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Pancreatic CancerPhase 1/2NCT00540579

CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas

A Phase 1/2 study testing Pomalidomide and Gemcitabine in people with Pancreatic Cancer, run by SCRI Development Innovations, LLC at 2 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

Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Pomalidomide and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesUnited States
Study dates
Nov 2007to Jan 2011
Phase
Phase 1/2
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

  • Understand and voluntarily sign an informed consent form.
  • Age ≥ 18 years at the time of signing the informed consent form.
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • Histological or cytological documentation of adenocarcinoma of the pancreas with metastases not amenable to curative surgery or definitive radiation. Patients with locally advanced disease are not eligible.
  • Radiographic or clinical evidence of measurable advanced metastatic pancreatic carcinoma. Subjects must have measurable disease according to the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee for target lesions (see Appendix 14.2).
  • Subjects may have been previously treated with adjuvant radiation therapy and 5-fluorouracil or Gemzar as a radiosensitizer in the adjuvant setting if they currently have evidence of progression. Following completion of XRT, no further adjuvant chemotherapy with either Gemzar or 5-FU is permitted. No prior Gemzar® for metastatic disease or for primary treatment of locally advanced disease is allowed. Gemzar® used solely as a radiation sensitizer in the adjuvant setting is permitted.
  • ECOG performance status of 0 or 1.
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of starting CC-4047 and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking CC-4047. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure (see Appendix 14.6).

Who cannot join

  • Pregnant or lactating females.
  • Any serious medical condition or psychiatric illness that prevents the study subject from signing the informed consent form or places the study subject at an unacceptable risk if he or she participates in the study.
  • Prior therapy with CC-4047, lenalidomide, or thalidomide.
  • Prior use of systemic therapy for the treatment of adenocarcinoma of the pancreas with the exception of 5-fluorouracil or Gemzar® as a radiosensitizer in the adjuvant setting
  • Concurrent use of any other anti-cancer agents.
  • Any of the following laboratory abnormalities:
Show all 17Show fewer
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
  • Platelet count < 100,000 cells/ mm3 (100 x 109/L)
  • Serum creatinine > 2.5 mg/dL (221 μmol/L)
  • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN); in case of liver metastases > 5 x ULN
  • Serum total bilirubin > 2.0 mg/dL (34 μmol/L)
  • Surgery or radiation therapy within 14 days of study enrollment as outlined below.
  • Surgery within 14 days of the start of study (patients must have recovered from effects of surgery; 7 days may be considered for minor procedures).
  • Palliative radiation therapy within 14 days of the start of study. The radiation therapy may not be to the only site of measurable disease. Adjuvant therapy is permitted in accordance with the inclusion criteria.
  • Prior history of malignancy (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast, localized prostate cancer with PSA < 1.0 mg/dL) unless the subject has been free of disease for ≥ 3 years.
  • Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
  • Grade ≥ 2 neuropathy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37023

Other trials in United States

About this study

Official title: A Phase I/II Study of CC-4047 in Combination With Gemcitabine in Subjects With Untreated Advanced Carcinoma of the Pancreas

Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to determine the appropriate CC-4047 dose and regimen in combination with gemcitabine.

Read the detailed description

Phase I

Primary:

  • To determine the maximum tolerated dose (MTD) and evaluate the safety profile of oral CC-4047 given on days 1-21 in combination with gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.

Secondary:

  • To explore the anti-tumor activity of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.

Phase II

Primary:

  • To explore the anti-tumor activity of the combination of CC-4047 on days 1-21 and gemcitabine on days 1, 8, and 15 every 28 days in subjects with advanced pancreatic carcinoma.

Secondary:

  • To evaluate the safety profile of the combination of CC-4047 and gemcitabine as combination therapy in subjects with advanced pancreatic carcinoma.
Keywords
Pancreas, Untreated, Advanced, Gemcitabine, CC-4047
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • PomalidomideDrug

    Also called CC-4047

    Phase 1: Subjects will be enrolled in dose-escalating cohorts to be treated with CC-4047 on days 1-21 Phase II: Subjects will be enrolled to receive oral CC-4047 at the MTD days 1 - 21

  • GemcitabineDrug

    Also called Gemzar

    1000 mg/m2 IV on days 1, 8, and 15 of 28 day cycle

Study groups in NCT00540579
Study groupRoleWhat they receive
InterventionExperimentalAll patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
Receives: Drug: Pomalidomide; Drug: Gemcitabine

What is being measured

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

  1. Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects

    Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows:

    • Inability to Complete cycle 1 of therapy due to drug-related toxicity.
    • > Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care
    • Febrile neutropenia (absolute neutrophil count [ANC] <1,000/μL and fever >101° F (38.5° C))
    • Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the scheduled cycle 2, will not be considered DLT)
    • Platelet count < 25,000/μL
    • Inability to initiate Cycle 2, Day 1 therapy within 7 days of scheduled start (i.e. cannot delay the start of Cycle 2 by more than 7 days following the normal 7 day recovery period) due to drug-related toxicity.

    Measured: 6 months

  2. The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0

    The relative incidence of Grade 3/4 adverse events from protocol treatment as defined by Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

    Measured: 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 posted8 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2008
  4. Study completionJan 2011

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00540579
Sponsor's protocol ID
SCRI GI 105
Other IDs
PO-PANC-PI-009
Status last verified
Feb 2013
First submitted
5 Oct 2007
Last updated
13 Mar 2013
Data monitoring committee
Yes

Publications

  • Infante JR, Jones SF, Bendell JC, Spigel DR, Yardley DA, Weekes CD, Messersmith WA, Hainsworth JD, Burris HA 3rd. A phase I, dose-escalation study of pomalidomide (CC-4047) in combination with gemcitabine in metastatic pancreas cancer. Eur J Cancer. 2011 Jan;47(2):199-205. doi: 10.1016/j.ejca.2010.09.002. Epub 2010 Nov 2.

    PubMed 21051221

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pomalidomide and Gemcitabine in people with Pancreatic Cancer, run by SCRI Development Innovations, LLC at 2 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 8 inclusion and 17 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 13 Mar 2013. 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 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 13 Mar 2013). 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?

Determination of Maximum Tolerated Dose (MTD), The Dose of Study Drug(s) Which Causes <33% of Patients Treated to Experience Unacceptable Side Effects (time frame: 6 months). 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 NCT00540579, which also lists 1 linked publication.

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 Mar 2013.

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