A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Conditions

• Adolescent
• Child
• Neoplasms

Eligibility Criteria

Sex

ALL

Age

1 Year - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Ramucirumab — DRUG
  Administered IV
• Cyclophosphamide — DRUG
  Administered orally
• Vinorelbine — DRUG
  Administered IV
• Gemcitabine — DRUG
  Administered IV
• Docetaxel — DRUG
  Administered IV
• Abemaciclib — DRUG
  Administered orally
• Irinotecan — DRUG
  Administered IV
• Temozolomide — DRUG
  Administered orally

Study Details

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Key Dates

Start date

Jan 22, 2020

Status verified

Mar 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

105 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ramucirumab + Cyclophosphamide + Vinorelbine (DSRCT ISA)
  Ramucirumab given intravenously (IV), cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for desmoplastic small round cell tumor (DSRCT) intervention-specific appendix (ISA).
• Active Comparator: Cyclophosphamide + Vinorelbine (DSRCT ISA)
  Cyclophosphamide given orally and vinorelbine given IV in 28-day cycles for DSRCT ISA.
• Experimental: Ramucirumab + Gemcitabine + Docetaxel (SS ISA)
  Ramucirumab and gemcitabine given IV in 21-day cycles for synovial sarcoma (SS) ISA.
• Active Comparator: Gemcitabine + Docetaxel (SS ISA)
  Gemcitabine and docetaxel given IV in 21-day cycles for SS ISA.
• Experimental: Abemaciclib + Irinotecan + Temozolomide (ES ISA)
  Abemaciclib given orally, irinotecan given IV, and temozolomide given orally in 21-day cycles for Ewing's sarcoma (ES) ISA.
• Active Comparator: Irinotecan + Temozolomide (ES ISA)
  Irinotecan given IV and temozolomide given orally in 21-day cycles for ES ISA.

Primary Outcome Measure

Number of Participants Allocated to Each ISA [ Time Frame: Baseline up to Week 4 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (30)

Find similar trials in Birmingham, AL

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