A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer

NCT03258398

Last updated date
Study Location
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Microsatellite Stable Relapsed or Refractory Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- ECOG performance status of 0, 1, or 2

- Pathologically documented diagnosis of colorectal adenocarcinoma.

- Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease.

- Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥3 weeks before the start of study therapy.

- Part 2 only: Presence of radiographically measurable disease (defined as the presence of ≥1 lesion that measures ≥10 mm [≥15 mm for lymph nodes]). Measurable disease that was previously radiated is only permitted if progressing.

- Agrees to undergo a pretreatment and a post-treatment biopsy.

- Microsatellite stable disease determined by IHC and/or polymerase chain reaction (PCR).

- Adequate bone marrow function

- Adequate hepatic function

- Adequate renal function

- Normal coagulation profile

- Negative antiviral serology

- Female subjects of childbearing potential must not be pregnant or breastfeeding

- Willingness to use protocol-recommended methods of contraception or to abstain from heterosexual intercourse from start of therapy until at lest 30 days after the last dose of study therapy

- Life expectancy of ≥3 months.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of another malignancy except for adequately treated local basal cell or
squamous cell carcinoma of the skin; in situ cervical or breast carcinoma; adequately
treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2
cancers currently in complete remission, or any other cancer that has been in complete
remission for ≥2 years.


- Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its
equivalent).


- Significant cardiovascular disease.


- Significant screening ECG abnormalities.


- Active autoimmune disease that might deteriorate when receiving an immunostimulatory
agent.


- Known history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary
fibrosis.


- Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis.


- Evidence of an ongoing systemic bacterial, fungal, or viral infection.


- Any condition that may impact the subject's ability to swallow oral medications.


- Major surgery within 4 weeks before the start of study therapy.


- Prior solid organ or bone marrow progenitor cell transplantation.


- Prior therapy with any known inhibitor of MNK-1 or MNK-2.


- Prior therapy with any of the following: PD-1, PD-L1, CTLA4 antibody, or any other
drug targeting T cell checkpoint pathways.


- Prior high dose chemotherapy requiring stem cell rescue.


- Intolerance to or prior severe (≥Grade 3) allergic or anaphylactic reaction to infused
antibodies or infused therapeutic proteins.


- Vaccination within 4 weeks of the first dose of avelumab and while on study.


- Ongoing immunosuppressive therapy.


- Use of a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 7 days
prior to the start of study therapy or expected requirement for use of a strong CYP3A4
inhibitor or inducer during study therapy.


- Previously received investigational product in a clinical trial within 30 days or
within 5 elimination half lives (whichever is longer) prior to the start of study
therapy, or is planning to take part in another clinical trial while participating in
this study.


- Has any illness, medical condition, organ system dysfunction, or social situation,
including mental illness or substance abuse, deemed by the Investigator to be likely
to interfere with a subject's ability to sign informed consent, adversely affect the
subject's ability to cooperate and participate in the study, or compromise the
interpretation of study results

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Microsatellite Stable Relapsed or Refractory Colorectal CancerA Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer
NCT03258398
  1. Scottsdale, Arizona
  2. Denver, Colorado
  3. Sarasota, Florida
  4. Rochester, Minnesota
  5. Kansas City, Missouri
  6. Nashville, Tennessee
  7. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer
Official Title  ICMJE A Phase 2, Open-Label, Randomized, Non-Comparative Study With Preliminary Dose Finding to Evaluate eFT508 Monotherapy or eFT508 in Combination With Avelumab in Subjects With Microsatellite Stable Relapsed or Refractory Colorectal Cancer
Brief Summary This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
In Part 1, subjects will receive eFT508 in combination with a fixed dose of avelumab. Once the recommended dose of eFT508 in combination with avelumab is determined in Part 1, enrollment in Part 2 will begin. Subjects will be randomized in approximately a 2:1 ratio to receive eFT508 in combination with avelumab or eFT508 monotherapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Microsatellite Stable Relapsed or Refractory Colorectal Cancer
Intervention  ICMJE
  • Drug: eFT508
    eFT508 will be taken orally (PO) twice a day (bid).
  • Drug: Avelumab
    Avelumab 10 mg/kg will be administered intravenously (IV) on Day 1 and once every 2 weeks (q2wk) thereafter
Study Arms  ICMJE
  • Experimental: Part 1: eFT508 plus avelumab dose finding Arm
    subjects will receive eFT508 in combination with a fixed dose of avelumab
    Interventions:
    • Drug: eFT508
    • Drug: Avelumab
  • Experimental: Part 2: eFT508 plus avelumab
    subjects will receive eFT508 in combination with a fixed dose of avelumab
    Interventions:
    • Drug: eFT508
    • Drug: Avelumab
  • Experimental: Part 2: eFT508 alone
    subjects will receive eFT508 alone
    Intervention: Drug: eFT508
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2018)
56
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2017)
70
Actual Study Completion Date  ICMJE May 13, 2019
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ECOG performance status of 0, 1, or 2
  • Pathologically documented diagnosis of colorectal adenocarcinoma.
  • Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease.
  • Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ?3 weeks before the start of study therapy.
  • Part 2 only: Presence of radiographically measurable disease (defined as the presence of ?1 lesion that measures ?10 mm [?15 mm for lymph nodes]). Measurable disease that was previously radiated is only permitted if progressing.
  • Agrees to undergo a pretreatment and a post-treatment biopsy.
  • Microsatellite stable disease determined by IHC and/or polymerase chain reaction (PCR).
  • Adequate bone marrow function
  • Adequate hepatic function
  • Adequate renal function
  • Normal coagulation profile
  • Negative antiviral serology
  • Female subjects of childbearing potential must not be pregnant or breastfeeding
  • Willingness to use protocol-recommended methods of contraception or to abstain from heterosexual intercourse from start of therapy until at lest 30 days after the last dose of study therapy
  • Life expectancy of ?3 months.

Exclusion Criteria:

  • History of another malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical or breast carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ?2 years.
  • Known symptomatic brain metastases requiring ?10 mg/day of prednisolone (or its equivalent).
  • Significant cardiovascular disease.
  • Significant screening ECG abnormalities.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Known history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.
  • Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis.
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection.
  • Any condition that may impact the subject's ability to swallow oral medications.
  • Major surgery within 4 weeks before the start of study therapy.
  • Prior solid organ or bone marrow progenitor cell transplantation.
  • Prior therapy with any known inhibitor of MNK-1 or MNK-2.
  • Prior therapy with any of the following: PD-1, PD-L1, CTLA4 antibody, or any other drug targeting T cell checkpoint pathways.
  • Prior high dose chemotherapy requiring stem cell rescue.
  • Intolerance to or prior severe (?Grade 3) allergic or anaphylactic reaction to infused antibodies or infused therapeutic proteins.
  • Vaccination within 4 weeks of the first dose of avelumab and while on study.
  • Ongoing immunosuppressive therapy.
  • Use of a strong inhibitor or inducer of cytochrome P450 3A4 (CYP3A4) within 7 days prior to the start of study therapy or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study therapy.
  • Previously received investigational product in a clinical trial within 30 days or within 5 elimination half lives (whichever is longer) prior to the start of study therapy, or is planning to take part in another clinical trial while participating in this study.
  • Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, adversely affect the subject's ability to cooperate and participate in the study, or compromise the interpretation of study results
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03258398
Other Study ID Numbers  ICMJE eFT508-0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Effector Therapeutics
Study Sponsor  ICMJE Effector Therapeutics
Collaborators  ICMJE
  • Merck KGaA, Darmstadt, Germany
  • Pfizer
Investigators  ICMJE
Study Director:Jeremy Barton, MDCMO
PRS Account Effector Therapeutics
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP