New drug combo tested for advanced cancers
NCT ID NCT01281176
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing two different doses of vorinostat (a drug that blocks enzymes needed for cancer cell growth) combined with either carboplatin or paclitaxel (standard chemotherapy drugs) in 20 people with advanced solid tumors that have not responded to other treatments. The main goal is to measure drug levels in the blood and check for side effects. This study aims to find safer and more effective ways to combine these drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vorinostat (a drug that may block enzymes needed for cancer cell growth) combined with carboplatin or paclitaxel (standard chemotherapy drugs)
- What this could lead to
- If successful, this could help determine safe and effective doses of vorinostat combined with chemotherapy for advanced solid tumors, potentially improving treatment options.
- What could go wrong
- This is a very early phase 1 trial with only 20 participants, so results may not apply to larger populations. Side effects from the drug combinations are unknown and could be severe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Feb 2011
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which no superior curative or palliative measures are known * At least 4 weeks must have passed since prior chemotherapy or radiation therapy; 6 weeks if the last regimen included BCNU or mitomycin C * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy of greater than 3 months * Leukocytes \> 3,000/mcL * Absolute neutrophil count \> 1,500/mcL * Platelets \> 100,000/mcL * Total bilirubin \< institutional upper limits of normal * Potassium \< institutional upper limits of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 X institutional upper limit of normal, or \< 5 x ULN if liver metastases are present * Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (except alopecia, lymphopenia, hyperglycemia, hypoalbuminemia and elevated serum alkaline phosphatase); all other toxicities should have resolved to grade 1 or less prior to beginning treatment * Patients may not be receiving any other investigational agents * Patients with known brain metastases that are untreated or have progressed after definitive therapy should be excluded from this clinical trial; patients with treated brain metastases, who are no longer receiving steroids for at least 14 days, are not receiving enzyme-inducing anti-epileptic drugs, and have no unstable neurologic symptoms may be enrolled at the discretion and joint decision of the principal investigator and treating physician * Prior or current use of valproic acid, a histone deacetylase (HDAC) inhibitor * History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, vorinostat or carboplatin * Inability to swallow oral medications * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women that are pregnant or breastfeeding are excluded from this study; all women of child-bearing potential must have a negative pregnancy test before receiving vorinostat; women of child-bearing potential and men must agree to use adequate contraception for the duration of the study; breastfeeding should be discontinued if the mother is treated with vorinostat; these potential risks may also apply to other agents used in this study; subjects that become pregnant or think they may be pregnant while taking part in this study should notify their treating physician immediately * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adult solid neoplasm are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors