- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00999401
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
December 7, 2021 updated by: Cyclacel Pharmaceuticals, Inc.
A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this study is to determine the maximum tolerated dose (MTD) or recommended phase II doses of sapacitabine and seliciclib administered sequentially or concomitantly.
The secondary objectives are to evaluate antitumor activity of this sequential or concomitant treatment and to explore the pharmacodynamic effect of this treatment in skin and peripheral blood mononuclear cells.
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.
- Age 18 years or older
- ECOG 0-2
- Life expectancy ≥ 3 months
- Evaluable disease
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
- Able to swallow capsules
- At least 3 weeks from major surgery
- Agree to practice effective contraception
- Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
- Previously untreated CNS metastases or progressive CNS metastases
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness including
- Pregnant or lactating women
- Known to be HIV-positive
- A history of active hepatitis B and/or hepatitis C infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
|
sequential or concomitant administration of sapacitabine and seliciclib
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum tolerated dose
Time Frame: 1-3 months
|
MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients
|
1-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor response rate
Time Frame: 1-3 months
|
Anti-tumor activity of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.
|
1-3 months
|
pharmacodynamic effects in skin and peripheral mononuclear cells
Time Frame: 1-3 months
|
PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.
|
1-3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Geoffrey Shapiro, M.D., Dana-Farber Cancer Institute
- Principal Investigator: Sara Tolaney, M.D., Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Shapiro GI, et al. Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors. Cancer Res April 15, 2013 73; LB-202.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
July 16, 2019
Study Completion (Actual)
August 13, 2019
Study Registration Dates
First Submitted
October 19, 2009
First Submitted That Met QC Criteria
October 20, 2009
First Posted (Estimate)
October 21, 2009
Study Record Updates
Last Update Posted (Actual)
December 22, 2021
Last Update Submitted That Met QC Criteria
December 7, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYC682-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumors
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
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Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
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Vividion Therapeutics, Inc.RecruitingAdvanced Solid Tumors | Advanced Hematologic TumorsUnited States
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Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
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Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
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Cyclacel Pharmaceuticals, Inc.M.D. Anderson Cancer CenterUnknownAcute Myeloid Leukemia | Myelodysplastic SyndromesUnited States
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Cyclacel Pharmaceuticals, Inc.TerminatedA Randomized Phase II Study of Oral Sapacitabine in Patients With Advanced Cutaneous T-cell LymphomaCutaneous T-cell Lymphoma (CTCL)United States
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Cyclacel Pharmaceuticals, Inc.CompletedAcute Myeloid LeukemiaUnited States, Spain, France, Switzerland, Germany, Italy, Austria, Sweden, Hungary, Belgium, Poland, United Kingdom
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Cyclacel Pharmaceuticals, Inc.TerminatedNon-small Cell Lung CancerUnited States
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Cedars-Sinai Medical CenterRecruiting
-
Shlomo Melmed, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated