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A Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified November 2011 by Cyclacel Pharmaceuticals, Inc.
Sponsor:
Cyclacel Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Cyclacel Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00999401
First received: October 19, 2009
Last updated: May 2, 2016
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Advanced Solid Tumors | Drug: sapacitabine and seliciclib | Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Further study details as provided by Cyclacel Pharmaceuticals, Inc.:
Primary Outcome Measures:
- maximum tolerated dose [ Time Frame: 1-3 months ]
Secondary Outcome Measures:
- tumor response rate [ Time Frame: 1-3 months ]
- pharmacodynamic effects in skin and peripheral mononuclear cells [ Time Frame: 1-3 months ]
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: sapacitabine and seliciclib
Sequential or concomitant administration of sapacitabine and seliciclib
|
Drug: sapacitabine and seliciclib
sequential or concomitant administration of sapacitabine and seliciclib
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999401
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999401
Locations
| 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 | |
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Geoffrey Shapiro, M.D. | Dana-Farber Cancer Institute |
| Principal Investigator: | Sara Tolaney, M.D. | Dana-Farber Cancer Institute |
More Information
Additional Information:
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.
| Responsible Party: | Cyclacel Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00999401 History of Changes |
| Other Study ID Numbers: |
CYC682-07 |
| Study First Received: | October 19, 2009 |
| Last Updated: | May 2, 2016 |
Additional relevant MeSH terms:
|
Roscovitine Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 18, 2017