CompletedNCT04672460Updated Sep 25, 2024Results posted

A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

A Phase 1 interventional study of TALZENNA capsule and Talazoparib soft gel capsule in Advanced Solid Tumors, Solid Tumors and Ovarian Cancer, sponsored by Pfizer. Completed at 31 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 73
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.

Conditions studied

Advanced Solid Tumors
Solid Tumors
Ovarian Cancer
Breast Cancer
Prostate Cancer
NSCLC
Pancreatic Cancer
Colorectal Cancer

Browse trials for

Neoplasms 9,365

Keywords

PARP inhibitor
Talazoparib
Talzenna
BRCA mutation
ATM mutation
Pharmacokinetics
Bioequivalence
Bioavailability
Food effect

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 73 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent.
- Solid tumors with known or likely pathogenic germline or somatic tumor gene defect (eg, one or more BRCA1 or BRCA2 gene defect except for ovarian cancer) that would benefit from PARPi therapy per current approvals for the tumor indication or supported by strong scientific evidence.
- Received at least 1 prior SOC regimen, if it exists, as appropriate for the respective tumor type unless deemed unsuitable or declined these therapies; ovarian cancer participants must have at least 1 prior cytotoxic chemotherapy regimen, including at least 1 course of platinum-based therapy. Participants must not have had disease progression within 6 months of initiation of platinum containing regimen.
ECOG performance score of 0-1.
Adequate bone marrow function:
- ANC ≥1500 cells/mm3
- Platelets ≥100,000 cells/mm3
- Hemoglobin ≥10.0 g/dL
Adequate organ functions:
- CLCR ≥60 mL/min and no documented CLCR \<60 mL/min and no change in CLCR >25% in the past 4 weeks
- AST and ALT ≤2.5 × ULN; if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤5 × ULN;
- Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert's syndrome);

Exclusion criteria

Exclusion Criteria

For ovarian participants: Non-epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors.
Toxicities from previous anti-cancer therapies must be resolved to NCI CTCAE \<Grade 2, except for alopecia, sensory neuropathies ≤Grade 2, or other Grade ≤2 AEs not constituting a safety risk, based on investigator's judgment, are acceptable.
Diagnosed with MDS or AML.
Active infection requiring systemic therapy within 2 weeks of enrollment.
Any condition in which active bleeding or pathological conditions may carry a high risk of bleeding (eg, known bleeding disorder, coagulopathy or tumor involvement with major vessels).
Known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment. Asymptomatic brain metastases currently not undergoing treatment are allowed.
Known history of testing positive for HIV, AIDS, positive HBV surface antigen, positive HCV RNA, or positive COVID-19 viral test. Asymptomatic patients with no active infection detected but positive antibody tests, indicating past infection, are allowed.
Current or anticipated use of P-gp inhibitors, BCRP inhibitors, and P-gp inducers within 2 weeks or 5 half-lives prior to randomization (whichever is longer) .

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 73 participants (actual)

Study arms

Experimental
Sequence 1
Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
Drug: TALZENNA capsule · Drug: Talazoparib soft gel capsule
Experimental
Sequence 2
Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.
Drug: TALZENNA capsule · Drug: Talazoparib soft gel capsule

Interventions

DrugTALZENNA capsule
Current commercial talazoparib formulation 1 mg once daily given under fasting condition
DrugTalazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
DrugTalazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition

What researchers measure

Primary outcomes

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions
Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions
AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions
Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.

Secondary outcomes

Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing
Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period. The geometric coefficient of variation is expressed in percentage.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing
Tmax was defined as time to reach maximum observed plasma concentration.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Predose Concentration During Multiple Dosing (Ctrough) of Talazoparib After Multiple Dosing
Ctrough was the pre-dose concentration during multiple dosing and was directly observed from data. The geometric coefficient of variation is expressed in percentage.
Time frame: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2, predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Time frame: Day 1 up to 28 days after last dose of study drug (maximum up to 388 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Treatment Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Time frame: Day 1 up to 28 days after last dose of study drug (maximum up to 388 days)

Results

Posted Sep 25, 2024

Participant flow

Bioequivalence Phase: Period 1 (28 Days)

Participant flow — Bioequivalence Phase: Period 1 (28 Days)
Milestone	Sequence 1	Sequence 2
Started	35	38
Completed	28	28
Not completed	7	10
Withdrew: Death	1	2
Withdrew: Progressive disease	2	4
Withdrew: Withdrawal by subject	0	3
Withdrew: Global deterioration of health status	0	1
Withdrew: Adverse event	3	0
Withdrew: Other	1	0

Bioequivalence Phase: Period 2 (21 Days)

Participant flow — Bioequivalence Phase: Period 2 (21 Days)
Milestone	Sequence 1	Sequence 2
Started	27	25
Completed	25	20
Not completed	2	5
Withdrew: Progressive disease	1	5
Withdrew: Withdrawal by subject	1	0

Food Effect Phase: Period 3 (21 Days)

Participant flow — Food Effect Phase: Period 3 (21 Days)
Milestone	Sequence 1	Sequence 2
Started	16	14
Completed	11	11
Not completed	5	3
Withdrew: Adverse event	1	0
Withdrew: Progressive disease	3	1
Withdrew: Withdrawal by subject	0	1
Withdrew: Refused further treatment	0	1
Withdrew: Other	1	0

Maintenance Phase: Period 4 (28 Days)

Participant flow — Maintenance Phase: Period 4 (28 Days)
Milestone	Sequence 1	Sequence 2
Started	21	20
Completed	0	0
Not completed	21	20
Withdrew: Adverse event	1	0
Withdrew: Progressive disease	10	12
Withdrew: Refused further treatment	1	0
Withdrew: Other	9	8

Outcome measures

PrimaryArea Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions

AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · nanograms*hour/millilitre (ng*hr/mL)

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions
nanogramshour/millilitre (nghr/mL)	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions	178.7 ± 40	173.0 ± 32

Statistical analysis

Treatment A: Commercial Capsule Fast vs Treatment B: Soft Gel Capsule Fast · Mixed Models Analysis · Ratio (test/reference) of adjusted means: 105.16 · 90% CI 99.00 to 111.70

PrimaryMaximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions

Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · nanograms/millilitre (ng/mL)

Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions
nanograms/millilitre (ng/mL)	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions	14.95 ± 40	19.19 ± 32

Statistical analysis

Treatment A: Commercial Capsule Fast vs Treatment B: Soft Gel Capsule Fast · Mixed Models Analysis · Ratio (test/reference) of adjusted means: 136.62 · 90% CI 125.05 to 149.27

PrimaryArea Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · ng*hr/mL

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions
ng*hr/mL	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed
Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions	173.0 ± 32	151.3 ± 38

Statistical analysis

Treatment B: Soft Gel Capsule Fast vs Treatment C: Soft Gel Capsule Fed · Mixed Models Analysis · Ratio (test/reference) of adjusted means: 87.97 · 90% CI 81.82 to 94.58

PrimaryMaximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · ng/mL

Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions
ng/mL	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed
Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions	19.19 ± 32	11.36 ± 38

Statistical analysis

Treatment B: Soft Gel Capsule Fast vs Treatment C: Soft Gel Capsule Fed · Mixed Models Analysis · Ratio (test/reference) of adjusted means: 58.26 · 90% CI 51.55 to 65.84

SecondaryApparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing

Apparent Clearance After Oral Dose (CL/F) was defined as apparent clearance after oral dose on the last day of treatment period. The geometric coefficient of variation is expressed in percentage.

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · liter per hour (L/hr)

Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing
liter per hour (L/hr)	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed
Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing	5.631 ± 40	5.808 ± 32	6.648 ± 38

SecondaryTime of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing

Tmax was defined as time to reach maximum observed plasma concentration.

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Median · hour

Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing
hour	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed
Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing	2.00 (0.500 to 6.00)	0.975 (0.417 to 4.00)	4.00 (0.967 to 24.7)

SecondaryArea Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing

AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · ng*hr/mL

Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing
ng*hr/mL	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed
Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing	178.5 ± 41	173.4 ± 33	152.1 ± 38

SecondaryPredose Concentration During Multiple Dosing (Ctrough) of Talazoparib After Multiple Dosing

Ctrough was the pre-dose concentration during multiple dosing and was directly observed from data. The geometric coefficient of variation is expressed in percentage.

Time frame:: Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2, predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Reported as:: Geometric mean · ng/mL

Predose Concentration During Multiple Dosing (Ctrough) of Talazoparib After Multiple Dosing
ng/mL	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed
Predose Concentration During Multiple Dosing (Ctrough) of Talazoparib After Multiple Dosing	4.269 ± 48	3.645 ± 44	3.633 ± 60

SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.

Time frame:: Day 1 up to 28 days after last dose of study drug (maximum up to 388 days)
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)
Participants	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed	Maintenance
Participants with adverse events	42	36	15	31
Participants with serious adverse events	9	7	1	7
Participants with Maximum Grade 3 or 4 adverse events	13	10	5	12
Participants with Maximum Grade 5 adverse events	3	4	0	1
Participants discontinued study drug due to adverse events	3	4	1	2
Participants with dose reduced or temporary discontinuation due to adverse events	13	9	6	13

SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) (Treatment Related)

Time frame:: Day 1 up to 28 days after last dose of study drug (maximum up to 388 days)
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Treatment Related)
Participants	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed	Maintenance
Participants with adverse events	22	26	11	16
Participants with serious adverse events	2	0	0	3
Participants with Maximum Grade 3 or 4 adverse events	9	8	4	10
Participants discontinued study drug due to adverse events	1	1	0	1
Participants with dose reduced or temporary discontinuation due to adverse events	9	7	6	12

Adverse events

Collected over From day 1 up to maximum 388 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment A: Commercial Capsule Fast	4/65 (6.2%)	9/65 (13.8%)	25/65 (38.5%)
Treatment B: Soft Gel Capsule Fast	5/60 (8.3%)	7/60 (11.7%)	25/60 (41.7%)
Treatment C: Soft Gel Capsule Fed	0/30 (0%)	1/30 (3.3%)	12/30 (40%)
Maintenance	1/41 (2.4%)	7/41 (17.1%)	20/41 (48.8%)

Most frequent serious events

Showing 10 of 27

Most frequent serious events
Event	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed	Maintenance
Disease progressionGeneral disorders	2/65	3/60	0/30	1/41
AnaemiaBlood and lymphatic system disorders	1/65	0/60	0/30	2/41
Intestinal obstructionGastrointestinal disorders	1/65	0/60	0/30	2/41
Spinal cord compressionNervous system disorders	0/65	0/60	1/30	0/41
ThrombocytopeniaBlood and lymphatic system disorders	2/65	0/60	0/30	1/41
Biliary obstructionHepatobiliary disorders	2/65	0/60	0/30	0/41
Atrial fibrillationCardiac disorders	0/65	0/60	0/30	1/41
NauseaGastrointestinal disorders	0/65	0/60	0/30	1/41
FatigueGeneral disorders	0/65	0/60	0/30	1/41
HypercalcaemiaMetabolism and nutrition disorders	0/65	0/60	0/30	1/41

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Treatment A: Commercial Capsule Fast	Treatment B: Soft Gel Capsule Fast	Treatment C: Soft Gel Capsule Fed	Maintenance
AnaemiaBlood and lymphatic system disorders	7/65	8/60	5/30	11/41
FatigueGeneral disorders	4/65	11/60	2/30	7/41
AlopeciaSkin and subcutaneous tissue disorders	2/65	1/60	2/30	5/41
NauseaGastrointestinal disorders	7/65	5/60	1/30	1/41
Decreased appetiteMetabolism and nutrition disorders	5/65	5/60	0/30	1/41
NeutropeniaBlood and lymphatic system disorders	3/65	2/60	1/30	3/41
DiarrhoeaGastrointestinal disorders	1/65	4/60	1/30	3/41
Platelet count decreasedInvestigations	4/65	4/60	0/30	3/41
HaematuriaRenal and urinary disorders	1/65	0/60	0/30	3/41
Back painMusculoskeletal and connective tissue disorders	1/65	1/60	1/30	3/41

Baseline characteristics

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

Age, Continuous
Age, Continuous(Years)	All Participants
Mean	56.8 ± 9.18

Sex: Female, Male
Sex: Female, Male(Participants)	All Participants
Female	43
Male	30

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Participants
Hispanic or Latino	9
Not Hispanic or Latino	63
Unknown or Not Reported	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	All Participants
White	57
Black or African American	11
Asian	1
Not reported	4

Study locations

31 sites

California Cancer Associates for Research and Excellence, Inc (cCARE)
Encinitas, California 92024, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California 90048, United States
Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
California Cancer Associates for Research and Excellence, Inc (cCARE)
San Marcos, California 92069, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut 06510, United States
Yale-New Haven Hospital
New Haven, Connecticut 06510, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut 06511, United States
Florida Cancer Specialists
Lake Mary, Florida 32746, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri 64114, United States
Montefiore Medical Center
Bronx, New York 10461, United States
NYU Langone Hospital - Long Island Oncology
Mineola, New York 11501, United States
NYU Langone Hospital - Long Island
Mineola, New York 11501, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016, United States
NYU Investigational Pharmacy
New York, New York 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York 10016, United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106, United States
West Chester Hospital
West Chester, Ohio 45069, United States
UPCI Investigational Drug Service
Pittsburgh, Pennsylvania 15232, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232, United States
Upmc Shadyside
Pittsburgh, Pennsylvania 15232, United States
Mary Crowley Cancer Research - Medical City Hospital
Dallas, Texas 75230, United States
NEXT Oncology
San Antonio, Texas 78229, United States
Liverpool Cancer Therapy Centre
Liverpool, New South Wales 2170, Australia
Liverpool Hospital
Liverpool, New South Wales 2170, Australia
Monash Health
Clayton, Victoria 3168, Australia
Epworth Healthcare (Epworth Freemasons Hospital)
East Melbourne, Victoria 3002, Australia
Epworth Healthcare
East Melbourne, Victoria 3002, Australia
Epworth Healthcare
Richmond, Victoria 3121, Australia
Epworth Richmond Hospital (Epworth Healthcare)
Richmond, Victoria 3121, Australia
Epworth Healthcare
East Melbourne, 3002, Australia

References and documents

Study documents

Study protocol · Jun 22, 2021
Statistical analysis plan · Jan 31, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04672460
Lead sponsor: Pfizer
Responsible party: Sponsor
First posted: Dec 17, 2020
Start date: Dec 21, 2020
Primary completion: Feb 4, 2022
Completion: Jul 22, 2022
Results posted: Sep 25, 2024
Last update: Sep 25, 2024

Study contacts

Pfizer CT.gov Call Center

study director · Pfizer

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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