- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT02875223
Recruitment Status Recruiting
First Posted August 23, 2016
Last update posted October 1, 2020
Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including transformed MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.
Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up. Screening Period The Screening Period starts 28 days (± 3 days) prior to first dose of CC-90011. The informed consent form (ICF) must be signed and dated by the subject and the administering staff prior to the start of any other study procedures. All screening tests and procedures must be completed within the 28 days (±3 days) prior to the first dose of CC-90011. Treatment Period During the Treatment Period, CC-90011 will initially be administered orally in each 4-week (28 day) Cycle in Part A. In September 2018, after completion of Part A, the SRC determined the RP2D to be 60 mg CC 90011 once weekly (QW) in each 28-day cycle. In Part B, 3 cohorts, of approximately 10-20 evaluable subjects each, with advanced low/intermediate-grade lung NETs, NEPCs, R/R NHL (MZL, including transformed MZL) will receive the RP2D to further evaluate safety, PK, PD and preliminary efficacy. Follow-up Period In the Follow-up Period, subjects will be followed for 28 days (± 3 days) after the last dose of CC-90011 for safety. After the Safety Follow-up visit, all subjects will be followed every subsequent 3 months (± 2 weeks) for survival follow-up for up until 2 years or until death, lost to follow-up, or the End of Trial, whichever occurs first.
|Experimental: CC-90011 Administration
Subjects will administer CC-90011 orally once weekly in each 4 -week (28 day) Cycle. Alternative dosing schedules may be implemented based on the review of clinical safety and laboratory data by the SRC. CC-90011 will be administered with at least 240 mL of water. Subjects should fast for a minimum of 4 hours in both Parts A and B prior to CC-90011 administration and refrain from any food intake for up to 1 hour after dosing
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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
R/R Non-Hodgkin's lymphomas (NHL) (diffuse large B cell lymphoma (DLBCL) and
follicular lymphoma (FL) or marginal cell lymphoma MZL))
3. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L without growth factor support for 7 days
(14 days if subject received pegfilgastrim)
4. Hemoglobin (Hgb) ≥ 10 g/dL (≥ 100 g/L or > 6.2 mmol/L)
5. Platelet Count
- Platelet count (plt) ≥ 100 x 109/L (≥ 50 x 109/L for NHL subjects) or ≥ 75 x
109/L for HCC or NEHCC subjects with portal hypertension without transfusion for
7 days (Part A).
- Platelet count (plt) ≥ 150 x 109/L (Part B, solid tumor cohort in particular NET
- Platelet count (plt) ≥ 50 x 109/L (Part B, NHL cohort)
6. Part B:
Neuroendocrine tumors: Subjects with histological or cytological confirmation of advanced
unresectable solid tumors (including low/intermediate-grade lung NETs, and Prostrate NECs
(NEPCs)) which fall under one of the following categories:
B) Lung NETs:
Subjects with demonstrated tumor progression in the last 12 months on last prior therapy
assessed by CT/MRI scan in the following 2 histologies.
i. Typical carcinoid (TC) ii. Atypical carcinoid (AC)
C) Prostate NECs (NEPCs):
1. Appropriate pathological features according to WHO classification
2. Expression of neuroendocrine markers
3. Mitotic count ≥ 2 -10 per 10 HPF or ≥ 2-10 per 2mm2 and/or ≥ 3% Ki67 index (if
D) R/R NHL:
Subjects with MZL, including histologic transformation of MZL relapsed/refractory after ≥2
prior therapies and ineligible for potentially curative therapy with the adequate
Subjects must have progressed on (or not been able to tolerate due to medical comorbidities
or unacceptable toxicity), or following standard anticancer therapy or for whom no other
approved conventional therapy exists or is acceptable
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
5. Prior allogeneic stem cell transplant with either standard or reduced intensity
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 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
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
15. Subject has other clinically significant heart disease such as congestive heart
failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm
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
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. Subjects with poor bone marrow reserve as assessed by Investigator such as in the
following conditions of (Part B only):
- Having received extensive bone radiotherapy
- Having experienced several episodes of bone marrow aplasia in previous treatments
- Confirmed histological bone marrow cancer infiltration
- Requiring regular hematopoietic support (blood transfusion, erythropoietin,
23. Subject has any condition that confounds the ability to interpret data from the study.
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 firstname.lastname@example.org
Centre Georges Francois Leclerc
Institut Paoli Calmettes
Marseille Cedex 9
Istituto Nazionale Dei Tumori
Istituto Europeo di Oncologia
Hospital Universitario Vall D hebron
Fundacion Jimenez Daaz
Hospital Universitario Marques de Valdecilla
Royal Marsden Hospital
Newcastle Upon Tyne
Study Director: Zariana Nikolova, MD, PhD Celgene Corporation
Principal Investigator: Johann De Bono, MD, PhD Royal Marsden NHS Foundation Trust
Principal Investigator: Antoine Hollebecque, MD Gustave Roussy, Cancer Campus, Grand Paris