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PARP Inhibitor

Talazoparib soft gel capsule for Ovarian Cancer

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This study is evaluating whether a new formulation of a drug may be more effective than the current formulation.

Eligible Conditions
  • Solid Tumors
  • Ovarian Cancer
  • Breast Cancer
  • Prostate Cancer
  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC24 of all talazoparib treatment
Cmax of all talazoparib treatment
Secondary outcome measures
AUClast of all talazoparib treatment
CL/F of all talazoparib treatment
Ctrough of all talazoparib treatment
+2 more

Side effects data

From 2021 Phase 3 trial • 431 Patients • NCT01945775
48%
Nausea
43%
Fatigue
29%
Neutropenia
28%
Alopecia
25%
Diarrhoea
23%
Headache
22%
Constipation
22%
Decreased appetite
22%
Vomiting
22%
Palmar-plantar erythrodysaesthesia syndrome
19%
Anaemia
17%
Pyrexia
16%
Cough
15%
Back pain
15%
Dyspnoea
14%
Abdominal pain
14%
Neutrophil count decreased
12%
Aspartate aminotransferase increased
12%
Alanine aminotransferase increased
12%
Weight decreased
12%
Arthralgia
12%
Paraesthesia
11%
Pain in extremity
11%
Myalgia
10%
Dizziness
10%
Leukopenia
10%
Upper respiratory tract infection
10%
Asthenia
10%
Rash
9%
Dysgeusia
8%
Oropharyngeal pain
8%
Dyspepsia
8%
Insomnia
7%
Musculoskeletal pain
7%
Mucosal inflammation
7%
Musculoskeletal chest pain
7%
Lacrimation increased
7%
Dry skin
7%
Hot flush
7%
Neuropathy peripheral
7%
Anxiety
6%
Viral upper respiratory tract infection
6%
Bone pain
6%
Pleural effusion
6%
Thrombocytopenia
6%
Dry mouth
6%
Oedema peripheral
6%
Stomatitis
6%
Peripheral sensory neuropathy
5%
Neck pain
4%
Non-cardiac chest pain
4%
White blood cell count decreased
4%
Abdominal pain upper
3%
Sinusitis
3%
Platelet count decreased
3%
Depression
2%
Influenza like illness
2%
Urinary tract infection
2%
Muscle spasms
2%
General physical health deterioration
2%
Pneumonia
2%
Dehydration
2%
Nervous system disorder
2%
Deep vein thrombosis
1%
Pathological fracture
1%
Muscular weakness
1%
Encephalopathy
1%
Bronchopneumopathy
1%
Febrile neutropenia
1%
Colitis
1%
Localised oedema
1%
Sepsis
1%
Staphylococcal bacteraemia
1%
International normalised ratio increased
1%
Malignant pleural effusion
1%
Acute promyelocytic leukaemia
1%
Malignant melanoma
1%
Pericarditis malignant
1%
Second primary malignancy
1%
Salpingo-oophorectomy
1%
Cerebrovascular accident
1%
Uterine haemorrhage
1%
Lymphadenectomy
1%
Cellulitis
1%
Device related infection
1%
Discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Physician's Choice Treatment
Talazoparib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sequence 2Experimental Treatment2 Interventions
Participants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.
Group II: Sequence 1Experimental Treatment2 Interventions
Participants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib soft gel capsule
2020
Completed Phase 1
~80
TALZENNA capsule
2020
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,405 Total Patients Enrolled
20 Trials studying Ovarian Cancer
2,713 Patients Enrolled for Ovarian Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,519 Total Patients Enrolled
12 Trials studying Ovarian Cancer
2,179 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04672460.
~17 spots leftby Apr 2025
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