NCT00941863

Brief Summary

The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors. The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_1

Geographic Reach
1 country

3 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, 2002

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 8, 2010

Completed
Last Updated

March 22, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

June 12, 2009

Results QC Date

February 3, 2010

Last Update Submit

February 24, 2016

Conditions

Carcinoma

Keywords

SorafenibAdvanced Solid TumorsMaximum tolerated doseCarboplatin and paclitaxel chemotherapy combination

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin

    MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets \< 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); CTC Version 2 were used.

    21 days

  • Participants With Hematological and Biochemical Toxicities

    Participants are considered at risk for toxicity if participants had a lab measurement for the toxicity \>= National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade 3 as defined by the NCI CTC version 2; SGOT: Serum Glutamic-Oxaloacetic Transaminase, SGPT: Serum Glutamic-Pyruvic Transaminase, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase.

    Start of treatment until death or within 14 days last study drug intake

Secondary Outcomes (4)

  • Tumor Response

    From start of treatment until progression or death occurs assessed every 6 weeks.

  • Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1

    At day 2 in study

  • Maximum Concentration (CMAX) Start From Day 2 of Cycle 1

    At day 2 in study

  • Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1

    At day 2 in study

Other Outcomes (2)

  • Serious Adverse Events

    From start of treatment until 18 Sep 2008, up to 6 years

  • Other Adverse Events

    From start of treatment until 18 Sep 2008, up to 6 years

Study Arms (5)

Sorafenib 100 mg (50-mg tablet)

EXPERIMENTAL

Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).

Drug: Sorafenib 100 mg (50-mg tablet)

Sorafenib 200 mg (50-mg tablet)

EXPERIMENTAL

Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).

Drug: Sorafenib 200 mg (50-mg tablet)

Sorafenib 400 mg (50-mg tablet)

EXPERIMENTAL

Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).

Drug: Sorafenib 400 mg (50-mg tablet)

Sorafenib 400 mg (200-mg tablet)

EXPERIMENTAL

Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet). Treatment were planned until primary completion date (PCD).

Drug: Sorafenib 400 mg (200-mg tablet)

Sorafenib 400 mg (Expansion)

EXPERIMENTAL

Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion. Treatment were planned until primary completion date (PCD). 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib until 18 Sep 2008.

Drug: Sorafenib 400 mg (Expansion)

Interventions

Sorafenib 100 mg (50-mg tablet)DRUG

Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)

Sorafenib 100 mg (50-mg tablet)
Sorafenib 200 mg (50-mg tablet)DRUG

Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)

Sorafenib 200 mg (50-mg tablet)
Sorafenib 400 mg (50-mg tablet)DRUG

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)

Sorafenib 400 mg (50-mg tablet)
Sorafenib 400 mg (200-mg tablet)DRUG

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)

Sorafenib 400 mg (200-mg tablet)
Sorafenib 400 mg (Expansion)DRUG

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Sorafenib 400 mg (Expansion)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed solid tumors
  • Evaluable disease
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Life expectancy minimum 12 weeks

You may not qualify if:

  • Congestive heart failure
  • Serious arrhythmias
  • Coronary artery disease (CAD) or ischemia
  • HIV (human immunodeficiency virus)
  • Hepatitis B or C
  • Serious active infection
  • Metastatic brain or meningeal tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma

Interventions

SorafenibTablets

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Therapeutic Area Head
Organization
BAYER
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2009

First Posted

July 20, 2009

Study Start

July 1, 2002

Primary Completion

May 1, 2005

Study Completion

April 1, 2008

Last Updated

March 22, 2016

Results First Posted

October 8, 2010

Record last verified: 2016-02

Locations

US(3)