NCT00359359

Brief Summary

The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2006

Typical duration for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

2.7 years

First QC Date

July 27, 2006

Last Update Submit

November 3, 2014

Conditions

Carcinoma, Small Cell

Keywords

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin

    Phase 1: Baseline up to 3 month of treatment

  • Phase 2: Efficacy measure

    Phase 2: every 6 weeks after start of treatment

Secondary Outcomes (5)

  • Phase 1: PK of Sagopilone + Cisplatin

    Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion

  • Phase 2: Duration of CR or PR

    every 6 weeks after start of treatment

  • Phase 2: TTP

    every 6 weeks after start of treatment

  • Phase 2: PFS

    every 6 weeks after start of treatment

  • Phase 2: OS

    every 3 months after start of treatment

Study Arms (1)

Sagopilone and cisplatin

EXPERIMENTAL

The study drug sagopilone was administered in combination with a fixed dose of cisplatin

Drug: Sagopilone (BAY86-5302, ZK 219477)Drug: Cisplatin

Interventions

Sagopilone (BAY86-5302, ZK 219477)DRUG

Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID

Sagopilone and cisplatin
CisplatinDRUG

75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1

Sagopilone and cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Small-cell lung cancer
  • Stage of extensive disease
  • Adequate function of major organs and systems
  • Use of highly effective birth control methods in females of child-bearing potential

You may not qualify if:

  • Prior chemotherapy for small-cell lung cancer
  • Superior vena cava syndrome or obstruction of any vital structure
  • Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
  • Known allergy or hypersensitivity to platinum-containing drugs
  • Pregnancy or breast-feeding
  • Use of any investigational drug within 4 weeks before start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Gerlingen, Baden-Wurttemberg, 70839, Germany

Location

Unknown Facility

Löwenstein, Baden-Wurttemberg, 74245, Germany

Location

Unknown Facility

München, Bavaria, 80336, Germany

Location

Unknown Facility

München, Bavaria, 81675, Germany

Location

Unknown Facility

Hamburg, Hamburg, 21075, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 65929, Germany

Location

Unknown Facility

Wiesbaden, Hesse, 65199, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, 45147, Germany

Location

Unknown Facility

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Carcinoma, Small CellSmall Cell Lung Carcinoma

Interventions

sagopiloneCisplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

August 2, 2006

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

August 1, 2009

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

DE(10)