Clinical Trials Logo

Clinical Trial Summary

The subjects are being asked to take part in the Phase I or Phase II portion of a research study of a new investigational drug, LBH589, in combination with chemotherapeutic agents, carboplatin with etoposide. LBH589 (made by Novartis Pharmaceuticals Corp.) is considered "investigational" because it has not been approved for commercial use in the treatment of cancer by the U.S. Food and Drug Administration (FDA). Etoposide and carboplatin are chemotherapeutic agents approved by the FDA for the treatment of for small cell lung cancer.

LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes (proteins produced by cells). LBH589 has shown effects against cancer in laboratory studies and in studies using animals; however, it is not known if this medicine will show the same activity in humans. As of May 2006, approximately 100 patients have received treatment with either an intravenous or capsule form of LBH589. Only the capsule form of LBH589 will be used in this study.

The main goal during the Phase I portion of this research study is to find out the highest and safest dose of LBH589 that can be given in combination with carboplatin with etoposide in subjects with lung cancer without causing severe side effects. The main goal of the Phase II portion of this study is to find how the subject's lung cancer responds to the LBH589 in combination with carboplatin and etoposide at the highest and safest dose that was given in Phase I.

The subject may be enrolled in either Phase I or Phase II of the trial, depending on when they entered the study, but they will not be enrolled in both phases.

This study will also investigate how the subject's body processes the combination of LBH589 and carboplatin with etoposide. To determine this, the investigators will measure the amount of study drug in the subject's blood. This will be done with a series of blood tests, called pharmacokinetic (PK) tests. Pharmacokinetics is the study of how the study drug moves through the body. Other purposes of this study will be to sample the subject's genetic material (DNA/RNA) as well as to determine biomarkers in their blood. (For some cancers, biomarkers are a way to measure the extent of their disease or the effects of treatment.) These samples will also be stored for future studies.


Clinical Trial Description

Treatment plan

- LBH589 will be given in oral formulation starting at a dose of 10 mg (Dose Level 1) three times per week (doses will be given at least 2 days apart, e.g. Monday, Wednesday, Friday), 2 out of 3 weeks dosing schedule.

- After establishing the MTD of LBH589 at a 2 out 3 weeks dosing schedule, a 3 out of 3 weeks dosing schedule will be tested at that dose, and this schedule will be adopted in the absence of limiting toxicities.

- Carboplatin will be given on day 1, every 21 days, and etoposide on days 1,2,3 every 21 days for up to 6 cycles. LBH589 will be continued weekly, three times-a-week, without interruption after completion of 6 cycles of combination chemotherapy until progression, or intolerable toxicities.

In the phase I part and for cycle 1 only, for the purpose of the PK studies LBH589 will start the week prior to the first carboplatin/etoposide cycle and PD studies will be performed (week -1).

Study design and sample size:

This is a phase I/II study. Phase I: 15-24 patients (estimated; Three to six patients will be enrolled at each dose level); Phase II: 39 patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00958022
Study type Interventional
Source University of Pittsburgh
Contact
Status Terminated
Phase Phase 1
Start date September 2009
Completion date June 2011

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03651219 - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03958045 - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma Phase 2
Active, not recruiting NCT04885998 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) Phase 1
Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
Not yet recruiting NCT02875457 - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin Phase 3
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Recruiting NCT02605811 - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer Phase 2
Withdrawn NCT02542137 - Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2
Completed NCT02551432 - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer Phase 2
Recruiting NCT02262897 - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer Phase 2
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A
Terminated NCT00969306 - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients Phase 1
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3
Terminated NCT00702962 - Carboplatin and Etoposide in Combination With Vorinostat for Patients With Extensive Stage Small Cell Lung Cancer Phase 1/Phase 2
Recruiting NCT00686985 - Docetaxel - Carboplatin as Second Line Treatment in Patients With Small Cell Lung Cancer Phase 2