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Metastatic MelanomaPhase 2NCT01933061

Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma

A Phase 2 study testing Abraxane in people with Metastatic Melanoma, run by Celgene Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma
What is being tested?
Abraxane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2014to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 1. Histologically or cytologically confirmed cutaneous BRAF wild-type malignant melanoma with evidence of metastasis (Stage IV).
  • 2. No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. No prior adjuvant cytotoxic chemotherapy is permitted.
  • Up to one prior regimen with the following classes of agents is permitted:
  • o Targeted biologic agents (e.g. interleukin 2 [IL-2], granulocyte macrophage colony stimulating factor [GM-CSF], other cytokines or unarmed monoclonal antibodies)
  • o Targeted small molecule inhibitors (e.g., kinase inhibitors, heat shock protein [HSP] inhibitors, etc.).
  • Immune checkpoint inhibitors (e.g. anti-CTLA4, anti-PD1, anti-PD-L1).
Show all 20Show fewer
  • Prior adjuvant therapy with interferon and/or vaccines is permitted.
  • Prior treatments should be completed 4 weeks prior to enrollment in the study (ie, randomization).
  • 3. Male or non-pregnant and non-lactating female, and ≥ 18 years of age at the time of signing the informed consent document.
  • If heterosexually active, the subject must agree to use medical doctor-approved contraception throughout the study, and for 6 months after last dose of study drug.
  • 4. History of malignancy in the last 5 years; subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
  • Subjects with other malignancies are eligible if they were cured by surgery (with or without radiotherapy) and have been continuously disease-free for at least 5 years.
  • 5. Radiographically-documented measurable disease (defined by the presence of at least one radiographically documented measurable lesion including measurable cutaneous metastasis).
  • 6. Adequate haemtological and biochemical parameters:
  • ANC ≥ 1.5 x 109 cells/L.
  • Platelets ≥ 100 x 109 cells/L.
  • Hgb ≥ 9 g/dL.
  • AST (SGOT) or ALT (SGPT) ≥ 2.5x upper limit of normal range (ULN);
  • o ≤ 5.0 x ULN if hepatic metastases present.
  • Total bilirubin ≤ ULN. Creatinine ≤ 1.5 mg/dL. 8. ECOG performance status 0 to 1.

Who cannot join

  • 1. History of or current evidence of symptomatic brain metastases (brain Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) is needed to exclude brain metastasis), including leptomeningeal involvement.
  • 2. Subject has pre-existing peripheral neuropathy of National Cancer Institute NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
  • 3. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.

About this study

Official title: A Randomized, Open Label, Multi-center Phase 2 Study of Nab-Paclitaxel Versus Epigenetic Modifying Therapy of CC-4386 With Nab-Paclitaxel in Subjects With Chemotherapy naïve Metastatic Melanoma

A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.

Read the detailed description

The study will consist of the following phases:

  • Screening (Baseline) Assessments: Performed within 21 days of randomization.
  • Randomization: Subjects will be randomized within 21 days of starting their Baseline assessments.
  • Treatment: Therapy may continue in the absence of clinically significant disease progression and unacceptable toxicity.
  • Response Assessments: Subjects will be evaluated by investigators for CR, PR, stable or progressive disease every 6 weeks from the start of treatment until progressive disease is documented.

Responders and subjects with stable disease (SD) should continue on study unless they develop unacceptable toxicity, they start a new anticancer therapy, withdrawal of consent, physician decision or death.

  • End of Study (EOS)/Treatment Evaluation: At the time subjects are removed from study, laboratory and clinical evaluations will be performed.
  • Follow-up for Disease Progression:
  • Subjects who stop treatment prior to developing disease progression should be followed without further treatment until progressive disease is documented or until the treating physician feels additional treatment is required.
  • Follow-up for Survival:
  • Post study, subject survival status will be monitored on a monthly basis for 6 months from discontinuation from the study and every 3 months thereafter, until death or study termination in all subjects.
Being tested
Abraxane
Keywords
Skin cancer, Melanoma
Medical subject headings
Melanoma

What participants receive

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

  • AbraxaneDrug

    Also called nab-paclitaxel, ABI-007

    Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle

  • AbraxaneDrug

    Also called nab-paclitaxel, ABI-007

    Abraxane 150 mg/m^2 intravenously on Days 1, 8, and 15 of a 28-day cycle

Study groups in NCT01933061
Study groupRoleWhat they receive
Abraxane 150 mg/m² Intravenous (IV)ExperimentalNot described
Receives: Drug: Abraxane
CC-486 orally plus Abraxane IVExperimentalNot described
Receives: Drug: Abraxane

What is being measured

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

  1. Progression-free survival (PFS)

    PFS is defined as the time from randomization date to disease progression according to RECIST response guideline

    Measured: Up to 24 months

Secondary outcomes (5)

  1. Overall survival (OS)

    OS is defined as the time from the date of randomization to the date of death.

    Measured: Up to 24 months

  2. PFS

    PFS based on investigator assessment; PFS is defined as the time from randomization date to disease progression according to RECIST response guideline

    Measured: Up to 24 months

  3. Objective Response Rate (ORR)

    Number (%) of subject who achieve an objective complete or partial response.

    Measured: Up to 24 months

  4. Disease Control Rate (DCR)

    Number (%) of subject with Stable Disease (SD) ≥ for 18 weeks or complete or partial response.

    Measured: Up to 24 months

  5. Safety

    Incidence and severity of Adverse events (AE) will be analyzed in terms of treatment-emergent AEs defined to be any AE that begin or worsen in severity after study drug initiation.

    Measured: Up to 24 months

Timeline

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

  1. First posted30 Aug 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2014
  4. Study completionJan 2014

Why it stopped: Strategic decision not to proceed with the opening of this study. There are no concerns over the safety or quality of the investigational products involved.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01933061
Sponsor's protocol ID
CC-486-MEL-001
Status last verified
Feb 2014
First submitted
28 Aug 2013
Last updated
4 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abraxane in people with Metastatic Melanoma, run by Celgene Corporation.

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 20 inclusion and 3 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: withdrawn, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression-free survival (PFS) (time frame: Up to 24 months). 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 NCT01933061.

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 4 Feb 2014.

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