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Advanced Solid TumorsPhase 1NCT01155505

Lenalidomide and Paclitaxel in Advanced Solid Tumors

A Phase 1 study testing Lenalidomide (CC-5013) in people with Advanced Solid Tumors, run by Southern Europe New Drug Organization at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the maximum Tolerated Dose (MTD) of the combination of CC-5013 (Lenalidomide)and paclitaxel in patients with advanced solid tumors. Other purposes of the study are: 1. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Lenalidomide (CC-5013)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesin 2 countries
Study dates
Nov 2009to Mar 2012
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological/cytological diagnosis of solid tumors for which a treatment with paclitaxel could be indicated (preferentially ovary, breast, prostate, NSCLC)
  • Documented progression of the tumor in the 3 months preceding the study
  • Expected survival ≥ 3 months
  • Age 18-75 years
  • ECOG PS 0-1
  • measurable/evaluable disease during escalation phase, according to modified RECIST criteria. For patients with ovarian and prostatic cancer, tumor markers (CA125 for ovarian and PSA for prostatic) are accepted as only evidence. Measurable/evaluable disease is mandatory during the RD expansion phase
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  • •≤ 2 prior lines of chemotherapy for metastatic disease. For ovarian patients reintroduction of a platinum at relapse, after an initial response lasting > 6 months is considered one chemotherapy regimen only
  • Adequate contraception for all fertile patients
  • Adequate hematological function as defined by: ANC ≥ 1.5 x 109/L, platelet count ≥100 x 109/L, hemoglobin ≥ 10 g/dL.
  • Normal PTand INR; fibrinogen > lower Normal Limit (LNL)
  • Adequate renal function, as defined by: creatinine ≤ 1.5 x UNL
  • Adequate hepatobiliary function, as defined by the following baseline liver function tests:
  • total serum bilirubin within upper normal limit (UNL)
  • alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5xUNL or ≤ 5xUNL in case of liver metastases; alkaline phosphatase (AP) ≤ 2.5xUNL. If total alkaline phosphatase (AP) > 2.5xUNL, alkaline phosphatase liver fraction must be ≤ 2.5xUNL.
  • albumin ≥ 2.5 g/dL

Who cannot join

  • History of DVT or coagulation disturbances
  • Need of treatment with oral anticoagulants or LMW heparin
  • Clinical resistance to taxanes defined as progression during therapy or within 6 months from the end of adjuvant treatment
  • Known or prior hypersensitivity to taxanes or drugs containing chemophor, or to thalidomide (or analogues)
  • Preexisting peripheral neuropathy > grade 1
  • Concomitant treatment with non steroid anti-inflammatory agents (NSAIA), high dose steroids or immunosuppressants
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  • Concomitant hormonal treatment (including those with antiandrogenic)
  • Radiotherapy involving > 30% of the active bone marrow
  • Radiotherapy ≤ 4 weeks prior to enrolment
  • Other chemotherapy treatment ≤ 4 weeks prior to enrolment, at least 6 weeks for nitrosoureas or mitomycin C, or investigational drugs
  • Symptomatic brain metastases
  • Active infection
  • Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption
  • Impaired cardiac function including any of the following:
  • History of cardiac disease, such as myocardial infarction, in the year prior to enrollment in the clinical trial, symptomatic/uncontrolled angina pectoris, congestive heart failure or uncontrolled cardiac ischemia, or arrhythmia, abnormal left ventricular ejection fraction, or uncontrolled arterial hypertension.
  • Major surgery in the two weeks prior to entering the clinical trial
  • Concurrent treatment with any other anti-cancer therapy
  • History of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years
  • Patient unable to comply with the study protocol owing to psychological, social or geographical reasons
  • Pregnant and lactating women
  • Men and women of childbearing potential who are not using an effective method of contraception
  • Participation in another clinical trial or treatment with any investigational product within 30 days prior to inclusion in this study

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Italy1 site

  • Fondazione IRCSS Istituto Nazionale dei Tumori

    Milan, 20133

Other trials in Italy

Switzerland1 site

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 6500

Other trials in Switzerland

About this study

Official title: Phase Ib of CC-5013 and Paclitaxel in Patients With Advanced Solid Tumors

This is a dose finding, open-label, uncontrolled, dose-escalation trial to determine the maximum Tolerated Dose (MTD) of the combination of CC-5013 (Lenalidomide)and paclitaxel in patients with advanced solid tumors.

Other purposes of the study are:

  1. Define the safety profile of the CC-5013 and paclitaxel given in combination
  2. Define the pharmacokinetics of CC-5013 and paclitaxel given in combination
  3. Define the pharmacodynamic effects of the combination by monitoring potential biomarkers of the different biological activities of each component of the regimen
  4. Define the optimal biological dose (OBD) and the dose recommended (RD) for phase II studies in selected tumor types (breast, ovary, prostate, NSCLC)
  5. Collect evidence of antitumor activity in selected tumor types
Read the detailed description

The new immunomodulatory drugs (IMiD) derivatives of thalidomide (CC-5013 lenalidomide and CC4047 pomalidomide) are endowed of direct antitumor activity besides the indirect effects attributed to antiangiogenic, antiinflammatory and T-cell co-stimulatory properties.

Combination therapy with cytotoxic agents or other anticancer drugs could lead to additive or synergistic interactions and support their clinical development in tumor types in which the specific activities of IMiDs could be of potential value.

Combinations with weekly paclitaxel could be of interest because of its antiangiogenic activity, antitumor activity in prostate, NSCLC, ovary, breast cancer, tumor types in which IMiD could be of clinical value because of either enhancement of tumor specific immunity (ovary, prostate) or inhibition of Treg function (breast, NSCLC, ovary).

Being tested
Lenalidomide (CC-5013)

What participants receive

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

  • Lenalidomide (CC-5013)Drug

    CC-5013 given PO daily on D1-D14 every 21 days and Paclitaxel administered IV over 1 hour on d1 and 8 every 21 days until tumor progression or unacceptable toxicity

Study groups in NCT01155505
Study groupRoleWhat they receive
CC-5013 in combination with PaclitaxelExperimentalCohorts of 3 evaluable patients will initially be entered within each dose level, sequentially. In each dose level the second and third patient will enter 2 weeks after the first one. The second and third patient may be treated simultaneously, except if a DLT is reported in the first patient, in which case the second and third patient should be treated sequentially, at least one week apart. Dose escalation will be done when all the patients included in each DL will finish the first treatment cycle. Three additional patients will be sequentially entered (separated by one week each other) if one DLT is observed in cycle 1 among the first 3 patients entered within a dose level. If a DLT is observed in a second patient at this dose level, no further dose escalation will be allowed and the dose level will be considered the MTD. Once the RD (one level below the MTD) has been defined, additional patients (up to 12) will be treated in order to confirm the safety profile of the combination.
Receives: Drug: Lenalidomide (CC-5013)

What is being measured

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

  1. Define the MTD of the combination of CC-5013 and paclitaxel in patients with advanced solid tumors

    Number of Dose-Limiting Toxicities (DLTs)

    Measured: 4 weeks after the first drug administration

Secondary outcomes (4)

  1. Safety profile of the drug combination

    Physical examination, laboratory and instrumental assessments and AE type and frequency

    Measured: from the first administration to 30 days after the trial end

  2. Pharmacokinetics of CC-5013 and paclitaxel given in combination

    CC-5013 and paclitaxel plasma concentration

    Measured: untill 4 weeks after the first drug administration

  3. the pharmacodynamic effects of CC-5013 and paclitaxel given in combination

    Increase (%) in selected serum cytokines (IL2, IL6, IL10, IL12, TNFα, γIF and TGFβ).

    T-cell phenotyping:

    • T-cell markers (CD4/CD45RA/CCR7/CD3,CD8/CD45RA/CCR7/CD3)
    • Treg markers: CD4/CD25/FoxP3
    • NKcells: CD16+/CD56+

    Measured: from the first drug administration to 30 days after trial end

  4. Evidence of antitumor activity in selected tumor types

    Response Rate according to RECIST criteria

    Measured: From the first drug administration to 30 days after the trial end

Timeline

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

  1. First posted1 Jul 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionMar 2012 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01155505
Sponsor's protocol ID
S095LEPT01
Status last verified
Sep 2011
First submitted
30 Jun 2010
Last updated
13 Sep 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide (CC-5013) in people with Advanced Solid Tumors, run by Southern Europe New Drug Organization at 2 sites in 2 countries.

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 15 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy, Switzerland. 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?

Results are not available in the source record.

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?

Define the MTD of the combination of CC-5013 and paclitaxel in patients with advanced solid tumors (time frame: 4 weeks after the first drug administration). 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 NCT01155505.

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 13 Sep 2011.

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