Know Cancer

or
forgot password

A Phase I Study of MK-3475 Alone in Subjects With Advanced Solid Tumors and in Combination With Cisplatin/Pemetrexed or Carboplatin/Paclitaxel in Subjects With Advanced Non-Small Cell Lung Cancer


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Solid Tumor, Non-small Cell Lung Cancer

Thank you

Trial Information

A Phase I Study of MK-3475 Alone in Subjects With Advanced Solid Tumors and in Combination With Cisplatin/Pemetrexed or Carboplatin/Paclitaxel in Subjects With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- In Part A: histological or cytological diagnosis of solid tumor, progressive
metastatic disease, or progressive locally advanced disease not amenable to local
therapy

- In Part B: histologically- or cytologically-confirmed diagnosis of NSCLC (Stage
IIIB/IV)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate organ function

Exclusion criteria:

- Cancer therapy within 4 weeks prior to the first dose of study therapy, or not
recovered from the adverse events of agents administered more than 4 weeks prior to
the first dose of study therapy.

- Currently participating or has participated in a study with an investigational agent
or using an investigational device within 30 days of first dose of study therapy

- Expected to require any other form of antineoplastic therapy while on study

- On chronic systemic steroid therapy within two weeks prior to the first dose of trial
treatment or on any other form of immunosuppressive medication

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants experiencing dose-limiting toxicities (DLTs)

Outcome Time Frame:

Cycle 1 (first dose up to 4 weeks)

Safety Issue:

Yes

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

3475-011

NCT ID:

NCT01840579

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms

Name

Location