NCT01286987 is a Phase 1 clinical trial of Talazoparib in Advanced or Recurrent Solid Tumors, sponsored by Pfizer.

Who is sponsoring NCT01286987?

NCT01286987 is sponsored by Pfizer.

What drugs are being tested in NCT01286987?

Interventions in NCT01286987: Talazoparib.

What condition does NCT01286987 study?

NCT01286987 studies Advanced or Recurrent Solid Tumors, Breast Neoplasms, Ovarian Cancer, Epithelial, Ewing Sarcoma, Small Cell Lung Carcinoma, Prostate Cancer, Pancreas Cancer.

Is NCT01286987 still recruiting?

NCT01286987 is currently completed. Last updated 10 January 2019.

Are results published for NCT01286987?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-10 · How we verify

NCT01286987

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Completed Phase 1 Results posted Last updated 10 January 2019

What this trial tests

Phase 1 trial testing Talazoparib in Advanced or Recurrent Solid Tumors in 113 participants. Completed in 30 January 2017.

Timeline

3 January 2011

Primary endpoint
31 March 2015

30 January 2017

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Masking	none
Primary purpose	treatment
Enrollment	113
Start date	3 January 2011
Primary completion	31 March 2015
Estimated completion	30 January 2017
Sites	15 locations across United Kingdom, United States

Drugs / interventions tested

Talazoparib (talazoparib) — full drug profile →

Conditions studied

Advanced or Recurrent Solid Tumors — all drugs for Advanced or Recurrent Solid Tumors →
Breast Neoplasms — all drugs for Breast Neoplasms →
Ovarian Cancer, Epithelial — all drugs for Ovarian Cancer, Epithelial →
Ewing Sarcoma — all drugs for Ewing Sarcoma →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Advanced or Recurrent Solid Tumors or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Objective Response Primary · From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)

Objective response in participants was defined as the number of participants with complete response (CR) or partial response (PR) after treatment with talazoparib and maintained for at least 4 weeks (28 days) as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. CR defined as disappearance of all non-nodal target lesions (where all target lesions were recorded with a length of 0 millimeter \[mm\] on the case report form \[CRF\]) and the reduction of the shortest diameter of all nodal lesions to less than \[\<\] 10 mm. PR was defined by a 30% or more decrease in the

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	8
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	12
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	2
Part 1 and Part 2: Talazoparib (Ewing Cancer)	0
Part 2: Talazoparib (SCLC Cancer)	2
Part 1 and Part 2: Talazoparib (Prostate Cancer)	0
Part 1: Talazoparib (Colorectal Cancer)	0

Number of Participants With Best Overall Response Primary · From Baseline until disease progression or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)

Best overall response: best response (in the order of confirmed CR, confirmed PR, stable disease \[SD\] and progressive disease \[PD\]) among all overall response as RECIST 1.1, recorded from date of first dose of talazoparib until participant withdrew from study/data cut-off date, whichever earlier. CR defined as disappearance of all non-nodal target lesions (where all target lesions recorded with a length of 0 mm on the CRF) and the reduction of the shortest diameter of all nodal lesions to \< 10 mm. PR defined as at least a 30% decrease in sum of the diameters of target lesions, reference t

Complete Response (CR)

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	1
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	1
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	0
Part 1 and Part 2: Talazoparib (Ewing Cancer)	0
Part 2: Talazoparib (SCLC Cancer)	0
Part 1 and Part 2: Talazoparib (Prostate Cancer)	0

Partial Response (PR)

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	7
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	11
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	2
Part 1 and Part 2: Talazoparib (Ewing Cancer)	0
Part 2: Talazoparib (SCLC Cancer)	2
Part 1 and Part 2: Talazoparib (Prostate Cancer)	0

Stable Disease (SD)

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	7
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	10
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	2
Part 1 and Part 2: Talazoparib (Ewing Cancer)	4
Part 2: Talazoparib (SCLC Cancer)	4
Part 1 and Part 2: Talazoparib (Prostate Cancer)	1

Progressive Disease (PD)

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	5
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	6
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	6
Part 1 and Part 2: Talazoparib (Ewing Cancer)	9
Part 2: Talazoparib (SCLC Cancer)	14
Part 1 and Part 2: Talazoparib (Prostate Cancer)	0

Progression-Free Survival (PFS) Primary · Baseline, until PD or death due to any cause (maximum duration:1071 days for Part 1; 834 days for Part 2)

PFS was defined as the time (in weeks) from the date of first dose of study drug to the earlier date of the documented PD or death due to any cause. PD as per RECIST 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	29.3	12.1 – 43.4
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	32.1	18.9 – 38.6
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	5.3	2.4 – 21.3
Part 1 and Part 2: Talazoparib (Ewing Cancer)	6.2	3.1 – 14.0
Part 2: Talazoparib (SCLC Cancer)	11.1	4.3 – 13.0
Part 1 and Part 2: Talazoparib (Prostate Cancer)	12.1	12.0 – NA

Duration of Response Primary · Baseline until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)

Duration of response was defined as the time (in weeks) from the date of the first documented objective response confirmed at least 28 days later to the date of the first documented PD or date of death, whichever occurred first. PD as per RECIST version 1.1 defined as at least a 20% increase in the sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	32.2	20.1 – 64.1
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	26.9	15.7 – 35.1
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	NA	21.6 – NA
Part 2: Talazoparib (SCLC Cancer)	13.6	12.0 – 15.3

Number of Participants With Stable Disease Primary · Baseline, until PD or death due to any cause (maximum duration: 1071 days for Part 1; 834 days for Part 2)

SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD defined as at least a 20% increase in sum of diameters of target lesions, reference to the smallest sum on study (this includes the baseline sum if that was the smallest on study).

Group	Value	95% CI
Part 1 and Part 2: Talazoparib (Breast Cancer)	7
Part 1 and Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	10
Part 1 and Part 2: Talazoparib (Pancreatic Cancer)	2
Part 1 and Part 2: Talazoparib (Ewing Cancer)	4
Part 2: Talazoparib (SCLC Cancer)	4
Part 1 and Part 2: Talazoparib (Prostate Cancer)	1

Part 1: Maximum Tolerated Dose (MTD) Primary · Cycle 1 (Day 1 up to Day 42)

The MTD was defined as the highest dose at which no more than 1 of 6 participants experienced a Dose Limiting Toxicity (DLT). DLT defined as any of the following occurring during cycle 1 of part 1 of study, Hematologic toxicity: Any grade 4 or higher hematologic adverse event, Grade 3 thrombocytopenia associated with grade 2 or higher haemorrhage, Grade 3 thrombocytopenia or neutropenia that led to interruption of dosing for 5 or more days. Nonhematologic toxicity: grade 3 or higher laboratory AE which was asymptomatic and rapidly reversible adverse events (returned to baseline or to grade 1 o

Group	Value	95% CI
Part 1: Talazoparib: All Participants	1000

Part 1: Recommended Part 2 Dose of Talazoparib Primary · Baseline up to Cycle 50 (each cycle 28 days)

The Recommended dose of talazoparib for use in Part 2 was determined in Part 1 (dose escalation) on the basis of the totality of safety, pharmacokinetics (PK), pharmacodynamic and preliminary efficacy data observed in Cycles 1 and 2 and beyond.

Group	Value	95% CI
Part 1: Talazoparib: All Participants	1000

Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events Secondary · Part 1: Baseline up to 1071 days; Part 2: Baseline up to 834 days

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to 1071 days for Part 1 and up to 834 days for Part 2) that were absent before treatment

AEs

Group	Value	95% CI
Part 1: Talazoparib 25 mcg/Day	2
Part 1: Talazoparib 50 mcg/Day	3
Part 1: Talazoparib 100 mcg/Day	2
Part 1: Talazoparib 200 mcg/Day	3
Part 1: Talazoparib 400 mcg/Day	3
Part 1: Talazoparib 600 mcg/Day	6
Part 1: Talazoparib 900 mcg/Day	6
Part 1: Talazoparib 1000 mcg/Day	6
Part 1: Talazoparib 1100 mcg/Day	6
Part 2: Talazoparib (Breast Cancer)	12
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	11
Part 2: Talazoparib (Pancreatic Cancer)	10

SAEs

Group	Value	95% CI
Part 1: Talazoparib 25 mcg/Day	1
Part 1: Talazoparib 50 mcg/Day	2
Part 1: Talazoparib 100 mcg/Day	2
Part 1: Talazoparib 200 mcg/Day	3
Part 1: Talazoparib 400 mcg/Day	0
Part 1: Talazoparib 600 mcg/Day	2
Part 1: Talazoparib 900 mcg/Day	3
Part 1: Talazoparib 1000 mcg/Day	1
Part 1: Talazoparib 1100 mcg/Day	3
Part 2: Talazoparib (Breast Cancer)	2
Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)	5
Part 2: Talazoparib (Pancreatic Cancer)	6

Part 1: Maximum Observed Plasma Concentration (Cmax) of Talazoparib Secondary · Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Talazoparib 25 mcg/Day	60.0	± 15.9
Part 1: Talazoparib 50 mcg/Day	79.7	± 7.50
Part 1: Talazoparib 100 mcg/Day	214	± 50.9
Part 1: Talazoparib 200 mcg/Day	788	± 369
Part 1: Talazoparib 400 mcg/Day	1830	± 699
Part 1: Talazoparib 600 mcg/Day	4100	± 1400
Part 1: Talazoparib 900 mcg/Day	6100	± 3060
Part 1: Talazoparib 1000 mcg/Day	10600	± 4220
Part 1: Talazoparib 1100 mcg/Day	13200	± 3220

Cycle 1 Day 35

Group	Value	95% CI
Part 1: Talazoparib 25 mcg/Day	300	± 78.8
Part 1: Talazoparib 50 mcg/Day	615	± 74.2
Part 1: Talazoparib 100 mcg/Day	1880	± 332
Part 1: Talazoparib 200 mcg/Day	5620	± 3530
Part 1: Talazoparib 400 mcg/Day	6560	± 1500
Part 1: Talazoparib 600 mcg/Day	11300	± 3230
Part 1: Talazoparib 900 mcg/Day	15400	± 1540
Part 1: Talazoparib 1000 mcg/Day	21000	± 7990
Part 1: Talazoparib 1100 mcg/Day	23400	± 4810

Part 2: Maximum Observed Plasma Concentration (Cmax) of Talazoparib Secondary · Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1

Cycle 1 Day 1

Group	Value	95% CI
Part 2: Talazoparib 1000 mcg	8480	± 3890

Cycle 2 Day 1

Group	Value	95% CI
Part 2: Talazoparib 1000 mcg	17700	± 5790

Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib Secondary · Cycle 1: 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 10, 24, 48, 72 and 96 hours postdose on Day 1 and Day 35

Cycle 1 Day 1

Group	Value	95% CI
Part 1: Talazoparib 25 mcg/Day	7.92	1.95 – 9.95
Part 1: Talazoparib 50 mcg/Day	1.00	0.800 – 1.02
Part 1: Talazoparib 100 mcg/Day	1.02	1.00 – 3.98
Part 1: Talazoparib 200 mcg/Day	1.03	1.00 – 2.32
Part 1: Talazoparib 400 mcg/Day	2.03	0.750 – 2.95
Part 1: Talazoparib 600 mcg/Day	0.835	0.750 – 1.95
Part 1: Talazoparib 900 mcg/Day	2.00	1.02 – 9.98
Part 1: Talazoparib 1000 mcg/Day	1.03	0.730 – 2.07
Part 1: Talazoparib 1100 mcg/Day	1.00	0.730 – 2.05

Cycle 1 Day 35

Group	Value	95% CI
Part 1: Talazoparib 25 mcg/Day	1.02	0.580 – 3.98
Part 1: Talazoparib 50 mcg/Day	5.43	0.770 – 10.1
Part 1: Talazoparib 100 mcg/Day	0.785	0.750 – 0.820
Part 1: Talazoparib 200 mcg/Day	1.97	1.00 – 3.02
Part 1: Talazoparib 400 mcg/Day	0.980	0.750 – 2.00
Part 1: Talazoparib 600 mcg/Day	1.04	0.730 – 5.98
Part 1: Talazoparib 900 mcg/Day	1.02	0.970 – 2.07
Part 1: Talazoparib 1000 mcg/Day	1.02	0.750 – 2.00
Part 1: Talazoparib 1100 mcg/Day	1.48	0.980 – 2.00

Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib Secondary · Cycle 1 and 2: Predose, 0.5, 1, 2, 3 and 4 hours postdose on Day 1

Cycle 1 Day 1

Group	Value	95% CI
Part 2: Talazoparib 1000 mcg	1.00	0.500 – 4.07

Cycle 2 Day 1

Group	Value	95% CI
Part 2: Talazoparib 1000 mcg	1.07	0.500 – 6.05

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to end of study (maximum duration: 1071 days for Part 1; 834 days for Part 2). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: Talazoparib 25 mcg/Day

Serious: 1/3 (33%)

Deaths: —

Part 1: Talazoparib 50 mcg/Day

Serious: 2/3 (67%)

Deaths: —

Part 1: Talazoparib 100 mcg/Day

Serious: 2/3 (67%)

Deaths: —

Part 1: Talazoparib 200 mcg/Day

Serious: 3/3 (100%)

Deaths: —

Part 1: Talazoparib 400 mcg/Day

Serious: 0/3 (0%)

Deaths: —

Part 1: Talazoparib 600 mcg/Day

Serious: 2/6 (33%)

Deaths: —

Part 1: Talazoparib 900 mcg/Day

Serious: 3/6 (50%)

Deaths: —

Part 1: Talazoparib 1000 mcg/Day

Serious: 2/6 (33%)

Deaths: —

Part 1: Talazoparib 1100 mcg/Day

Serious: 3/6 (50%)

Deaths: —

Part 2: Talazoparib (Breast Cancer)

Serious: 2/12 (17%)

Deaths: —

Part 2: Talazoparib (Ovarian/ Peritoneal Cancer)

Serious: 5/11 (45%)

Deaths: —

Part 2: Talazoparib (Pancreatic Cancer)

Serious: 6/10 (60%)

Deaths: —

Part 2: Talazoparib (Ewing Cancer)

Serious: 4/12 (33%)

Deaths: —

Part 2: Talazoparib (SCLC Cancer)

Serious: 8/23 (35%)

Deaths: —

Part 2: Talazoparib (Prostate Cancer)

Serious: 0/3 (0%)

Deaths: —

Serious adverse events (48 terms)

Reaction	System	Part 1: Talazoparib 25 mcg…	Part 1: Talazoparib 50 mcg…	Part 1: Talazoparib 100 mc…	Part 1: Talazoparib 200 mc…	Part 1: Talazoparib 400 mc…	Part 1: Talazoparib 600 mc…	Part 1: Talazoparib 900 mc…	Part 1: Talazoparib 1000 m…	Part 1: Talazoparib 1100 m…	Part 2: Talazoparib (Breas…	Part 2: Talazoparib (Ovari…	Part 2: Talazoparib (Pancr…	Part 2: Talazoparib (Ewing…	Part 2: Talazoparib (SCLC …	Part 2: Talazoparib (Prost…
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rectal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Community acquired infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bile duct obstruction	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anastomotic stenosis	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neuralgia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (305 terms — click to expand)

Reaction	System	Part 1: Talazoparib 25 mcg…	Part 1: Talazoparib 50 mcg…	Part 1: Talazoparib 100 mc…	Part 1: Talazoparib 200 mc…	Part 1: Talazoparib 400 mc…	Part 1: Talazoparib 600 mc…	Part 1: Talazoparib 900 mc…	Part 1: Talazoparib 1000 m…	Part 1: Talazoparib 1100 m…	Part 2: Talazoparib (Breas…	Part 2: Talazoparib (Ovari…	Part 2: Talazoparib (Pancr…	Part 2: Talazoparib (Ewing…	Part 2: Talazoparib (SCLC …	Part 2: Talazoparib (Prost…
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Intestinal obstruction, Dyspnoea, Device related infection, Hyponatraemia, Small intestinal obstruction, Ascites, Abdominal pain, Dyspepsia.

Data from ClinicalTrials.gov NCT01286987 adverse events section.

Sponsor's own description

This is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with DNA-repair pathway deficiencies. There will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation.
Litton JK, Rugo HS, Ettl J, Hurvitz SA, et al · · 2018 · cited 1572× · PMID 30110579 · DOI 10.1056/nejmoa1802905
Regulated cell death (RCD) in cancer: key pathways and targeted therapies.
Peng F, Liao M, Qin R, Zhu S, et al · · 2022 · cited 586× · PMID 35963853 · DOI 10.1038/s41392-022-01110-y
Small cell lung cancer: where do we go from here?
Byers LA, Rudin CM. · · 2015 · cited 486× · PMID 25336398 · DOI 10.1002/cncr.29098
Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
Phase I, Dose-Escalation, Two-Part Trial of the PARP Inhibitor Talazoparib in Patients with Advanced Germline <i>BRCA1/2</i> Mutations and Selected Sporadic Cancers.
de Bono J, Ramanathan RK, Mina L, Chugh R, et al · · 2017 · cited 333× · PMID 28242752 · DOI 10.1158/2159-8290.cd-16-1250
DNA Repair Pathways in Cancer Therapy and Resistance.
Li LY, Guan YD, Chen XS, Yang JM, et al · · 2020 · cited 254× · PMID 33628188 · DOI 10.3389/fphar.2020.629266
Targeting DNA damage response in cancer therapy.
Hosoya N, Miyagawa K. · · 2014 · cited 232× · PMID 24484288 · DOI 10.1111/cas.12366
Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01286987 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 10 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01286987.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01286987

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (48 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Talazoparib

Other recruiting trials for Advanced or Recurrent Solid Tumors

Other Pfizer trials

Verify against primary sources