Clinical Trials Logo
  1. Home
  2. Metastatic Solid Tumor
  3. NCT00611468

Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors

Metastatic Solid Tumor Clinical Trial

Official title:
A Phase I, Dosage-finding and Pharmacokinetic Study of Intravenous Topotecan and Oral Erlotinib in Adults With Refractory Solid Tumors

Clinical Trial Summary

The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.

Clinical Trial Description

The primary objectives of this trial include:

- To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib.

- To define the dosage-limiting toxicities (DLT) of this combination.

- To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib

The secondary objectives include:

- To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination

- To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics

- To measure the frequency of UGT genotypes in peripheral blood samples

- To evaluate the objective response rate using the RECIST criteria. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00611468
Study type Interventional
Source Accelerated Community Oncology Research Network
Contact
Status Completed
Phase Phase 1
Start date June 2006
Completion date August 2009
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT05071183 - A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT05530200 - PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors. Phase 2
Active, not recruiting NCT04447651 - Patient Response to Immunotherapy Using Spliceosome Mutational Markers (PRISMM)
Recruiting NCT04419532 - A Study Evaluating DS-1055a in Participants With Relapsed or Refractory Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT04137900 - Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody Specific to B-and T-Lymphocyte Attenuator (BTLA) as Monotherapy and in Combination With an Anti-PD1 Monoclonal Antibody for Injection in Subjects With Advanced Malignancies Phase 1
Recruiting NCT04585750 - The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) Phase 1/Phase 2
Not yet recruiting NCT05028478 - A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT05867121 - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05471271 - IL-2 PET Imaging in Advanced Solid Tumours N/A
Active, not recruiting NCT03964727 - Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors Phase 2
Recruiting NCT06108050 - JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors Phase 1
Recruiting NCT05688280 - Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS Phase 1/Phase 2
Completed NCT04914117 - A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours Phase 1
Completed NCT00997529 - Mini Allo Stem Cell Transplantation for the Treatment of Solid Tumors N/A
Recruiting NCT04614740 - The Phase I/Phase II Clinical Study of VC004 in Patients With Localized Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05824975 - A Study to Evaluate the Safety and Therapeutic Activity of GI-102 in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05694715 - Combination Therapy in Cancers With Mutations in DNA Repair Genes Phase 1