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CarcinomaPhase 1NCT00941863

Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

A Phase 1 study testing Sorafenib 100 mg (50-mg tablet), Sorafenib 200 mg (50-mg tablet) and Sorafenib 400 mg (50-mg tablet) in people with Carcinoma, run by Bayer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma
What is being tested?
Sorafenib 100 mg (50-mg tablet), Sorafenib 200 mg (50-mg tablet) and Sorafenib 400 mg (50-mg tablet)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
3 sitesUnited States
Study dates
Jul 2002to Apr 2008
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase I Study to Determine the Safety, Maximum Tolerated Dose, PK of BAY43-9006 in Repeated Cycles of 18 Days On/3 Days Off in Combination With Paclitaxel and Carboplatin Chemotherapy in Patients With Advanced, Refractory Solid Tumors

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.

Conditions
Carcinoma
Being tested
Sorafenib 100 mg (50-mg tablet), Sorafenib 200 mg (50-mg tablet), Sorafenib 400 mg (50-mg tablet), Sorafenib 400 mg (200-mg tablet), Sorafenib 400 mg (Expansion)
Keywords
Sorafenib, Advanced Solid Tumors, Maximum tolerated dose, Carboplatin and paclitaxel chemotherapy combination
Medical subject headings
Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib 100 mg (50-mg tablet)Drug

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

  • Sorafenib 200 mg (50-mg tablet)Drug

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

  • Sorafenib 400 mg (50-mg tablet)Drug

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

  • Sorafenib 400 mg (200-mg tablet)Drug

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

  • Sorafenib 400 mg (Expansion)Drug

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

Study groups in NCT00941863
Study groupRoleWhat they receive
Sorafenib 100 mg (50-mg tablet)ExperimentalDose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).
Receives: Drug: Sorafenib 100 mg (50-mg tablet)
Sorafenib 200 mg (50-mg tablet)ExperimentalDose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).
Receives: Drug: Sorafenib 200 mg (50-mg tablet)
Sorafenib 400 mg (50-mg tablet)ExperimentalDose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).
Receives: Drug: Sorafenib 400 mg (50-mg tablet)
Sorafenib 400 mg (200-mg tablet)ExperimentalDose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet). Treatment were planned until primary completion date (PCD).
Receives: Drug: Sorafenib 400 mg (200-mg tablet)
Sorafenib 400 mg (Expansion)ExperimentalDose-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.
Receives: Drug: Sorafenib 400 mg (Expansion)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 21 days

  2. 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.

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

Secondary outcomes (4)

  1. Tumor Response

    Tumor Response (= Best Overall Response) of a subject was defined as the best tumor response (confirmed Complete Response (CR), confirmed Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.

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

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

    The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. A plot of concentration vs time after dosing is created, and the area under this curve is calculated by standard methods (eg, trapezoidal rule) to provide a measure of how much drug was in the bloodstream following dosing.

    Measured: At day 2 in study

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

    Cmax refers to the highest plasma concentration of drug reached after dosing. It is obtained by collecting a series of blood samples after dosing, and analyzing them for drug content by a sensitive and specific analytical method. The highest measured concentration is referred to as the Cmax.

    Measured: At day 2 in study

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

    Tmax refers to the time after dosing when a drug attains its maximum concentration in the blood. It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. The time corresponding to the highest measurable concentration (Cmax) is referred to as Tmax.

    Measured: At day 2 in study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2009 (estimated)
  2. Study startJul 2002
  3. Primary completionMay 2005
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941863
Sponsor's protocol ID
100375
Status last verified
Feb 2016
First submitted
12 Jun 2009
Last updated
22 Mar 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sorafenib 100 mg (50-mg tablet), Sorafenib 200 mg (50-mg tablet) and Sorafenib 400 mg (50-mg tablet) in people with Carcinoma, run by Bayer at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00941863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

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