Last updated on December 2018

A Safety and Efficacy Study of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma | Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. 18 years of age 2. Part A:
    • Subjects with histological or cytological confirmation of advanced unresectable solid tumors (including Grade 2 neuroendocrine neoplasms (NENs)/ neuroendocrine tumors (NETs), small cell lung cancer (SCLC), and other neuroendocrine carcinomas (NECs)) or advanced Non-Hodgkin's lymphomas (NHL) (diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL) or marginal cell lymphoma MZL).) 3. Part B:
    • Enrichment for bronchial and prostate NENs will be targeted. Subjects with histological or cytological confirmation of advanced unresectable solid tumors (including G2 NENs/NETs, SCLC, and other NECs) which fall under one of the following categories (G1 NETs are excluded from this study):
    • NECs and G2 NENs/NETs must have:
  2. Appropriate pathological features according to WHO classification
  3. Expression of neuroendocrine markers
  4. Mitotic count 2 per 10 HPF or 2 per 2mm2 and/or 3% Ki67 index

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. low grade (G1) neuroendocrine tumors (<2 per high power fields (HPF) or < 2 per mm2 and/or 2% Ki67 index) such as carcinoid are excluded.
  2. Subject has received anti-cancer therapy (either approved or investigational) 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1..
    • < 42 days for prior nitrosureas or mitomycin C
  3. Toxicities resulting from prior systemic cancer therapies must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to starting CC-90011 treatment (with exception of grade 2 peripheral neuropathy and alopecia).
  4. Prior autologous stem cell transplant 3 months before first dose or those who have not recovered.
  5. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
  6. Subject has undergone major surgery 4 weeks or minor surgery 2 weeks prior to Cycle 1 Day 1 or who have not recovered from surgery.
  7. Subject has completed any radiation treatment < 4 weeks prior to Cycle 1 Day 1 or < 2 weeks for palliative bone radiotherapy (single fraction). Subjects with > 25% of myelopoetic BM radiation are not allowed to be enrolled on this study.
  8. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) NCI CTCAE Grade 2, despite medical management), or any other significant GI disorder that could affect the absorption of CC-90011.
  9. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
  10. Subject with any hemorrhage/bleeding event > CTCAE Grade 2 or haemoptysis > 1 teaspoon within 4 weeks prior to the first dose
  11. Symptomatic and untreated or unstable central nervous system (CNS) metastases as per protocol.
  12. Subject with SCLC that has history of interstitial lung disease (ILD) OR a history of pneumonitis that has required oral or Intra Venous (IV) steroids
  13. Subject has known symptomatic acute or chronic pancreatitis.
  14. Subject has impaired cardiac function or clinically significant cardiac diseases, as per protocol.
  15. Subject has other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure 160/95 mm Hg).
  16. Subject is a pregnant or nursing female.
  17. Subject has known Human immunodeficiency virus (HIV) infection.
  18. Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection.
  19. Subject with ongoing treatment with chronic, therapeutic dosing of anti-coagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonist). Low dose low molecular weight heparin for catheter maintenance and for short-term prophylaxis for subjects with prior PE and DVT are permitted under careful consideration by the Investigator.
  20. Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment.
  21. Subject has any significant medical condition (eg, active or uncontrolled infection or renal disease), laboratory abnormality, or psychiatric illness that would prevent the subject from participating (or compromise compliance) in the study or would place the subject at unacceptable risk if he/she were to participate in the study.
  22. Subject has any condition that confounds the ability to interpret data from the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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