A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
1 other identifier
interventional
103
1 country
2
Brief Summary
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2009
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 19, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2019
CompletedDecember 22, 2021
December 1, 2021
10.3 years
October 19, 2009
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
maximum tolerated dose
MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients
1-3 months
Secondary Outcomes (2)
tumor response rate
1-3 months
pharmacodynamic effects in skin and peripheral mononuclear cells
1-3 months
Study Arms (1)
sapacitabine and seliciclib
EXPERIMENTALSequential or concomitant administration of sapacitabine and seliciclib
Interventions
sequential or concomitant administration of sapacitabine and seliciclib
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Shapiro, M.D.
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Sara Tolaney, M.D.
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2009
First Posted
October 21, 2009
Study Start
April 1, 2009
Primary Completion
July 16, 2019
Study Completion
August 13, 2019
Last Updated
December 22, 2021
Record last verified: 2021-12