Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I, Open-Label, Dose-Escalation Study of SB-715992 Administered Days 1-3 of a 21-Day Cycle in Patients With Solid Tumors
This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of SB-715992 administered as a 1-hr intravenous
infusion on days 1-3 of a 21-day cycle in patients with solid tumors.
II. To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of
SB-715992 for this administration schedule.
SECONDARY OBJECTIVES:
I. To observe clinical response of SB-715992 given days 1-3, every 21-days. II. To
characterize the pharmacokinetics (PK) of SB-715992 for this administration schedule.
III. To explore drug metabolism, molecular and cellular predictors of efficacy (biomarkers)
and toxicity and drug interaction potential.
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive SB-715992 IV over 1 hour on days 1-3. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SB-715992 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at
the MTD
Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 18-31 patients will be accrued for this study within 11-19
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00126620 -
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 | |
| Completed |
NCT00121277 -
Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 |