Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00748553

A Phase I/II Clinical Trial of Vidaza With Abraxane in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer — VA  

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:
A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

Clinical Trial Summary

The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Clinical Trial Description

The phase I part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. The purpose of the phase I part is to assess the safety of the investigational treatment and select the recommended phase II dose-regimen. The phase II part of the study will enroll patients with advanced or metastatic HER2-negative breast cancer who have not received treatment for their metastatic disease. The purpose of the phase II part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. The study doctor will determine what phase patients will be enrolled in. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Advanced or Metastatic Breast Cancer
  • Advanced or Metastatic Solid Tumors
  • Breast Neoplasms
Clinical Trial Details
NCT number NCT00748553
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2008
Completion date October 2015
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05017012 - A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of MK-3475A (Pembrolizumab Formulated With MK-5180) In Advanced Solid Tumors (MK-3475A-C18) Phase 1
Completed NCT02261532 - A Phase I Study of TAS-102 in Solid Tumors Phase 1
Completed NCT03248843 - A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05572684 - A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors Phase 1/Phase 2
Terminated NCT04003623 - Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) Phase 2
Terminated NCT05496595 - DCBY02 as a Monotherapy in Patients With Advanced or Metastatic Solid Tumors Phase 1
Active, not recruiting NCT01928394 - A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Terminated NCT01506934 - A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT03730337 - Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT04586270 - A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer Phase 1
Recruiting NCT06248411 - A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors Phase 1
Not yet recruiting NCT06389526 - A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors Phase 1
Completed NCT03665285 - A Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT05957081 - Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 Phase 1
Active, not recruiting NCT03316638 - A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Terminated NCT01355302 - E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer Phase 1/Phase 2
Completed NCT01014429 - Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors Phase 1
Not yet recruiting NCT06074497 - A Phase 1, First-in-Human of KGX101 to Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT06448364 - A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination Phase 1
Active, not recruiting NCT04866134 - A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors Phase 1/Phase 2