- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03220347
Recruitment Status Recruiting
First Posted July 18, 2017
Last update posted August 5, 2020
Study CC-90010-ST-001 is an open-label, Phase 1a, dose escalation and expansion, First-in-human (FIH) clinical study of CC-90010 in subjects with advanced or unresectable solid tumors and relapsed and/or refractory advanced Non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90010 to estimate the maximum tolerated dose (MTD) of CC-90010. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90010 administered at or below the MTD in the following cohorts: Cohort 1: relapsed and/or refractory DLBCL approximately 20-25 evaluable subjects at 45 mg CC-90010 4-days-on/24-days-off in each 28-day cycle Cohort 2: advanced BCC -enrollment stopped due to recruitment challenges Cohort 3: relapsed and/or refractory DLBCL -approximately 15 evaluable subjects at 30mg CC-90010 3-dayson/11-days-offin each 28-day cycle The food effect assessment (Part C, Spain only) will evaluate the impact of food on CC-90010 when administered at the RP2D of 45 mg 4-days-on/24-days-off (180 mg per 28-day cycle), by comparison of the PK parameters following fasted and fed (high-fat, high-calorie meal) conditions.
Parts A, B and C 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-90010. The informed document (ICD) 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-90010. Treatment Period: During the Treatment Period, CC-90010 was initially administered orally once daily for 3 consecutive days followed by 4 consecutive days off drug every week (3/7-days schedule) in each 28-day cycle in Part A. Alternative dosing schedules (eg, 2-days-on/5-days- off each week, 3-days-on/4-days-off every other week, 4-days on/24 days off) may be evaluated one dosing schedule at a time or ≥ 2 dosing schedules given in parallel, based on the review of available safety, PK, pharmacodynamic (PD), and efficacy data by the SRC. Following completion of dose escalation in Part A, selected expansion cohorts will receive CC-90010 in Part B. The SRC determined the RP2D for Part B to be 45 mg CC-90010 given once daily for 4 consecutive days on followed by 24 consecutive days off (4-days-on/24-days-off) in each 28-day cycle. A cohort s of up to approximately 20-25 subjects with relapsed and/or refractory DLBCL (Cohort 1) will be enrolled in Part B expansion. Enrollment in advanced BCC (Cohort 2) will be stopped due to recruitment challenges. An additional cohort of approximately 15 evaluable subjects with R/R DLBCL (Cohort 3) will be enrolled under an alternative dosing regimen of 30 mg CC-90010 3days-on/11-days off in each 28-day cycle. The food effect assessment (Part C, Spain only) will evaluate the impact of food on CC-90010 when administered at the RP2D of 45 mg 4-days-on/24-days-off, by comparison of PK parameters following fasted and fed (high-fat, high-calorie meal) conditions in approximately 24 subjects with advanced solid tumors. Follow-up Period: In the Follow-up Period, subjects will be followed for 28 days (± 3 days) after the last dose of CC-90010 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-90010 in patients with solid tumors and NHL
Subjects will be administered orally once daily for 3 consecutive days followed by 4 consecutive days off drug every week (3/7-days schedule) in each 28 day cycle in Part A. Alternative dosing schedules (eg, 2-days-on/5-days- off each week, 3-days-on/4-days-off every other week, 4-days on/24 days off) may be evaluated one dosing schedule at a time or ≥ 2 dosing schedules given in parallel, based on the review of available safety, PK, pharmacodynamic (PD), and efficacy data.
CC-90010 is an oral, potent and reversible inhibitor of the epigenetic target bromodomain and extra-terminal (BET) proteins.
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.-->
1. Age = or > 18 years.
2. For subjects enrolling in food-effect assessment (Part C) only: a. Subject must agree
and be willing to consume a standard high-fat, high-calorie meal. b. Subject must be
willing to refrain from caffeine or xanthene-containing products (coffee, tea, cola,
chocolate, etc.) for 48 hours prior to dosing on Cycle 1 Day 4 and Cycle 2 Day 4 and
up to 24 hours post dose.
3. Subjects with histological or cytological confirmation of either:
1. In Part A, advanced or unresectable solid tumors or advanced relapsed and/or
refractory Non-Hodgkin lymphoma (ie, Diffuse large B-cell lymphoma and Follicular
lymphoma or Marginal zone lymphoma) including those who have progressed on (or
not been able to tolerate due to medical comorbidities or unacceptable toxicity)
standard anticancer therapy or for whom no other approved conventional therapy
2. In Part B dose expansion, - Cohorts 1 and 3: relapsed and/or refractory DLBCL
following at least 2 prior lines of therapy (e.g. have failed at least one line
of standard therapy and have received at least one prior line of salvage therapy)
OR have failed at least one prior line of standard therapy and are not eligible
for autologous stem cell transplant (ASCT) or have declined ASCT; transformed
lymphoma following chemotherapy for lower grade lymphoma and at least two
standard treatment regimen for DLBCL.
Subjects with two or more lines of systemic therapy must have been treated with and
have lack of response after chimeric antigen receptor (CAR) T-cell therapy, if such
therapy is available, OR be ineligible for CAR T-cell therapy at the time of
enrollment, OR subject declined CAR T-cell therapy.
- Cohort 2: advanced basal cell carcinoma including those who have progressed on (or
not been able to tolerate due to medicalcomorbidities or unacceptable toxicity)
standard anticancer therapy or for whom no other approved conventional therapy exists.
In Part C, advanced or unresectable solid tumors including those who have progressed
on (or not been able to tolerate due to medical comorbidities or unacceptable
toxicity) standard anticancer therapy or for whom no other approved conventional
4. At least one site of measurable disease for subjects with solid tumors;
bi-dimensionally measurable disease on cross sectional imaging with at least one
lesion >1.5 cm for subjects with NHL. For subjects with rare malignancies evaluable
disease can be considered.
5. Tumor biopsies whenever safe and feasible will be collected in Part A, except for
subjects with GBM. Subject consents to mandatory tumor biopsies (Screening and on
treatment) in Part B. In exceptional circumstances an exemption waiver may be granted
by the Sponsor for this criterion
6. ECOG PS of 0 to 1.
7. Either commit to true abstinence or agree to use effective contraceptive methods and
follow pregnancy precautions
Principal Exclusion Criteria
1. Subject has received anti-cancer therapy (either approved or investigational) within
<or= 4 weeks or 5 half-lives, whichever is shorter prior to starting CC-90010. 2. Subject has received prior CAR T-cell therapy or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to starting CC-90010. 3. Toxicities resulting from prior systemic cancer therapies must have resolved. to ≤ NCI CTCAE Grade 1 prior to starting CC-90010 treatment 4. Subject has received autologous hematologic stem cell transplant (HSCT) <or= 3 months prior to starting CC-90010 treatment. Subjects with allogeneic HSCT will not be allowed on this protocol. 5. Major surgery <or= 4 weeks or minor surgery <or= 2 weeks prior to starting CC-90010 or subjects who have not recovered from surgery. 6. Completed radiation treatment < 4 weeks prior to starting CC-90010. 7. Symptomatic, untreated, or unstable central nervous system (CNS) metastases. 8. Known symptomatic acute or chronic pancreatitis. 9. Impaired cardiac function or clinically significant cardiac diseases. 10. Pregnant or nursing females. 12. History of concurrent second cancers requiring active, ongoing systemic treatment. 13. History of clinically significant cognitive disorder(s) or active cognitive disorder(s). 13. Evidence of history of bleeding diathesis. 14. Subjects with known prior episodes of non-arteritic anterior ischemic optic neuropathy (NAION) should be excluded from the study. CC-90010 should be used with caution in subjects with retinitis pigmentosa 15. Any significant medical condition 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. 16. Patients with poor bone marrow reserve as assessed by the Investigator such as in the following conditions: - Having received extensive bone radiotherapy - Having experienced several episodes of bone marrow aplasia in previous treatments - Confirmed histological bone marrow cancer infiltration (with exemption of NHL) - Requiring regular hematopoietic support (blood transfusion, erythropoietin, GCSF)
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 firstname.lastname@example.org
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Gustave Roussy - Cancer Campus
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Istituto Clinico Humanitas
Aichi Cancer Center Hospital
National Cancer Center Hospital East
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Hospital Val d'Hebron
Hospital Universitario Fundacion Jimenez Diaz
Hospital 12 de Octubre
Study Director: Zariana Nikolova, MD, PhD Celgene