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Phase 1 Completed N=16 Treatment

Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

Lymphoma · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT01169532 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Maximum Tolerated Dose (MTD) — 20; 100 milligrams

Summary

This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Tolerated Dose (MTD)
20; 100
SECONDARY
Progression Free Survival
17.1
SECONDARY
Overall Survival
40.7

Eligibility Criteria

Inclusion Criteria

  • Histological or cytological confirmation of a solid, malignant tumor or lymphoma that is refractory to standard therapies or for which no standard therapies exist
  • Patients must have received at least one prior systemic therapy
  • Measureable disease by RECIST v 1.1
  • ECOG PS 0 or 1
  • ANC >= 1500/uL
  • Hgb >= 9 g/dL
  • Platelets >= 100,000/uL
  • AST/SGOT and ALT/SGPT = = 50 ml/min
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test = = 3 weeks earlier; for patients receiving targeted therapy, treatment must be discontinued at least five half-lives prior to initiation of day 1 of study treatment
  • Patients who have taken valproic acid = = 350 mg/dL or serum triglycerides >= 400 mg/d
  • Poorly controlled Type 1 or 2 diabetes, defined as hemoglobin A1C greater than 8% or a fasting glucose of > 160 mg/dL
  • Active infection requiring antibiotics
  • Anaphylactic reaction to macrolide antibiotics, Tween 80 (polysorbate 80)
  • Patients who are not adequately recovered from a prior surgical procedure or major surgical procedure within 2 weeks prior to the first dose of study drug
  • Myocardial infarction of unstable angina within 3 months of study entry
  • NY Heart Association class III or IV congestive heart failure
  • Known active parenchymal brain metastases; patients who have had brain metastases resected, or have received radiation therapy ending > 4 weeks prior to study entry are eligible if they meet all of the following criteria: 1) residual neurologic symptoms = 3 years is allowed
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01169532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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