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

Phase 1
18 Years
75 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

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

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).

Inclusion Criteria:

- 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

•≤ 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

- 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

Exclusion Criteria:

- 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

- 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

- 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

- Participation in another clinical trial or treatment with any investigational product
within 30 days prior to inclusion in this study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Number of Dose-Limiting Toxicities (DLTs)

Outcome Time Frame:

4 weeks after the first drug administration

Safety Issue:


Principal Investigator

Cristiana Sessa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Istituto Oncologico della Svizzera Italiana -6500 Bellinzona, Switzerland


Italy: Ethics Committee

Study ID:




Start Date:

November 2009

Completion Date:

March 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms