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: November 7, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. The secondary objectives are to evaluate antitumor activity of this sequential 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Oral Sapacitabine and Oral Seliciclib in Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Cyclacel Pharmaceuticals, Inc.:
Primary Outcome Measures:
- maximum tolerated dose [ Time Frame: 1-3 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- tumor response rate [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
- pharmacodynamic effects in skin and peripheral mononuclear cells [ Time Frame: 1-3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: sapacitabine and seliciclib
Sequential administration of sapacitabine and seliciclib
|
Drug: sapacitabine and seliciclib
sequential administration of sapacitabine and seliciclib
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
- 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
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: Kristen Johnson, R.N. 617-632-5841 | |
| Principal Investigator: Geoffrey Shapiro, M.D. | |
Sponsors and Collaborators
Cyclacel Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Geoffrey Shapiro, M.D. | Dana-Farber Cancer Institute |
More Information
No publications provided
| 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: | November 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Roscovitine Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013