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NCT01804140 · REGISTRY CONDITION SEARCH

A Screening Study to Detect BRAF V600 Mutation-Positive Patients For Enrollment Into Clinical Research Studies of Zelboraf (Vemurafenib)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2016-11-02

This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as defined by this screening protocol will have potential access to the separate vemurafenib protocol MO28072.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type

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outcome · POSTED

Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator * Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Uncontrolled concurrent malignancy * Active or untreated CNS metastases * History of known carcinomatous meningitis * Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed) * Uncontrolled, severe medical illness or condition as defined in protocol MO28072
healthy Volunteers
false
minimum Age
18 Years
sampling Method
PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
study Population
Patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma
Treatment arms and interventions
arm Groups
  1. label
    Cohort
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
662
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer \[μm\] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.
    measure
    Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type
    time Frame
    Up to 1 year
  2. description
    FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.
    measure
    Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples
    time Frame
    Up to 1 year
Full study description
brief Summary
This is a screening study to detect BRAF V600 mutation-positive patients for enrollment into clinical research studies of Zelboraf (vemurafenib). Tumor samples will be collected and analyzed from eligible patients with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma. All institutions with identified patients as defined by this screening protocol will have potential access to the separate vemurafenib protocol MO28072.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      NCT01804140
      primary nct id
      NCT01804140
      source kind
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      source record id
      Source null
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      payload sha256
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-6d3463402038fa53c6b8
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT01804140
        end
        11
        exact text
        NCT01804140
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
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      source kind
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      source record id
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      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      ab18e691ef64da7b7765357bd7388d7e5e0a1ef63ff050304fa73c495c72cf40

    Preserved source evidence · Not medical advice