Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the side effects and best dose of talazoparib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery and liver or kidney dysfunction. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine safety, tolerability and recommended phase 2 dose (RP2D) of talazoparib in patients with varying degrees of hepatic and renal dysfunction.

SECONDARY OBJECTIVES:

I. To observe preliminary antitumor activity of talazoparib in patients with cancers that commonly harbor defects in homologous recombination repair.

II. To assess the pharmacokinetic (PK) profiles of talazoparib in patients with varying degrees of hepatic and renal dysfunction.

III. To evaluate the pharmacodynamic (PD) effects of talazoparib. IV. To evaluate biomarkers associated with response or resistance to talazoparib.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 6 cohorts based on the degree of hepatic or renal dysfunction.

Patients receive talazoparib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Estrogen Receptor Negative
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
  • HER2/Neu Negative
  • Hormone-Resistant Prostate Cancer
  • Lung Neoplasms
  • Mesothelioma
  • Metastatic Pancreatic Adenocarcinoma
  • Ovarian Neoplasms
  • Progesterone Receptor Negative
  • Small Cell Lung Carcinoma
  • Solid Neoplasm
  • Stage III Mesothelioma
  • Stage IIIA Gastric Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Small Cell Lung Carcinoma
  • Stage IIIB Gastric Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Small Cell Lung Carcinoma
  • Stage IIIC Gastric Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IV Mesothelioma
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Small Cell Lung Carcinoma
  • Stomach Neoplasms
  • Triple-Negative Breast Carcinoma

NCT number NCT02567396
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Withdrawn
Phase Phase 1
Start date June 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT03317327 - REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors Phase 1/Phase 2
Terminated NCT02892201 - Pembrolizumab in HNSCC With Residual Disease After Radiation Phase 2
Active, not recruiting NCT04854499 - Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma Phase 2
Terminated NCT04110249 - Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer N/A
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Recruiting NCT05338905 - Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial N/A
Recruiting NCT04045496 - A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors Phase 1
Completed NCT04452214 - A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors Phase 1
Recruiting NCT04096638 - Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT03070366 - Stereotactic Radiotherapy Combined With Chemotherapy or Not for Treatment of Oligometastases in HNSCC Phase 2
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Recruiting NCT02661152 - DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. Phase 3
Terminated NCT02488629 - Study of SCB01A in Patient With Head and Neck Cancer Phase 2
Completed NCT01697800 - A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract Phase 2
Completed NCT01427478 - Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck Phase 3
Recruiting NCT05437380 - Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC N/A
Recruiting NCT05065086 - Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence
Completed NCT03022409 - A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC). Phase 1