Day 3 of induction Cycle 1 and pre-dose, 0.5, 1, 4, 6, and 24 hours post PF-04449913 dosing on Day 10 of induction Cycle 1
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of Daunorubicin: Combination Cohort 2
timeFrame: Cmax, Cmin: Pre-dose, 0.25 (mid-infusion), 0.5 (immediately prior to end of infusion), 1, 4, 6, 24 hours post daunorubicin dosing on Day 3 of induction Cycle (IC) 1; Cavg: 0 to 24 hours post dose on Day 3 of IC 1; Ctrough: Pre-dose on Day 3 of IC 1
measure: Multiple Dose- Tmax of Daunorubicin: Combination Cohort 2
timeFrame: Pre-dose, 0.25 (mid-infusion), 0.5 (immediately prior to end of infusion), 1, 4, 6, 24 hours post daunorubicin dosing on Day 3 of induction Cycle 1
measure: Multiple Dose- T1/2 of Daunorubicin: Combination Cohort 2
timeFrame: Pre-dose, 0.25 (mid-infusion), 0.5 (immediately prior to end of infusion), 1, 4, 6, 24 hours post daunorubicin dosing on Day 3 of at induction Cycle 1
measure: Multiple Dose- AUCinf and AUCtau of Daunorubicin: Combination Cohort 2
timeFrame: AUCinf: Pre-dose, 0.25 (mid-infusion), 0.5 (immediately prior to end of infusion), 1, 4, 6, 24 hours post daunorubicin dosing on Day 3 of induction Cycle 1; AUCtau: 0 to 24 hours post daunorubicin dosing on Day 3 of induction Cycle 1
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of Daunorubicinol: Combination Cohort 2
timeFrame: Cmax, Cmin: Pre-dose, 0.25 (mid-infusion), 0.5 (immediately prior to end of infusion), 1, 4, 6, 24 hours post daunorubicin dosing on Day 3 of induction Cycle (IC) 1; Cavg: 0 to 24 hours post dose on Day 3 of IC 1; Ctrough: Pre-dose on Day 3 of IC 1
measure: Multiple Dose- Tmax of Daunorubicinol: Combination Cohort 2
timeFrame: Pre-dose, 0.25 (mid-infusion), 0.5 (immediately prior to end of infusion), 1, 4, 6, 24 hours post daunorubicin dosing on Day 3 of induction Cycle 1
measure: Multiple Dose- AUCtau of Daunorubicinol: Combination Cohort 2
timeFrame: 0 to 24 hours post daunorubicin dosing on Day 3 of induction Cycle 1
measure: Ratio of GLI1 Levels at Baseline to Day 21 Cycle 1: Combination Cohort 1
timeFrame: Baseline, Day 21 of Cycle 1 (Unspecified- at any time on Day 21)
measure: Ratio of GLI1 Levels at Baseline to Day 21 Cycle1: Combination Cohort 2
timeFrame: Baseline, Day 21 of Cycle 1 (Unspecified- at any time on Day 21)
measure: Number of Participants With Best Response: Combination Cohort 1
timeFrame: Day 1 up to end of treatment (maximum up to 486 days)
measure: Number of Participants With Best Response: Combination Cohort 2
timeFrame: Day 1 up to end of treatment (maximum up to 343 days)
measure: Percentage of Participants With Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi) and DMR: Combination Cohort 1
timeFrame: Day 1 up to end of treatment (maximum up to 486 days)
measure: Duration of Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi) and DMR Response: Combination Cohort 1
timeFrame: Day 1 up to end of treatment (maximum up to 486 days)
measure: Time to Response: Combination Cohort 1
timeFrame: Day 1 up to end of treatment (maximum up to 486 days)
measure: Overall Survival: Combination Cohort 1
timeFrame: First dose of study drug up to death or date of last contact (maximum up to 514 days)
measure: Overall Survival (OS): Expansion Cohort
timeFrame: First dose of study drug up to death or date of last contact (maximum up to 1408 days)
measure: Number of Participants With Best Response: Expansion Cohort
timeFrame: From first dose of study drug up to disease progression (maximum duration of 1408 days)
measure: Percentage of Participants With CR/CRi and DMR: Expansion Cohort
timeFrame: Day 1 up to end of treatment (maximum up to 1408 days)
measure: Duration of Response: Expansion Cohort
timeFrame: Day 1 up to end of treatment (maximum up to 1408 days)
measure: Time to Response: Expansion Cohort
timeFrame: Day 1 up to end of treatment (maximum up to 1408 days)
measure: Ratio of GLI1 Levels at Baseline to Day 21 Cycle 1: Expansion Cohort
timeFrame: Baseline, Day 21 of Cycle 1(Predose)
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of PF-04449913: Combination Cohort 3
timeFrame: Cmax, Cmin: Pre-dose, 0.25, 1, 4, 6, 24 hours post PF-04449913 dosing on Day 7 and Day 21 of Cycle 1; Cavg: 0 to 24 hors post PF-04449913 dosing on Day 7 and Day 21 of Cycle 1; Ctrough: Pre PF-04449913 dosing on Day 7 and Day 21 of Cycle 1
measure: Multiple Dose- Tmax of PF-04449913: Combination Cohort 3
timeFrame: Pre-dose, 0.25, 1, 4, 6, 24 hours post PF-04449913 dosing on Day 7 and Day 21 of Cycle 1
measure: Multiple Dose- AUCtau of PF-04449913: Combination Cohort 3
timeFrame: 0 to 24 hours post PF-04449913 dosing on Day 7 and Day 21 of Cycle 1
measure: Multiple Dose- CL/F of PF-04449913: Combination Cohort 3
timeFrame: Pre-dose, 0.25, 1, 4, 6, 24 hours post PF-04449913 dosing on Day 7 and Day 21 of Cycle 1
measure: Multiple Dose- Cmax, Cmin, Cavg, and Ctrough of Azacitidine: Combination Cohort 3
timeFrame: Cmax: 0.25, 0.5, 1, 2, 6 hrs post azacitidine dose on Day 1/Cycle 1;Cmin: Pre-dose, 0.25, 0.5, 1, 2, 6 hrs post azacitidine dose on Day 7/Cycle 1;Cavg: 0 to 24 hrs post azacitidine dose on Day 7/Cycle 1;Ctrough:Pre azacitidine dose on Day 7/Cycle 1
measure: Multiple Dose- Tmax of Azacitidine: Combination Cohort 3
timeFrame: 0.25, 0.5, 1, 2, and 6 hours post azacitidine dosing on Day 1 of Cycle 1 and pre-dose, 0.25, 0.5, 1, 2, and 6 hours post azacitidine dosing on Day 7 of Cycle 1
measure: Multiple Dose- AUCtau and AUCinf of Azacitidine: Combination Cohort 3
timeFrame: AUCinf: 0.25, 0.5, 1, 2, and 6 hours post azacitidine dosing at Day 1 of Cycle 1 and pre-dose, 0.25, 0.5, 1, 2, and 6 hours post azacitidine dosing at 7 of Cycle 1; AUCtau: 0 to 24 hours post azacitidine dosing on Day 1 and 7 of Cycle 1
measure: Overall Survival: Combination Cohort 3
timeFrame: First dose of study drug up to death or date of last contact (maximum up to 841 days)
measure: Ratio of GLI1 Levels at Baseline to End of Treatment: Combination Cohort 3
timeFrame: Baseline, at the end of treatment (hours unspecified, any day maximum up to 841 days)
measure: Number of Participants With Best Response: Combination Cohort 3
timeFrame: Day 1 up to end of treatment (maximum up to 841 days)
measure: Percentage of Participants With CR/CRi and DMR: Combination Cohort 3
timeFrame: Day 1 up to end of treatment (maximum up to 841 days)
measure: Duration of Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi) and DMR Response: Combination Cohort 3
timeFrame: Day 1 up to end of treatment (maximum up to 841 days)
measure: Time to Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi) and DMR Response: Combination Cohort 3
timeFrame: Day 1 up to end of treatment (maximum up to 841 days)
measure: Number of Participants With Laboratory Test Abnormalities: Continuation Cohort
timeFrame: Baseline up to maximum 1146 days
measure: Number of Participants With TEAEs, Serious TEAEs, Treatment Related TEAEs, Grade 3 or 4 TEAEs Based on NCI CTCAE v4.0: Expansion Cohort
timeFrame: Day 1 up to 28 days after last dose of study drug (Maximum up to 1436 days)
measure: Number of Participants With Clinically Significant Vital Signs: Expansion Cohort
timeFrame: Baseline up to maximum 1436 days
measure: Number of Participants With Clinically Significant Vital Signs: Continuation Cohort
timeFrame: Baseline up to maximum 1146 days
measure: Number of Participants With TEAEs, Serious TEAEs, Treatment Related TEAEs, Grade 3 or 4 TEAEs Based on NCI CTCAE v4.0: Continuation Cohort
timeFrame: Day 1 up to 28 days after last dose of study drug (Maximum up to 1146 days)
measure: Number of Participants With Laboratory Test Abnormalities: Expansion Cohort
timeFrame: Baseline up to maximum 1436 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya First Hospital
state: Aichi
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Yamagata-Shi
country: Japan
facility: Yamagata University Hospital
state: Yamagata
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: