Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers (NCT01005797) | Clinical Trial Compass
CompletedPhase 1
Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers
United States38 participantsStarted 2009-11
Plain-language summary
The purpose of this study is to determine if a new investigational drug called Panobinostat is safe, tolerable and to obtain an initial assessment of efficacy, when given in combination with Sorafenib for the treatment of certain types of lung cancer, kidney cancer and soft tissue sarcoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients aged ≥ 18 years old
. ECOG Performance Status of ≤ 2
. Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
. Part A (dose escalation): Histologically or cytologically documented metastatic renal cell carcinoma (RCC) of all histologic types, soft tissue sarcoma (STS) limited to the following histologies: angiosarcoma, liposarcoma, and leiomyosarcoma, or non-squamous non-small-cell lung carcinoma (NSCLC). Parts B (RCC) and C (NSCLC) and D (STS)(expanded cohorts). Patients with RCC must have progressive metastatic disease and received at least one multi-kinase inhibitor (e.g., sorafenib/Nexavar or sunitinib/Sutent), or an mTOR inhibitor (e.g., Temsirolimus). Patients with STS must have progressive disease and have received at least two therapeutic regimens (first-line, second-line treatments).
. Predicted life expectancy ≥ 12 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine maximum tolerated dose (MTD)for LBH 589 in combination with Sorafenib and establish a recommended phase 2 dose for each drug combination
Timeframe: Point in time when no more than 1 of 6 patients has a Dose Limiting Toxicity (DLT) in cycle 1
. Patients may have had prior therapy, providing the following conditions are met:
. Chemotherapy: A minimum of 5 predicted half-lives of the agent must have elapsed between the end of treatment and registration on to the study. When halflives are not available the principle of 2 weeks for once daily medications and 3 weeks for agents given less frequently will be adopted, but discussion with the principal investigator is recommended.
. Radiation: Patients may have had prior radiation therapy that has not exceeded 25% of bone marrow reserve provided that they have recovered from the acute, toxic effects of radiotherapy prior to registration. A minimum of 7 days must have elapsed between the end of radiotherapy to non-target lesions and registration into the study (minimum of 28 days for target lesions).
Exclusion criteria
. NSCLC of squamous histology.
. Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
. Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
. Known or suspected allergy to sorafenib or LBH589
. Impaired cardiac function including any one of the following:
. Uncontrolled hypertension
. Concomitant use of drugs with a risk of causing torsades de pointes (See Appendix 1.-1)
. Concomitant use of CYP3A4 inhibitors (See Appendix 1.-2)