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A Phase 1a/1b, Multi Center, Open-Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors, Non-Hodgkin's Lymphoma, Multiple Myeloma

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Trial Information

A Phase 1a/1b, Multi Center, Open-Label, Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma


Initially, patients will be treated with oral CC-122 for one month. During this time,
various tests (involving blood and urine collections, ECGs, etc) will be performed. Those
whose tumors stabilize or regress may continue receiving treatment for as long as they
benefit from CC-122. Different dose levels of CC-122 will be tested in a dose-rising study
design.


Inclusion Criteria:



1. Adults with histologically or cytologically-confirmed, advanced Non-Hodgkin's
Lymphoma Multiple Myeloma, or advanced unresectable solid tumors including subjects
who have progressed on (or not been able to tolerate) standard anticancer therapy or
for whom no standard anticancer therapy exists.

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.

3. Adequate organ function.

4. Negative serum or urine pregnancy test within 48 hours before starting study
treatment in females of childbearing potential.

5. Able to adhere to the study visit schedule and other protocol requirements.

6. For the dose expansion part (Part B) of this protocol:

- Retrieval of Formalin-fixed, paraffin embedded archival tumor tissue, either in
tumor blocks or sectioned/mounted specimens for gene mutation and/
Immunohistochemistry biomarker assay for all tumors except Multiple Myeloma.

- Satisfactory Screening biopsy for gene mutation and/or Immunohistochemistry
biomarker assay for accessible tumors for all tumors except Glioblastoma
Multiforme.

7. Histologically-confirmed tumors of the following types, all with measurable disease.
Type-specific criteria are in addition to, or supersede, below criteria where
applicable:

- Metastatic breast cancer.

- Primary glioblastoma multiforme (GBM) or gliosarcoma, excluding World Health
Organization Grade IV oligoastrocytoma:

Exclusion Criteria:

1. Symptomatic central nervous system metastases (excluding GBM). Subjects with brain
metastases that have been previously treated and are stable for 6 weeks are allowed.

2. Known acute or chronic pancreatitis.

3. Any peripheral neuropathy ≥ National Cancer Institute Common Terminology Criteria for
Adverse Events grade 2.

4. Persistent diarrhea or malabsorption ≥ National Cancer Institute Common Terminology
Criteria for Adverse Events grade 2, despite medical management.

5. Impaired cardiac function or clinically significant cardiac diseases, including any
of the following:

- Left Ventricular Ejection Fraction < 45% as determined by Multiple Grade
Acquisition scan or Echocardiogram Complete left bundle branch, or bifascicular,
block.

- Congenital long QT syndrome.

- Persistent or clinically meaningful ventricular arrhythmias or atrial
fibrillation.

- QTcF > 460 msec on screening ECG (mean of triplicate recordings).

- Unstable angina pectoris or myocardial infarction ≤ 3 months prior to starting
CC-122.

- Other clinically significant heart disease such as congestive heart failure
requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mmHg).

6. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.,
active or uncontrolled infection or renal disease) that could cause unacceptable
safety risks or compromise compliance with the protocol.

7. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half
lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not
recovered from side effects of such therapy.

8. Major surgery ≤ 2 weeks prior to starting study drug or still recovering from post
operative side effects.

9. Women who are pregnant or breast feeding. Adults of reproductive potential not
employing two forms of birth control.

10. Known HIV infection.

11. Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in
subjects with HCC.

12. Any significant medical condition, laboratory abnormality, or psychiatric illness
that would prevent the subject from participating in the study.

13. Any condition including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study.

14. Any condition that confounds the ability to interpret data from the study.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose-Limiting Toxicity

Outcome Description:

Dose-limiting toxicities (DLTs) - Grade II or higher toxicity suspected to be drug related

Outcome Time Frame:

28 Days

Safety Issue:

Yes

Principal Investigator

Jorge DiMartino, M.D., Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-122-ST-001

NCT ID:

NCT01421524

Start Date:

August 2011

Completion Date:

March 2014

Related Keywords:

  • Solid Tumors
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • Neoplasm
  • Malignancy
  • Carcinoma
  • Lymphoma
  • Multiple Myeloma
  • Pleiotropic Pathway Modifier
  • DNA-PK inhibitor
  • Advanced Solid Tumors
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasms

Name

Location

Sarah Cannon Research Institute Tennessee Oncology Drug Development UnitNashville, Tennessee  37205
South Texas Accelerated Research Therapeutics, LLC (START)San Antonio, Texas  78229