Advanced Solid TumorsPhase 1NCT00999401
A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
A Phase 1 study testing sapacitabine and seliciclib in people with Advanced Solid Tumors, run by Cyclacel Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- sapacitabine and seliciclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to 13 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- sapacitabine and seliciclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sapacitabine and seliciclibDrug
Also called CYC682 and CYC202
sequential or concomitant administration of sapacitabine and seliciclib
| Study group | Role | What they receive |
|---|---|---|
| sapacitabine and seliciclib | Experimental | Sequential or concomitant administration of sapacitabine and seliciclib Receives: Drug: sapacitabine and seliciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients
Measured: 1-3 months
Secondary outcomes (2)
tumor response rate
Anti-tumor activity of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.
Measured: 1-3 months
pharmacodynamic effects in skin and peripheral mononuclear cells
PD effect of the sequential treatment of sapacitabine and seliciclib in patients with advanced solid tumors.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startApr 2009
- Primary completion16 Jul 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoffrey Shapiro, M.D., Principal investigator, Dana-Farber Cancer InstituteSara Tolaney, M.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999401
- Sponsor's protocol ID
- CYC682-07
- Status last verified
- Dec 2021
- First submitted
- 19 Oct 2009
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00999401
- Acronym / sponsor ID
- CYC682-07
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of sequential administration of oral sapacitabine and oral Seliciclib in patients with advanced solid tumors.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sapacitabine and seliciclib | Experimental | Drug: sapacitabine and seliciclibSequential or concomitant administration of sapacitabine and seliciclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sapacitabine and seliciclibAlso: CYC682 and CYC202sequential or concomitant administration of sapacitabine and seliciclib | Drug | sapacitabine and seliciclib |
Primary outcome
maximum tolerated dose
Time frame: 1-3 months
MTD of both sapacitabine and seliciclib administered sequentially in advanced solid tumor patients
2 secondary outcomes
tumor response rate
Time frame: 1-3 months
pharmacodynamic effects in skin and peripheral mononuclear cells
Time frame: 1-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Results publicationShapiro GI, et al. Responses to sequential sapacitabine and seliciclib in patients with BRCA-deficient solid tumors. Cancer Res April 15, 2013 73; LB-202.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Shapiro, M.D. principal investigator
Dana-Farber Cancer Institute
Sara Tolaney, M.D. principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sapacitabine and seliciclib in people with Advanced Solid Tumors, run by Cyclacel Pharmaceuticals, Inc. 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 13 inclusion and 6 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 22 Dec 2021. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximum tolerated dose (time frame: 1-3 months). 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 NCT00999401, 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 22 Dec 2021.