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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04672460




Registration number
NCT04672460
Ethics application status
Date submitted
13/11/2020
Date registered
17/12/2020
Date last updated
7/12/2022

Titles & IDs
Public title
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
Scientific title
A PHASE 1, OPEN LABEL, CROSSOVER STUDY TO ESTABLISH BIOEQUIVALENCE BETWEEN THE PROPOSED SOFT GEL TALAZOPARIB CAPSULE FORMULATION AND THE CURRENT TALAZOPARIB COMMERCIAL FORMULATION AND TO ESTIMATE THE FOOD EFFECT ON PHARMACOKINETICS OF THE PROPOSED TALAZOPARIB SOFT GEL CAPSULE FORMULATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Secondary ID [1] 0 0
2020-006101-35
Secondary ID [2] 0 0
C3441037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Solid Tumors 0 0
Ovarian Cancer 0 0
Breast Cancer 0 0
Prostate Cancer 0 0
NSCLC 0 0
Pancreatic Cancer 0 0
Colorectal Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TALZENNA capsule
Treatment: Drugs - Talazoparib soft gel capsule
Treatment: Drugs - Talazoparib soft gel capsule

Experimental: Sequence 1 - Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.

Experimental: Sequence 2 - Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.


Treatment: Drugs: TALZENNA capsule
Current commercial talazoparib formulation 1 mg once daily given under fasting condition

Treatment: Drugs: Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition

Treatment: Drugs: Talazoparib soft gel capsule
Proposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC24 of all talazoparib treatment
Timepoint [1] 0 0
24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Primary outcome [2] 0 0
Cmax of all talazoparib treatment
Timepoint [2] 0 0
24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Secondary outcome [1] 0 0
Tmax of all talazoparib treatment
Timepoint [1] 0 0
24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Secondary outcome [2] 0 0
Ctrough of all talazoparib treatment
Timepoint [2] 0 0
24 hours [On Day 27 for Period 1 and on Day 20 for Periods 2]
Secondary outcome [3] 0 0
CL/F of all talazoparib treatment
Timepoint [3] 0 0
24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Secondary outcome [4] 0 0
AUClast of all talazoparib treatment
Timepoint [4] 0 0
24 hours [On Day 28 for Period 1 and on Day 21 for Periods 2 and 3]
Secondary outcome [5] 0 0
Safety and tolerability of the proposed talazoparib soft gel capsule formulation
Timepoint [5] 0 0
Approximately 4 years

Eligibility
Key inclusion criteria
Inclusion Criteria

1. 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.

2. ECOG performance score of 0-1.

3. Adequate bone marrow function:

- ANC =1500 cells/mm3

- Platelets =100,000 cells/mm3

- Hemoglobin =10.0 g/dL

4. 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);
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. For ovarian participants: Non-epithelial tumors or ovarian tumors with low malignant
potential (ie, borderline tumors) or mucinous tumors.

2. 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.

3. Diagnosed with MDS or AML.

4. Active infection requiring systemic therapy within 2 weeks of enrollment.

5. 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).

6. Known or suspected brain metastasis or active leptomeningeal disease undergoing or
requiring treatment. Asymptomatic brain metastases currently not undergoing treatment
are allowed.

7. 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.

8. 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/07/2022
Sample size
Target
Accrual to date
Final
73
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Cancer Therapy Centre - Liverpool
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Epworth Healthcare (Epworth Freemasons Hospital) - East Melbourne
Recruitment hospital [5] 0 0
Epworth Healthcare - East Melbourne
Recruitment hospital [6] 0 0
Epworth Healthcare - Richmond
Recruitment hospital [7] 0 0
Epworth Richmond Hospital (Epworth Healthcare) - Richmond
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04672460
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04672460