Clinical trial · Interventional
A Research Study to Evaluate the Safety of R306465, a Drug in Development for Cancer and to Study the Absorption, Break Down and Elimination in Patients With Advanced Solid Malignancies.
A Phase I Study to Evaluate the Safety and Pharmacokinetics of R306465 in Subjects With Advanced Solid Malignancies
NCT00677001CI-TRIAL-00003401completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety of R306465 (a drug in development for cancer) in patients with advanced cancer on the maximum dose that can be tolerated. Also, the absorption, breakdown and elimination of the drug will be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R306465 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the safety and maximum tolerated dose of R306465 when given as a daily oral dose during 3 weeks followed by a 1 week recovery period. Study the absorption, break down and elimination of R306465 following oral administration.
Secondary outcomes (1)
- measure
- Investigate the effect of food on oral administration of R306465. Evaluate the antitumor activity of R306465 in patients with measurable cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed solid malignancy that is metastatic or unresectable, and for which standard curative or palliative measures does not exist or are no longer effective * Performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2 * Life expectancy \> 3 months * Adequate gastrointestinal absorption status * Must meet protocol-defined criteria for lab assessments and adequate bone marrow, liver, and kidney function. Exclusion Criteria: * Known central nervous system metastases * Chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug administration or incomplete recovery from preceding surgery * Previous participation in a clinical study with histone deacetylase (HDAC) inhibitor or another investigational anticancer agent within 4 weeks of dosing with R306465 * Patient has signs and symptoms of acute infection requiring systemic therapy * Patient is not recovered from reversible toxicity of prior anticancer therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.