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A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)

Phase 1
18 Years
Open (Enrolling)
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Study of Ridaforolimus and Vorinostat in Patients With Advanced Solid Tumors or Lymphoma (IND 109130)


I. To determine which dose combinations of Ridaforolimus and Vorinostat are safe and

II. To define the maximum tolerated dose. III. To characterize dose limiting toxicities.


I. To describe the activity of this combination amongst all enrolled patients in terms of
response rate, progression free survival and overall survival.

II. To describe the activity of this combination in the subset of patients with RCC in terms
of response rate, progression free survival and overall survival.

III. To describe the pharmacodynamic effects of these agents in combination.

OUTLINE: This is a dose escalation study.

Patients receive ridaforolimus orally (PO) once daily on days 1-5 and vorinostat PO twice
daily on days 1-3. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every three months for up to 3

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 =< 2.5 x upper limit of normal (ULN) or =< 5.0 x ULN in
patients with liver metastases

- Total Bilirubin =< 1.5 times ULN

- Creatinine =< 2.0 mg/dL or Creatinine Clearance (calculated or 24 hour urine) >= 50

- Female patients of childbearing potential must have a negative serum or urine
pregnancy test =< 21 days of study enrollment and agree to use an effective method of
contraception for the duration of the study

- Ability to understand and willingness to sign written informed consent

Exclusion Criteria:

- Prior anti-cancer treatment with either an mTOR inhibitor (i.e. temsirolimus,
everolimus), or an HDAC inhibitor (i.e. Vorinostat)

- Patients who have received bevacizumab =< 6 weeks prior to day 1 of study treatment;
patients who have received other chemotherapy, immunotherapy, or radiotherapy =< 3
weeks prior to day 1 of study treatment or those who have not recovered from acute
adverse events due to agents administered >= 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 =< 2 weeks of study enrollment; valproic acid
is another HDAC inhibitor

- Patients who are pregnant, plan to become pregnant, or are breastfeeding

- History of gastrointestinal bleeding within1 month of enrollment

- Serum cholesterol >= 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 < grade 1, 2) no steroid requirement, 3) a follow-up MRI shows regression or
stability of lesions after treatment, with no new lesions appearing

- Unable to swallow whole pills

- A requirement for one of the prohibited medications; if patient is currently taking
one of these medications, they may be eligible so long as they discontinue the
prohibited medication prior to starting study treatment and remain off for the
duration they are taking study treatment

- Known diagnosis of HIV

- Concurrent malignancies are excluded with the following exceptions: basal cell skin
cancer is allowed; cervical carcinoma in situ is allowed; any malignancy that does
not require active treatment, and from which the patient has been disease free for >=
3 years is allowed

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of study treatment

Outcome Description:

Assessed by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.0.

Outcome Time Frame:

First 3 weeks of treatment

Safety Issue:


Principal Investigator

Elizabeth Plimack

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

Related Keywords:

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Lymphoma
  • Neoplasms



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111