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A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Non Small Cell Lung Cancer (NSCLC)

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Trial Information

A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy


This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of
SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until
progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm
Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part
will be initiated.

In the Randomized Part approximately 200 patients (100 per arm) will be randomized to
receive SPI-1620 plus docetaxel or docetaxel alone.

In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel
75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the
control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or
intolerable toxicity.


Inclusion Criteria:



- Histologically or cytologically confirmed locally advanced or metastatic NSCLC that
has failed one prior platinum-containing chemotherapy

- Measurable disease as per RECIST v. 1.1

- ECOG performance status of 0, 1 or 2

- Adequate bone marrow, liver and renal function

Exclusion Criteria:

- More than one prior chemotherapy regimen for metastatic NSCLC

- Known, uncontrolled CNS metastases

- Significant circulatory disorders in the past 6 mo.

- Concomitant treatment with phosphodiesterase inhibitors

- Uncontrolled orthostatic hypotension, asthma or COPD

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate(ORR) of SPI-1620

Outcome Description:

To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

David M Waterhouse, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Hematology Care Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SPI-1620-12-201

NCT ID:

NCT01741155

Start Date:

May 2013

Completion Date:

November 2014

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Oncology Hematology Care Inc. Cincinnati, Ohio  45242
Virginia Cancer Institute Richmond, Virginia  23230