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

  • Clinicaltrials.gov identifier

    NCT02875223

  • Recruitment Status

    Recruiting

  • First Posted

    August 23, 2016

  • Last update posted

    April 18, 2022

Study Description

Brief summary:

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 extranodal MZL [EMZL], splenic MZL [SMZL], nodal MZL [NMZL], and histologic transformation of 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.

  • Condition or Disease:Lymphoma, Non-Hodgkin
    Neoplasms
  • Intervention/Treatment: Drug: CC-90011
    Drug: Rifampicin
    Drug: Itraconazole
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 91 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
  • Actual Study Start Date: August 2016
  • Estimated Primary Completion Date: April 2025
  • Estimated Study Completion Date: April 2025

Arms and interventions

Arm Intervention/treatment
Experimental: CC-90011 and Itraconazole
Drug: CC-90011
Specified dose on specified days

Drug: Itraconazole
Specified dose on specified days
Experimental: CC-90011 and Rifampicin
Drug: CC-90011
Specified dose on specified days

Drug: Rifampicin
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]
    Number of participants with DLT
  • 2. Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria [ Time Frame: Up to approximately 28 days ]
  • 3. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 9 years ]
  • 4. Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to approximately 9 years ]
  • 5. AUC from time zero to the last quantifiable concentration (AUC0-t) [ Time Frame: Up to approximately 9 years ]
  • Secondary Outcome Measures: 1. Clinical Benefit Rate (CBR) determined by response and stable disease rates by disease appropriate response criteria [ Time Frame: Up to approximately 8 years ]
    Is defined as tumor responses (as assessed by the Investigators) of complete response (CR), partial response (PR) and durable stable disease (SD) (SD of ≥ 4 months duration)
  • 2. Objective Response Rate (ORR) [ Time Frame: Up to approximately 8 years ]
    Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR)
  • 3. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 8 years ]
    Is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause
  • 4. Overall Survival (OS) [ Time Frame: Up to approximately 8 years ]
    Is measured as the time from the first dose of CC-90011 to death due to any cause
  • 5. Duration of Response (DOR) [ Time Frame: Up to approximately 8 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: 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 therapy exists Eastern Cooperative Oncology Group Performance Status of 0 to 1 Exclusion Criteria: Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered Symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages Impaired cardiac function or clinically significant cardiac diseases Poor bone marrow reserve as assessed by Investigator Refer to protocol defined exclusion criteria for parts C and D. Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

France
Centre Georges Francois Leclerc
Dijon

France
Institut Paoli Calmettes
Marseille Cedex 9

France
Gustave Roussy
Villejuif Cedex

Italy
Bologna University
Bologna

Italy
Istituto Nazionale Dei Tumori
Milano

Italy
Istituto Europeo di Oncologia
Milano

Japan, Tokyo
Local Institution - 501
Chuo-ku

Japan, Tokyo
National Cancer Center Hospital
Chuo-ku

Japan, Tokyo
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Koto-ku

Japan, Tokyo
Local Institution - 502
Koto

Japan
Local Institution - 500
Kashiwa

Japan
National Cancer Center Hospital East
Kashiwa

Spain
Hospital Universitario Vall D hebron - PPDS
Barcelona

Spain
Fundacion Jimenez Daaz
Madrid

Spain
Hospital 12 de Octubre
Madrid

Spain
Hospital Universitario Marques de Valdecilla
Santander

United Kingdom
Local Institution - 300
London

United Kingdom
Royal Marsden Hospital
London

United Kingdom
Freeman Hospital
Newcastle Upon Tyne

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information