A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT00999401 |
Recruitment Status : Unknown
Verified November 2011 by Cyclacel Pharmaceuticals, Inc..
Recruitment status was: Recruiting
First Posted : October 21, 2009
Last Update Posted : May 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Drug: sapacitabine and seliciclib | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors |
Study Start Date : | April 2009 |
Estimated Primary Completion Date : | July 2018 |
Estimated Study Completion Date : | July 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
|
Drug: sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib |
- maximum tolerated dose [ Time Frame: 1-3 months ]
- tumor response rate [ Time Frame: 1-3 months ]
- pharmacodynamic effects in skin and peripheral mononuclear cells [ Time Frame: 1-3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999401
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Geoffrey Shapiro, M.D. 617-632-4942 | |
Contact: Tracy Bell, R.N. 617.632.3482 | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Sara Tolaney, M.D. 617-632-2335 | |
Contact: Leilani Anderson, RN 617-632-3129 |
Principal Investigator: | Geoffrey Shapiro, M.D. | Dana-Farber Cancer Institute | |
Principal Investigator: | Sara Tolaney, M.D. | Dana-Farber Cancer Institute |
Publications of Results:
Responsible Party: | Cyclacel Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00999401 |
Other Study ID Numbers: |
CYC682-07 |
First Posted: | October 21, 2009 Key Record Dates |
Last Update Posted: | May 3, 2016 |
Last Verified: | November 2011 |
Neoplasms Roscovitine Sapacitabine Antineoplastic Agents Antiviral Agents |
Anti-Infective Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |